Important Safety Alerts

Important Safety Alerts

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16 Sep 2021 Beckman Coulter Inc. ACCESS SARS-CoV-2 IgG (1st IS)
16 Sep 2021 Cook Medical Inferior Vena Cava (IVC) Filters
15 Sep 2021 NuVasive Specialized Orthopedics Precice Bone Transport Nail
14 Sep 2021 Medical Device Safety Alert: Getinge MAQUET CARDIOSAVE hybrid and MAQUET CARDIOSAVE rescue
13 Sep 2021 Medical Device Safety Alert: Eco-Med Pharmaceutical, All Ultrasound Gels and Lotions
10 Sep 2021 Medical Device Safety Alert: Chalice Medical Ltd ParaTherm Heater/ Cooler
08 Sep 2021 bioMérieux MYLA SOFTWARE
08 Sep 2021 Beckman Coulter MicroScan Dried Gram Positive Combo and ID
31 Aug 2021 Medtronic DLP Left Heart Vent Catheters
27 Aug 2021 Medical Device Safety Alert: Maquet Cardiopulmonary GmbH HCU 40 Heater-Cooler Unit
27 Aug 2021 Medical Device Safety Alert: Philips HEARTSTART DEFIBRILLATION PADS
27 Aug 2021 Medical Device Safety Alert: Beckman Coulters Inorganic Phosphorus
24 Aug 2021 Boston Scientific Rezūm System
19 Aug 2021 Applied Medical Resources Corporation Alexis Contained Extraction System
19 Aug 2021 Smiths Medical Level 1 Fast Flow Fluid Warming System and Level 1 NORMOFLO Irrigation System
16 Aug 2021 Medtronic HeartWare Ventricular Assist Device (HVAD) System
16 Aug 2021 Medical Device Safety Alert: BioMérieux API 50 CH
12 Aug 2021 Boston Scientific Percuflex Plus Ureteral Stent
11 Aug 2021 Medline NAMIC MANIFOLD and STOPCOCKS
09 Aug 2021 Medical Device Safety Alert: BD PosiFlush Normal Saline Syringe
09 Aug 2021 Philips EPIQ Ultrasound Systems
06 Aug 2021 Medical Device Safety Alert: GS Elektromedizinische Geräte corpuls3 SLIM and corpuls3 Touch SLIM
04 Aug 2021 Abbott Alinity ci-series System Control Module (SCM)
04 Aug 2021 Medical Device Safety Alert: ConvaTec DuoDERM Extra Thin and DuoDERM CGF
23 Jul 2021 Boston Scientific TheraSphere Administration Sets
21 Jul 2021 Ethicon HARMONIC HD 1000i Shears
20 Jul 2021 Medical Device Safety Alert: Bio-Rad ID-Antigen Profile II
07 Jul 2021 Beckman Coulter HbA1c (Hemoglobin A1c) Reagent
05 Jul 2021 Medical Device Safety Alert: Kaluza C Software
24 Jun 2021 Roche Cobas u pack - International market only
21 Jun 2021 Beckman Coulter Access AMH Calibrators
21 Jun 2021 Ortho Clinical Diagnostics ORTHO VISION Analyzer for BioVue and ORTHO VISION Max Analyzer for BioVue
17 Jun 2021 Olympus Endocuff Vision
16 Jun 2021 Abbott Alinity c Activated Alanine Aminotransferase Reagent Kit (A‐ALT)
15 Jun 2021 BioFire FilmArray Pneumonia plus (PN plus) Panel
15 Jun 2021 Terumo Cardiovascular Terumo Advanced Perfusion System 1 – Electronic Patient Gas System (EPGS)
09 Jun 2021 Medical Device Safety Alert: Medtronic Stimloc Burr Hole Cover
09 Jun 2021 Boston Scientific Insufflation TRAPPER Exchange Device
07 Jun 2021 Medical Device Safety Alert: W.O.M. World of Medicine GmbH Aquilex Fluid Control System
04 Jun 2021 Boston Scientific INGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps).
03 Jun 2021 BioMerieux VIDAS Anti-HBs Total II
28 May 2021 Medical Device Safety Alert: KARL STORZ Insufflation Filter
28 May 2021 Medical Device Safety Alert: Beckman Coulter MicroScan Gram Negative panels with Amoxicillin/ K Clavulanate (Aug) and Ampicillin/Sulbactam (A/S)
27 May 2021 Baxter Healthcare Y-Type irrigation set; Spike with Clearlink (valve); Fast flow Y-type Irrigation set; Secondary Medication Set, Y-Type Blood/Solution Infusion Set with Clearlink Injection Site, Luer Lock Adaptor; Solution Administration Set with Clearlink; Solution Administration Set; Light Sensitive Drugs Set; Vented Paclitaxel Set
24 May 2021 Teleflex FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit, Ultra 8 IAB, UltraFlex IAB
21 May 2021 CAIR LGL Adapters with the C-Cure valve
20 May 2021 Medical Device Safety Alert: Beckman Coulter AU Creatine Kinase-MB (CK-MB) Reagent
20 May 2021 Medical Device Safety Alert: Lagis Enterprise Co. Ltd Metzenbaum Curved Scissors (EI-330S)
14 May 2021 Medical Device Safety Alert: QIAGEN NeuMoDx Cartridge
12 May 2021 Medical Device Safety Alert: bioMerieux MYLA V4.8.0/4.8.1 and MYLA V4.7.0/4.7.1
11 May 2021 Terumo HARVEST Platelet-Rich Plasma (PRP) Procedure Packs
10 May 2021 RaySearch Laboratories AB (publ) RayStation/RayPlan 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 2, including some service packs
05 May 2021 Medical Device Safety Alert: Johnson & Johnson GYNECARE INTERCEED 3INX4IN
05 May 2021 Medical Device Safety Alert: Terumo Cardiovascular Systems Sarns TCM and TCM II Cooling and Heating Systems; HX2 Temperature Management Systems
05 May 2021 Medical Device Safety Alert: Philips Continuous CT Fluoroscopy Digital Visual Interface (DVI) Ceiling Mount
03 May 2021 Medical Device Safety Alert: Philips Ingenia 1.5T, Ingenia 1.5T (S), Ingenia 1.5T CX, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition S, Ingenia Elition X, Smartpath to dStream 1.5T and Smartpath to dStream for XR and 3.0T
26 Apr 2021 Medical Device Safety Alert: Beckman Coulter PK7400 Automated Microplate System
26 Apr 2021 Medical Device Safety Alert: Medtronic Covidien DAR airway products
26 Apr 2021 Medical Device Safety Alert: Beckman Coulter MicroScan Gram Negative panels with Mecillinam
23 Apr 2021 Medical Device Safety Alert: Boston Scientific ELUVIA Drug Eluting Vascular Stent System
20 Apr 2021 Medical Device Safety Alert: Beckman Coulter Access 25(OH) Vitamin D Total for use on Access 2 and Dxl
20 Apr 2021 Medical Device Safety Alert: Beckman Coulter IMMAGE Immunochemistry Systems IgE Immunoglobulin E Reagent
19 Apr 2021 Medical Device Safety Alert: BArjo Nimbus 4 & Nimbus Professional Mattress
16 Apr 2021 Medical Device Safety Alert: Boston Scientific Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device & Colpassist Vaginal Positioning Device
15 Apr 2021 Medical Device Safety Alert: Boston Scientific POLARSHEATH Steerable Sheath
15 Apr 2021 Medical Device Safety Alert: Ortho Clinical Diagnostics 0.8% Resolve Panel B
14 Apr 2021 Medical Device Safety Alert: Boston Scientific VICI and VICI RDS Venous Stent Systems
13 Apr 2021 Medical Device Safety Alert: Beckman Coulter Access Sensitive Estradiol
01 Apr 2021 Medical Device Safety Alert: Roche Diagnostics cobas 6800/8800 Systems Rack Tray
31 Mar 2021 Medical Device Safety Alert: Beckman Coulter Access Sensitive Estradiol
30 Mar 2021 Medical Device Safety Alert: Boston Scientific AMS 700 Spherical and Conceal Reservoir with InhibiZone
30 Mar 2021 Medical Device Safety Alert: Macherey-Nagel GmbH & Co. KG Medi-Test Combi 11
30 Mar 2021 Medical Device Safety Alert: Smiths Medical ACE MDI Spacer with Small Mask and Palm Cups (Large)
30 Mar 2021 Medical Device Safety Alert: Smiths Medical Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, Tubing and LogiCal Kits
26 Mar 2021 Medical Device Safety Alert: Medtronic INTELLIS MODEL 97755 RECHARGER
24 Mar 2021 Medical Device Safety Alert: Medtronic VenaSeal Closure System
19 Mar 2021 Medical Device Safety Alert: Baxter Healthcare Colleague Single Channel CXE, Colleague Triple Channel CXE, EVO IQ LVP and EVO IQ SYR
16 Mar 2021 Medical Device Safety Alert: Abbott ASSURITY and ENDURITY pacemakers
16 Mar 2021 Medical Device Safety Alert: Boston Scientific EXALT Controller
15 Mar 2021 Medical Device Safety Alert: Beckman Coulter Access SARS-CoV-2 IgG II assay
12 Mar 2021 Medical Device Safety Alert: Becton Dickinson Infusion Sets for Alaris Pumps (GP, VP, CC, GW/GW800, SE, IVAC 590 series) and Gravity Infusion Sets & Connectors
11 Mar 2021 Medical Device Safety Alert: Teleflex Arrow OnControl Bone Lesion Biopsy System Tray
10 Mar 2021 Medical Device Safety Alert: Boston Scientific MAMBA 135 and MAMBA Flex 135 Microcatheters
09 Mar 2021 Medical Device Safety Alert: Baxter COLLEAGUE SINGLE CHANNEL CXE & COLLEAGUE TRIPLE CHANNEL CXE
09 Mar 2021 Medical Device Safety Alert: Abbott Amplatzer TorqVue LP (TVLP) System (80cm)
08 Mar 2021 Medical Device Safety Alert: Biotronik Implantable Cardioverter Defibrillators ("ICDs") and Cardiac Resynchronization Therapy Defibrillators ("CRT-Ds")
08 Mar 2021 Medical Device Safety Alert: Medtronic Covidien Signia Small Diameter Curved Tip Intelligent Reload
04 Mar 2021 Medical Device Safety Alert: Biosense Webster Irrigated Catheters
04 Mar 2021 Medical Device Safety Alert: Biosense Webster, CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
03 Mar 2021 Medical Device Safety Alert: Medtronic HeartWare HVAD Power Cables, Monitor Data Cables, and Controller Ports, HeartWare HVAD System
03 Mar 2021 Medical Device Safety Alert: Hologic Panther Fusion Tube Trays
03 Mar 2021 Medical Device Safety Alert: Accuray CyberKnife System with Standard Treatment Couch
03 Mar 2021 Medical Device Safety Alert: Karl Storz Hysteromat E.A.S.I
02 Mar 2021 Medical Device Safety Alert: DePuy Synthes MBT & ATTUNE Tibial Bases (S+)
01 Mar 2021 Medical Device Safety Alert: Beckman Coulter Access AMH Calibrators
01 Mar 2021 Medical Device Safety Alert: Beckman Coulter IMMAGE Immunochemistry System APB Apolipoprotein B Reagent, IMMAGE Immunochemistry System LPAX Lipoprotein (a) Reagent, IMMAGE Immunochemistry System PAB Prealbumin Reagent
01 Mar 2021 Medical Device Safety Alert: BioMérieux VIDAS CMV IgM
24 Feb 2021 Medical Device Safety Alert: RaySearch Laboratories AB (publ) RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, 10B, including some of the service packs
23 Feb 2021 Medical Device Safety Alert: Boston Scientific DC Bead, DC Bead M1, and DC Bead LUMI Radiopaque Microspheres
18 Feb 2021 Medical Device Safety Alert: Medtronic Valiant Navion Thoracic Stent Graft System
16 Feb 2021 Medical Device Safety Alert: In2Bones SAS-Pack 5 Shannon burrs
11 Feb 2021 Medical Device Safety Alert: Stryker SILVERGlide Non-Stick Precision Bipolar Forceps
11 Feb 2021 Medical Device Safety Alert: Steripack S.A Steriflush Prefilled 0.9% Sodium Chloride Syringes and Procedure Packs Containing Steriflush Prefilled 0.9% Sodium Chloride Syringes
09 Feb 2021 Medical Device Safety Alert: Maquet Heater-Cooler Unit HCU 40
08 Feb 2021 Medical Device Safety Alert: Boston Scientific 4G LATITUDE MIMIC Cell Adapter
04 Feb 2021 Medical Device Safety Alert: Baxter Prismaflex Control Unit
29 Jan 2021 Medical Device Safety Alert: BioFire Diagnostics BioFire FilmArray Blood Culture Identification (BCID) Panel and BioFire Blood Culture Identification 2 (BCID2) Panel used with BD BACTECTM Blood Culture Vials
25 Jan 2021 Medical Device Safety Alert: Getinge SERViNO and SoKINOX NO delivery and monitoring system
22 Jan 2021 Medical Device Safety Alert: ConvaTec AQUACEL Ag Dressing
21 Jan 2021 Medical Device Safety Alert: Sartorius Minisart NML / Ophthalsart
19 Jan 2021 Medical Device Safety Alert: Medtronic Strata II, Delta, and CSF-Flow Control Valves and Shunts
11 Jan 2021 Medical Device Safety Alert: Philips V680 Ventilators (Backup Battery)
11 Jan 2021 Medical Device Safety Alert: Philips Healthcare Philips V680 ventilators (Navigation Ring)
06 Jan 2021 Medical Device Safety Alert: Baxter ArtiSet Blood Tubing Sets (Product Codes: 955075, 955077)
04 Jan 2021 Medical Device Safety Alert: Beckman Coulter Access SARS-CoV-2 IgG Quality Control
30 Dec 2020 Medical Device Safety Alert: Draeger Medical Systems Inc - Infinity Acute Care System Infinity M540 Stand Alone Patient Monitor
30 Dec 2020 Medical Device Safety Alert: Bio-Rad Immunohematology reagents
24 Dec 2020 Medical Device Safety Alert: DePuy Pinnacle CUP Devices
24 Dec 2020 Medical Device Safety Alert: Baxter EVO IQ Large Volumetric Pump (LVP) UKI (ELVP001UKI)
23 Dec 2020 Medical Device Safety Alert: Getinge Washer Disinfector CM320
23 Dec 2020 Medical Device Safety Alert: Medtronic A710 Intellis Software Application [Affected version: Software version 1.3.80]
21 Dec 2020 Medical Device Safety Alert: Sentec AG Sentec Digital Monitor (UDI-DI:07640121880018)
18 Dec 2020 Medical Device Safety Alert: Boston Scientific ASSY STERILE CUTTER GLOBAL "Model 7060 ACUITY Cutter"
17 Dec 2020 Medical Device Safety Alert: Arjo Minstrel passive floor lift with scale
17 Dec 2020 Medical Device Safety Alert: Olympus EndoTherapy Devices
17 Dec 2020 Medical Device Safety Alert: Cook Medical Disposable Humidification Flask (K-MINC-CTS-S QCR-106)
16 Dec 2020 Medical Device Safety Alert: The JET 7 Xtra Flex catheter and The JET 7MAX configuration
14 Dec 2020 Medical Device Safety Alert: Hamilton Medical HAMILTON-H900
14 Dec 2020 Medical Device Safety Alert: Antibiotic Impregnated (ARES) Catheters (Part numbers: 91101, 93092, 95001).
10 Dec 2020 Medical Device Safety Alert: Remote Diagnostic Technologies Tempus LS [REF: 00-3010; UDI-DI: 07613365001693] with Software Version 1.3.4.
09 Dec 2020 Medical Device Safety Alert: Philips M3002A (865039) IntelliVue X2 and M8102A (865040) IntelliVue MP2
08 Dec 2020 Medical Device Safety Alert: Medtronic SynchroMed II Implantable Drug Infusion Pump (Model 8637)
26 Nov 2020 Medical Device Safety Alert: Cook Medical Flexor Check-Flo Introducer and Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select)
25 Nov 2020 Medical Device Safety Alert: Roche cobas z 480 analyzer
24 Nov 2020 Medical Device Safety Alert: Boston Scientific lceFORCE, lcePearl, lceRod, lceSphere, lceSeed, lceEDGE Cryoablation Needles and Prostate Cryoablation Kits
19 Nov 2020 Medical Device Safety Alert: Baxter dialysis machines
19 Nov 2020 Medical Device Safety Alert: Boston Scientific LOTUS Edge Valve System
17 Nov 2020 Medical Device Safety Alert: Baxter dialysis machines
17 Nov 2020 Medical Device Safety Alert: Medtronic Capnostream 35 Portable Respiratory Monitor
16 Nov 2020 Medical Device Safety Alert: Abbott Alinity i Active-B12 products
13 Nov 2020 Medical Device Safety Alert: RaySearch Laboratories RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B & 10A, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B & 10A
10 Nov 2020 Medical Device Safety Alert: SIS Medical OPN NC Super High Pressure PTCA Balloon
06 Nov 2020 Medical Device Safety Alert: Philips V60 Ventilators
06 Nov 2020 Medical Device Safety Alert: Olympus Endoscopic Ultrasound Endoscopes
03 Nov 2020 Medical Device Safety Alert: Abbott ARCHITECT EBV VCA IgM Calibrator
30 Oct 2020 Medical Device Safety Alert: Laerdal Compact Suction Unit 4 (LCSU 4)
30 Oct 2020 Medical Device Safety Alert: Stryker Zyphr Disposable Cranial Perforator Large 14/11 mm
12 Oct 2020 Medical Device Safety Alert: RaySearch Laboratories RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, including all service packs
08 Oct 2020 Medical Device Safety Alert: Abbott Alinity ci-series System Control Module [List Number: 03R70-01]
06 Oct 2020 Medical Device Safety Alert: Boston Scientific LATITUDE Programming Systems Model 3300 installed with Model 3892 v1.04 Altrua/ Insignia I/ Nexus I Support Application
30 Sep 2020 Medical Device Safety Alert: Stryker Osteosynthesis Compression Staple EasyClip and EasyClip Xpress implants
30 Sep 2020 Medical Device Safety Alert: Stryker Trevo XP ProVue Retriever
28 Sep 2020 Medical Device Safety Alert: Diatron M2400 Reaction Cuvette for Pictus Analyzers
28 Sep 2020 Medical Device Safety Alert: Boston Scientific AMS 700 with MS Pump
25 Sep 2020 Medical Device Safety Alert: Boston Scientific Visual-ICE MRI Mobile Connection Panel
24 Sep 2020 Medical Device Safety Alert: Medtronic Covidien Palindrome RT chronic hemodialysis catheters
21 Sep 2020 Medical Device Safety Alert: Boston Scientific Corporation Deep Brain Stimulators
18 Sep 2020 Medical Device Safety Alert: Boston Scientific Corporation Hurricane RX Biliary Balloon Dilatation Catheter
17 Sep 2020 Medical Device Safety Alert: Olympus BF-1T180 and BF-XT160 Bronchovideoscope
11 Sep 2020 Medical Device Safety Alert: Getinge Mobile OR-Table MEERA, YUNO and YUNO II
10 Sep 2020 Medical Device Safety Alert: Water-Circulating Hot/Cold Therapy Devices
03 Sep 2020 Medical Device Safety Alert: Olympus BF-Q180 Video Bronchoscope
02 Sep 2020 Medical Device Safety Alert: Olympus CHF-CB30S Choledochoscopes
01 Sep 2020 Medical Device Safety Alert: Terumo Advanced Perfusion System 1 -- Air Bubble Detector (ABD) Sensor
28 Aug 2020 Medical Device Safety Alert: Abbott Inquiry Steerable Diagnostic Catheters
26 Aug 2020 Medical Device Safety Alert: Boston Scientific Opticross 35 8F Peripheral Imaging Catheter
20 Aug 2020 Medical Device Safety Alert: Lohmann & Rauscher GmbH & Co. KG Gauze compresses with x-ray contrast thread in Kitpack and SetPack
18 Aug 2020 Medical Device Safety Alert: bioMerieux CHOCOLATE POLYVITEX
17 Aug 2020 Medical Device Safety Alert: Maquet Cardiopulmonary GmbH Heater-Cooler Unit HCU 40
12 Aug 2020 Medical Device Safety Alert: Cook Medical Zenith Alpha Abdominal Endovascular Graft
10 Aug 2020 Medical Device Safety Alert: Roche Elecsys Anti-TPO assay
10 Aug 2020 Medical Device Safety Alert: ZEISS VISULENS 550 digital lensmeter
06 Aug 2020 Medical Device Safety Alert: Boston Scientific Imager II Angiographic Catheter - 5 French Curved Tip Shapes
05 Aug 2020 Medical Device Safety Alert: Boston Scientific Wallflex Biliary RX Fully Covered Stent System RMV
31 Jul 2020 Medical Device Safety Alert: Deep Brain Stimulators in Parkinson's Patients
30 Jul 2020 Medical Device Safety Alert: Olympus Pleuravideoscope LTF-160 and LTF-240
27 Jul 2020 Medical Device Safety Alert: Getinge Nitric Oxide (NO) Delivery and Monitoring Systems
22 Jul 2020 Medical Device Safety Alert: Baxter Healthcare EVO IQ Large Volumetric Pump
21 Jul 2020 Medical Device Safety Alert: Greiner Bio-One VACUETTE 2mL 9NC Coagulation Sodium Citrate Tube
21 Jul 2020 Medical Device Safety Alert: Brainlab AG Curve and Kick Navigation Systems
20 Jul 2020 Medical Device Safety Alert: Medtronic MiniMed Guardian Connect App Connectivity to Carelink Personal Software
17 Jul 2020 Medical Device Safety Alert: Nobel Biocare NobelReplace CC PMC RP 4.3x10mm
24 Jun 2020 Medical Device Safety Alert: Illumina Inc Infinium Accessory Kits
03 Jun 2020 Medical Device Safety Alert: Cook Medical Zenith Alpha Abdominal Endovascular Graft
29 May 2020 Medical Device Safety Alert: Teleflex Arrow AutoCAT 2 Intra-Aortic Balloon Pump and Arrow AC3 Optimus Intra-Aortic Balloon Pump
27 May 2020 Medical Device Safety Alert: Abbott TactiCath Quartz Contact Force Ablation Catheter
19 May 2020 Medical Device Safety Alert: Tandem Diabetes Care t:slim X2 Insulin Pump
18 May 2020 Medical Device Safety Alert: FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test
11 May 2020 Medical Device Safety Alert: Stryker Trauma GmbH T2 Locking Screws, Compression Screws, End Caps, Gamma3 End Caps
07 May 2020 Medical Device Safety Alert: Medtronic MiniMed Implantable Pump
06 May 2020 Medical Device Safety Alert: Medtronic SOFTWARE 1898072 IPC UPGRADE v2.7.3.0
29 Apr 2020 Medical Device Safety Alert: Baxter Healthcare Corporation ARTISET Blood Tubing Sets
27 Apr 2020 Medical Device Safety Alert: Philips Healthcare Chest Pneumograph NM, 3160
24 Apr 2020 Medical Device Safety Alert: Roche cobas 6500 urine analyzer series with software version 2.2.0 - 2.2.8
21 Apr 2020 Medical Device Safety Alert: Beckman Coulter Access hsTnI (High Sensitivity Troponin I) Assay
08 Apr 2020 Medical Device Safety Alert: Beckman Coulter AutoMate 2500 Family
02 Apr 2020 Medical Device Safety Alert: Boston Scientific GreenLight MoXy Laser Fiber
01 Apr 2020 Medical Device Safety Alert: Baxter Prismaflex Control Unit
26 Mar 2020 Medical Device Safety Alert: Getinge HEMASHIELD GOLD--Knitted Microvel Double Velour Vascular Graft and HEMASHIELD PLATINUM--Woven Double Velour Vascular Graft
24 Mar 2020 Medical Device Safety Alert: Drive DeVilbiss 525/1025 Oxygen Concentrators
24 Mar 2020 Medical Device Safety Alert: Philips V60 Ventilators
23 Mar 2020 Medical Device Safety Alert: FDA Ventilator Supply Mitigation Strategies
23 Mar 2020 Medical Device Safety Alert: FDA Medical Glove Conservation Strategies
23 Mar 2020 Medical Device Safety Alert: Applied Medical Epix Laparoscopic Grasper
20 Mar 2020 Medical Device Safety Alert: Axis-Shield Diagnostics Alere NT-proBNP for ARCHITECT and Alinity i Calibrators and Controls
20 Mar 2020 Medical Device Safety Alert: Abbott Laboratories Alinity s System
19 Mar 2020 Medical Device Safety Alert: Merit Medical PreludeSYNC DISTAL Radial Compression Devices
17 Mar 2020 Medical Device Safety Alert: Medtronic CareLink 2090 Programmer with Software Application SW034 version 8.3 and Encore 29901 Programmer with Software Application SW034 version 8.3
16 Mar 2020 Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillator
13 Mar 2020 Medical Device Safety Alert: Abbott Alinity ci‐series System Control Module
13 Mar 2020 Medical Device Safety Alert: FDA Surgical Mask and Gown Conservation Strategies
13 Mar 2020 Medical Device Safety Alert: Philips Expression MR400 MRI Patient Monitoring System
11 Mar 2020 Medical Device Safety Alert: Boston Scientific Sensor Nitinol Guidewire with Hydrophilic Tip
09 Mar 2020 Medical Device Safety Alert: RaySearch Laboratories RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation/RayPlan 7, RayStation/RayPlan 8A, RayStation/RayPlan 8B, RayStation/RayPlan
06 Mar 2020 Medical Device Safety Alert: Bio-Rad Laboratories Assayed VIROTROL II-B and VIROTROL II
05 Mar 2020 Medical Device Safety Alert: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
04 Mar 2020 Medical Device Safety Alert: Medical Devices with Bluetooth Low Energy
26 Feb 2020 Medical Device Safety Alert: Laparoscopic Power Morcellators when used in gynecologic procedures
25 Feb 2020 Medical Device Safety Alert: Cardiac Science G3 Elite AED
21 Feb 2020 Medical Device Safety Alert: CareFusion 303 BD Alaris Systems
21 Feb 2020 Medical Device Safety Alert: Micro Therapeutics Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
17 Feb 2020 Medical Device Safety Alert: Boston Scientific LATITUDE Programming System
14 Feb 2020 Medical Device Safety Alert: CAIR LGL Infusion Stopcock with Mobile Ring
13 Feb 2020 Medical Device Safety Alert: Cardinal Health Surgical Gowns and Surgical Packs
13 Feb 2020 Medical Device Safety Alert: Baxter Prismaflex Control Unit
12 Feb 2020 Medical Device Safety Alert: Medtronic Valiant Navion Thoracic Stent Graft System
10 Feb 2020 Medical Device Safety Alert: Schiller Medical DEFIGARD Touch7
05 Feb 2020 Medical Device Safety Alert: Philips Efficia Combined Cable
05 Feb 2020 Medical Device Safety Alert: Medical Developments International Limited Breath-A-Tech (Standard and Hospital Grade) Spacers
04 Feb 2020 Medical Device Safety Alert: Medtronic HeartWare HVAD System Battery Charger AC Adapter and Controller
02 Feb 2020 Medical Device Safety Alert: Medtronic Evolut Transcatheter Aortic Valve
30 Jan 2020 Medical Device Safety Alert: Abbott NC Trek RX Coronary Dilatation Catheter and NC Traveler RX Coronary Dilatation Catheter [Balloon diameters 4.0mm, 4.5mm and 5.0mm]
29 Jan 2020 Medical Device Safety Alert: Medtronic McGRATH X3 Disposable Laryngoscope Blades
24 Jan 2020 Medical Device Safety Alert: Roche Elecsys CA 19-9 with reagent lot 416245 on cobas e 801
24 Jan 2020 Medical Device Safety Alert: Medtronic CONTOUR NEXT LINK 2.4
23 Jan 2020 Medical Device Safety Alert: Abbott Ellipse Implantable Cardioverter Defibrillators
23 Jan 2020 Medical Device Safety Alert: Medtronic Covidien Endo GIA Ultra Universal Stapler
23 Jan 2020 Medical Device Safety Alert: Baxter Healthcare Corporation Artiset Blood Tubing Sets
17 Jan 2020 Medical Device Safety Alert: Cardinal Health Level 3 surgical gowns and accompanying PreSource procedural packs
17 Jan 2020 Medical Device Safety Alert: Terumo Advanced Perfusion System 1 – 4 Inch and 6 Inch Roller Pump Shafts
17 Jan 2020 Medical Device Safety Alert: Cook Medical Zenith Alpha Spiral-Z Endovascular Leg
16 Jan 2020 Medical Device Safety Alert: Eurogine SL Intrauterine Devices (Updates)
15 Jan 2020 Medical Device Safety Alert: bioMérieux NucliSENS Lysis Buffer
07 Jan 2020 Medical Device Safety Alert: WEINMANN MEDUCORE Standard2 monitor/defibrillator WM 45300
07 Jan 2020 Medical Device Safety Alert: Argon Medical Devices Worker Guidewire Amplatz, Straight
31 Dec 2019 Medical Device Safety Alert: Abbott Alinity hq Analyzer
27 Dec 2019 Medical Device Safety Alert: Mavidon Lemon Prep, Pedia Prep, Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers
27 Dec 2019 Medical Device Safety Alert: Johnson & Johnson Vision Care 1-DAY ACUVUE TruEye brand contact lenses (30-Pack Lot Number: 5840330112)
27 Dec 2019 Medical Device Safety Alert: Fast Track Diagnostics All FTD CE-IVD kits
24 Dec 2019 Medical Device Safety Alert: Roche Cobas Infinity Core License
20 Dec 2019 Medical Device Safety Alert: RaySearch Laboratories RayStation 4.0, RayStation 4.3 (InverseArc), RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation/RayPlan 7, RayStation/RayPlan 8A, RayStation/Ra
19 Dec 2019 Medical Device Safety Alert: Medtronic Polysorb Braided Absorbable Sutures and Biosyn Monofilament Absorbable Sutures
16 Dec 2019 Medical Device Safety Alert: Synthes GmbH 1.0mm Cloverleaf Footplates and AB & BC Distractor Bodies
12 Dec 2019 Medical Device Safety Alert: Laboratoires Anios ANIOSYME DD1
12 Dec 2019 Medical Device Safety Alert: Abbott Fast-Cath Trio Hemostasis Introducer
10 Dec 2019 Medical Device Safety Alert: Abbott HeartMate 3 Modular Cables and HeartMate 3 Left Ventricular Assist System (LVAS) Kit
06 Dec 2019 Medical Device Safety Alert: Abbott Laboratories ARCHITECT Reaction Vessels
05 Dec 2019 Medical Device Safety Alert: Laboratoires Anios SURFA'SAFE PREMIUM
04 Dec 2019 Medical Device Safety Alert: Boston Scientific EMBLEM S-ICD Subcutaneous Electrode (Model 3501)
04 Dec 2019 Medical Device Safety Alert: bioMerieux VIDAS Varicella-Zoster IgG (VZG)
04 Dec 2019 Medical Device Safety Alert: Gebruder Martin GmbH & Co. KG Scalpel Blade, Sterile
03 Dec 2019 Medical Device Safety Alert: Johnson & Johnson Vision Healon GV PRO Sodium Hyaluronate Ophthalmic Viscosurgical Devices
03 Dec 2019 Medical Device Safety Alert: Roche Accu-Chek Aviva blood glucose meters
28 Nov 2019 Medical Device Safety Alert: Dexcom G6 iOS App
27 Nov 2019 Medical Device Safety Alert: Medtronic MiniMed 600 series insulin pumps
27 Nov 2019 Medical Device Safety Alert: Da Yo Medical Co. Ltd. PROGEL
25 Nov 2019 Medical Device Safety Alert: Philips Medical Systems Efficia Monitor CM10, CM12, CM100 and CM120
25 Nov 2019 Medical Device Safety Alert: Tianjin Grand Paper Industrial Co., Ltd ULTRASOUND GEL
21 Nov 2019 Medical Device Safety Alert: Stryker Pin To Rod Coupling Hoffmann II Compact 5/3-4mm
21 Nov 2019 Medical Device Safety Alert: RaySearch Laboratories RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation/RayPlan7, RayStation/RayPlan 8A, RayStation/RayPlan 8B and RayStation/RayPla
19 Nov 2019 Medical Device Safety Alert: ISD Meditech Sky Gel
18 Nov 2019 Medical Device Safety Alert: Philips Efficia DFM100 Defibrillator/ Monitor
18 Nov 2019 Medical Device Safety Alert: Philips HeartStart XL+ Defibrillator/Monitor
16 Nov 2019 Medical Device Safety Alert: Roche Accu-Chek Aviva test strips
14 Nov 2019 Medical Device Safety Alert: USF Healthcare UNISEPTA FOAM 2
11 Nov 2019 Medical Device Safety Alert: Laboratoires Anios OPASTER ANIOS
08 Nov 2019 Medical Device Safety Alert: Roche Accu-Chek Performa blood glucose meter
05 Nov 2019 Medical Device Safety Alert: Beckman Coulter iQ200 Series Urine Microscopy Analyzer and iChemVELOCITY Urine Chemistry System
05 Nov 2019 Medical Device Safety Alert: Beckman Coulter iChemVELOCITY Urine Chemistry System
23 Oct 2019 Medical Device Safety Alert: BioMerieux VIDAS 3
22 Oct 2019 Medical Device Safety Alert: Cook Medical Torcon NB Advantage Catheter
22 Oct 2019 Medical Device Safety Alert: Roche Accu-Chek Guide blood glucose meters
21 Oct 2019 Medical Device Safety Alert: Medtronic SynchroMed II Implantable Infusion Pumps
09 Oct 2019 Medical Device Safety Alert: Beckman Coulter UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II
04 Oct 2019 Medical Device Safety Alert: Medtronic Programmer and Remote Monitoring Software Applications
04 Oct 2019 Medical Device Safety Alert: Beckman Coulter REMISOL Advance Versions 1.6 to 1.9
27 Sep 2019 Medical Device Safety Alert: Medical Device Safety Alert: Association between Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) – Update
13 Sep 2019 Medical Device Safety Alert: Bio-Rad DC-Screening II
09 Sep 2019 Medical Device Safety Alert: Ethicon STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices
05 Sep 2019 Medical Device Safety Alert: Allergan BIOCELL textured breast implants and/or tissue expanders
04 Sep 2019 Medical Device Safety Alert: B. Braun lntrocan Safety Catheters 24G
03 Sep 2019 Medical Device Safety Alert: ConvaTec Convex Two-Piece Skin Barriers
02 Sep 2019 Medical Device Safety Alert: Roche ALB2 (Albumin Gen.2)
27 Aug 2019 Medical Device Safety Alert: Boston Scientific EMBLEM Subcutaneous Implantable Cardioverter Defibrillators (S-ICDs) and EMBLEM MRI S-ICDs
23 Aug 2019 Medical Device Safety Alert: Boston Scientific Zoom LATITUDE Programmer
21 Aug 2019 Medical Device Safety Alert: Roche Tina-quant Soluble Transferrin Receptor (sTFR) assay
14 Aug 2019 Medical Device Safety Alert: Arjo Concerto & Basic Shower Trolleys
09 Aug 2019 Medical Device Safety Alert: Biomerieux VIDAS FT4
09 Aug 2019 Medical Device Safety Alert: Nobel Biocare Titanium abutments
07 Aug 2019 Medical Device Safety Alert: Medtronic Micra Delivery System
01 Aug 2019 Medical Device Safety Alert: Medtronic ClosureRFG Radiofrequency Generator RFG3
26 Jul 2019 Medical Device Safety Alert: Tem Innovations GmbH ROTEM ex-tem
26 Jul 2019 Medical Device Safety Alert: Bio-Rad Coombs-Control IgG
19 Jul 2019 Medical Device Safety Alert: Roche ONLINE TDM Vancomycin Gen.3
18 Jul 2019 Medical Device Safety Alert: Teleflex NEONATAL ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column
16 Jul 2019 Medical Device Safety Alert: Abbott MULTIGENT Lithium and Alinity c Lithium Reagent Kit
15 Jul 2019 Medical Device Safety Alert: Philips Azurion System with software version 1.2
09 Jul 2019 Medical Device Safety Alert: Smiths Medical GRIPPER Non-Coring Safety Needle, PORT-A-CATH system
08 Jul 2019 Medical Device Safety Alert: Roche Elecsys Anti-CCP
05 Jul 2019 Medical Device Safety Alert: Infrared saunas not authorized to treat any medical conditions
26 Jun 2019 Medical Device Safety Alert: Abbott Ellipse Implantable Cardioverter Defibrillators
24 Jun 2019 Medical Device Safety Alert: Cyclomedica TechnegasPlus Generator
19 Jun 2019 Medical Device Safety Alert: Abbott ARCHITECT Ceruloplasmin and Alinity c Ceruloplasmin Reagent Kit
19 Jun 2019 Medical Device Safety Alert: Abbott GmbH & Co. KG Alinity ci-series System Control Module
17 Jun 2019 Medical Device Safety Alert: Bio-Rad DiaClon Rh-Subgroups + K
10 Jun 2019 Medical Device Safety Alert: Boston Scientific Cosman TCN Electrodes
31 May 2019 Medical Device Safety Alert: Philips Medical Systems HeartStart MRx Defibrillator/Monitor M3539A AC Power Module
30 May 2019 Medical Device Safety Alert: Roche Tina-quant IgA Gen.2 assay on cobas c701/702
30 May 2019 Medical Device Safety Alert: Medtronic Guardian Connect Continuous Glucose Monitoring (CGM) system
30 May 2019 Medical Device Safety Alert: Bio-Rad ID-DiaCell I-II-III Asia
29 May 2019 Medical Device Safety Alert: Nobel Biocare Healing Abutment Conical Connection RP Ø 3.6 x 5 mm
24 May 2019 Medical Device Safety Alert: Abbott Multiple ARCHITECT Assays
23 May 2019 Medical Device Safety Alert: BioMerieux VIDAS NT-proBNP2
20 May 2019 Medical Device Safety Alert: Continuous glucose monitoring systems (CGMs), insulin pumps, or automated insulin dosing (AID) systems
16 May 2019 Medical Device Safety Alert: Leonhard Lang Defibrillation Electrodes
14 May 2019 Medical Device Safety Alert: SenTec Membrane Changers and their Inserts
10 May 2019 Medical Device Safety Alert: Mindray British standard power cord
10 May 2019 Medical Device Safety Alert: Medtronic Azure and Astra pacemakers, Percepta, Serena and Solara cardiac resynchronization therapy pacemakers (CRT-P)
09 May 2019 Medical Device Safety Alert: Medtronic HeartWare Monitor AC Adapter
06 May 2019 Medical Device Safety Alert: Terumo SOLOPATH Balloon Expandable TransFemoral System and SOLOPATH Re-collapsible Balloon Access System
03 May 2019 Medical Device Safety Alert: Medtronic MAHURKAR and Argyle Acute Hemodialysis Catheters
03 May 2019 Medical Device Safety Alert: Baxter Healthcare Ltd Prismaflex Sets
03 May 2019 Medical Device Safety Alert: Abbott Vascular MitraClip XTR Clip Delivery System
02 May 2019 Medical Device Safety Alert: Beckman Coulter IMMAGE Immunochemistry Systems Immunoglobulin M (IGM) Reagent
26 Apr 2019 Medical Device Safety Alert: Terumo Cardiovascular Systems Terumo Advanced Perfusion System 1 –Electronic Patient Gas System (EPGS) Flowmeter
25 Apr 2019 Medical Device Safety Alert: Cook Medical Kwart Retro-Inject Ureteral Stent Set and Salle Intraoperative Pyeloplasty Stent Set
10 Apr 2019 Medical Device Safety Alert: Previously Owned Test Strips
10 Apr 2019 Medical Device Safety Alert: Cook Medical Pericardiocentesis and Thoracentesis Catheter
29 Mar 2019 Medical Device Safety Alert: Brainlab AG RT Elements Radiation Treatment Planning Software
29 Mar 2019 Medical Device Safety Alert: Nobel Biocare NobelReplace (Tapered Drills, Dense Bone Drills, Screw Taps), Guided Start Drills/Counterbores and Guided Counterbores for NobelReplace, Implant Retrieval Instruments and Abutment Screw Retrieval Instruments
28 Mar 2019 Medical Device Safety Alert: Roche Diagnostics Cobas p 501 / 701 Post-Analytical Units
22 Mar 2019 Medical Device Safety Alert: Roche cobas e 801 module/analytical units and ProCell II M
22 Mar 2019 Medical Device Safety Alert: Edwards Lifesciences Miller Balloon and Fogarty Dilation Atrioseptostomy Catheters
21 Mar 2019 Medical Device Safety Alert: Edwards Lifesciences LLC EV1000 clinical platform
18 Mar 2019 Medical Device Safety Alert: Medtronic Inc. Sherpa 6F Active Catheters
18 Mar 2019 Medical Device Safety Alert: Network Medical Products Ltd Donor Trephine Vacuum Punch 7.50mm
14 Mar 2019 Medical Device Safety Alert: B. Braun Certofix Quattro
11 Mar 2019 Medical Device Safety Alert: Vyaire Medical enFlow Fluid Warming System
07 Mar 2019 Medical Device Safety Alert: BioFire FilmArray Gastrointestinal (GI) Panel
06 Mar 2019 Medical Device Safety Alert: Philips Fetal Spiral Electrode
06 Mar 2019 Medical Device Safety Alert: Extender Cable for Autolith Touch Bipolar Electrohydraulic Lithotripter
01 Mar 2019 Medical Device Safety Alert: Robotically-Assisted Surgical Devices
26 Feb 2019 Medical Device Safety Alert: Cook Medical Inferior Vena Cava Filter Sets
19 Feb 2019 Medical Device Safety Alert: Thermo Fisher Scientific B·R·A·H·M·S uE3 KRYPTOR
14 Feb 2019 Medical Device Safety Alert: Abbott Alinity hq Analyzer
13 Feb 2019 Medical Device Safety Alert: Beckman Coulter Access Thyroglobulin Antibody II (TgAbII)
11 Feb 2019 Medical Device Safety Alert: Penlon Crystal Metal Disposable Laryngoscope Blade - MAC 3
04 Feb 2019 Medical Device Safety Alert: West Pharmaceutical Services Inc. Vial2Bag Direct Connect (DC) 13mm and 20mm, & Vial2Bag
04 Feb 2019 Medical Device Safety Alert: Stryker LIFEPAK 15 Monitor/Defibrillators
31 Jan 2019 Medical Device Safety Alert: Boston Scientific Agile Biliary RX Fully Covered Stent System
30 Jan 2019 Medical Device Safety Alert: Terumo (Philippines) Corporation Terumo Needle and Terumo Needle Neolus
28 Jan 2019 Medical Device Safety Alert: USF Healthcare UNISEPTA FOAM 2 WIPES
25 Jan 2019 Medical Device Safety Alert: Laboratoires Anios WIP'ANIOS PREMIUM and WIP'ANIOS EXCEL
22 Jan 2019 Medical Device Safety Alert: BioMerieux VITEK 2 Identification / Antimicrobial Susceptibility Test Cards
21 Jan 2019 Medical Device Safety Alert: Philips Efficia CM Monitors
18 Jan 2019 Medical Device Safety Alert: Medtronic Dual Chamber Pacemakers
15 Jan 2019 Medical Device Safety Alert: Cellnovo Insulin Infusion System – Bolus Dose Calculator
24 Dec 2018 Medical Device Safety Alert: Roche Diagnostics COBAS INTEGRA 400 plus and cobas c 111 analyzer
21 Dec 2018 Medical Device Safety Alert: Medtronic MiniMed Mio Advance
19 Dec 2018 Medical Device Safety Alert: Ottobock Push valve and Mag valve
12 Dec 2018 Medical Device Safety Alert: Ethicon Endo-Surgery PROXIMATE Hemorrhoidal Circular Stapler
30 Nov 2018 Medical Device Safety Alert: Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer with Software Version 1.07
29 Nov 2018 Medical Device Safety Alert: Arjo Minstrel floor lift
29 Nov 2018 Medical Device Safety Alert: Maquet Heater-Cooler Unit HCU 40
27 Nov 2018 Medical Device Safety Alert: Philips Efficia 3/5 ECG Trunk Cable, AAMI/IEC
16 Nov 2018 Medical Device Safety Alert: Philips Brilliance Computed Tomography Systems
14 Nov 2018 Medical Device Safety Alert: RaySearch Laboratories RayStation 3.5, 4.0, 4.5, 4.7, 5, 6, 7 and 8A
05 Nov 2018 Medical Device Safety Alert: SSI Diagnostica Pneumococcus Factor 7 Antiserum
02 Nov 2018 Medical Device Safety Alert: Boston Scientific Subcutaneous Implantable Cardioverter Defibrillator system's SQ-RX Model 1010 Pulse Generator
26 Oct 2018 Medical Device Safety Alert: Philips Volcano Visions PV .035 Intravascular Ultrasound (IVUS) Catheter
24 Oct 2018 Medical Device Safety Alert: Philips HeartStart FR3 Automated External Defibrillators
19 Oct 2018 Medical Device Safety Alert: Philips Efficia DFM100 Defibrillator/ Monitor
16 Oct 2018 Medical Device Safety Alert: Accuray CyberKnife M6 Treatment Delivery System Robot Wrist Inspection
15 Oct 2018 Medical Device Safety Alert: Medtronic Covidien Parietex Composite Parastomal Mesh
09 Oct 2018 Medical Device Safety Alert: Drager WaterLock 2 and WaterLock 2 Infinity ID
04 Oct 2018 Medical Device Safety Alert: Abbott ARCHITECT HAVAb-IgG Reagent Kit, ARCHITECT HAVAb-IgM Reagent Kit and Alinity i HAVAb IgG Reagent Kit
03 Oct 2018 Medical Device Safety Alert: Baxter Healthcare Corporation EXACTAMIX EVA Bags
02 Oct 2018 Medical Device Safety Alert: Abbott Diagnostic Instrument Manager
28 Sep 2018 Medical Device Safety Alert: RayStation 4.5, 4.7, 5, 6 and 7
28 Sep 2018 Medical Device Safety Alert: GE Medical Systems Information Technologies B20/B20i/B40/B40i, and B105/B125 Patient Monitors
21 Sep 2018 Medical Device Safety Alert: Abbott Alinity i Processing Module
21 Sep 2018 Medical Device Safety Alert: Richard Wolf GmbH TEXAS Bronchoscope Tube
14 Sep 2018 Medical Device Safety Alert: CooperSurgical SINGLE-USE CPO-6 COLPO-PNEUMO OCCLUDER
13 Sep 2018 Medical Device Safety Alert: Boston Scientific Latitude Programmer Model 3300
10 Sep 2018 Medical Device Safety Alert: Medtronic O-arm 1000 Imaging Systems
04 Sep 2018 Medical Device Safety Alert: Abbott Alere NT-proBNP for ARCHITECT Controls
04 Sep 2018 Medical Device Safety Alert: Abbott ARCHITECT ICT Module
31 Aug 2018 Medical Device Safety Alert: Medtronic HeartWare HVAD System Controller/ Controller Kits
29 Aug 2018 Medical Device Safety Alert: Alcon CyPass Micro-Stent
29 Aug 2018 Medical Device Safety Alert: Beckman Coulter Lipase, Uric acid, HDL-Cholesterol, Enzymatic Creatinine assays
29 Aug 2018 Medical Device Safety Alert: Vyaire Medical Tri-Flo Subglottic Suction System
28 Aug 2018 Medical Device Safety Alert: Accuray CyberKnife Treatment Delivery System
24 Aug 2018 Medical Device Safety Alert: Boston Scientific Accolade family pacemakers
24 Aug 2018 Medical Device Safety Alert: BioMerieux VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards
23 Aug 2018 Medical Device Safety Alert: William Cook Europe Zenith Alpha Thoracic Endovascular Graft
22 Aug 2018 Medical Device Safety Alert: Eurogine S.L. Intrauterine Devices (Updates)
19 Aug 2018 Medical Device Safety Alert: Sterile Products from NuVision Pharmacy
10 Aug 2018 Medical Device Safety Alert: Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System and UniCel DxH 600 Coulter Cellular Analysis System
09 Aug 2018 Medical Device Safety Alert: Bausch & Lomb Stellaris Elite Single Port Vitrectomy Cutters
07 Aug 2018 Medical Device Safety Alert: Energy-Based Devices
07 Aug 2018 Medical Device Safety Alert: Bausch & Lomb Stellaris Elite Single Port Vitrectomy Cutters
06 Aug 2018 Medical Device Safety Alert: Medtronic Capnostream 20 and Capnostream 20p Bedside Patient Monitors
31 Jul 2018 Medical Device Safety Alert: BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit
20 Jul 2018 Medical Device Safety Alert: Durex polyisoprene (PI) synthetic latex condoms
18 Jul 2018 Medical Device Safety Alert: Synthes Adapter for Colibri and small Adapter for Colibri II and Small Battery Drive and Small Battery Drive II
18 Jul 2018 Medical Device Safety Alert: Brilliance 64, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenuity Core128, Ingenuity CT, Brilliance CT BigBore and IQon Spectral CT
18 Jul 2018 Medical Device Safety Alert: bioMerieux VIDAS CA 15-3
18 Jul 2018 Medical Device Safety Alert: Intragastric balloon systems
12 Jul 2018 Medical Device Safety Alert: bioMerieux BACT/ALERT VIRTUO Systems
06 Jul 2018 Medical Device Safety Alert: Roche Diagnostics cobas p 612 pre-analytical system (LCP1)
05 Jul 2018 Medical Device Safety Alert: ConvaTec, Suction Catheter w/Funnel
03 Jul 2018 Medical Device Safety Alert: RaySearch Laboratories AB, RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A
28 Jun 2018 Medical Device Safety Alert: Medtronic EnTrust VR/DRI AT Implantable Cardioverter Defibrillators
28 Jun 2018 Medical Device Safety Alert: Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan Pacemakers
25 Jun 2018 Medical Device Safety Alert: LivaNova Perceval Sutureless Heart Valve
25 Jun 2018 Medical Device Safety Alert: Boston Scientific Maestro 4000 Cardiac Ablation System Optional Footswitch Accessory
22 Jun 2018 Medical Device Safety Alert: Medtronic Single Chamber Temporary External Pacemaker 53401
22 Jun 2018 Medical Device Safety Alert: Guangzhou Sunray Maternal and Fetal Monitor (Model: SRF618X9) (STAN S41)
21 Jun 2018 Medical Device Safety Alert: VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200 and OTV-S300
15 Jun 2018 Medical Device Safety Alert: Medtronic Model 53912 Reusable External Pulse Generator Extension Cable and Model 53912A EPG Extension Cable
15 Jun 2018 Medical Device Safety Alert: Mandible Distractor, Monoaxial and Proximal Foot Plate
14 Jun 2018 Medical Device Safety Alert: Terumo Heater-Cooler Devices
13 Jun 2018 Medical Device Safety Alert: B. Braun Surgical, S.A Safil and Novosyn
13 Jun 2018 Medical Device Safety Alert: Stryker Neurovascular Synchro 2
11 Jun 2018 Medical Device Safety Alert: RaySearch Laboratories AB, RayStation 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5, 6, 7
29 May 2018 Medical Device Safety Alert: DePuy Synthes CORAIL AMT Neck Trials Surgical Instruments
23 May 2018 Medical Device Safety Alert: Thermo Scientific Remel Salmonella paratyphi A-H Stained Suspension
23 May 2018 Medical Device Safety Alert: ArjoHuntleigh Akron Tilt Table
21 May 2018 Medical Device Safety Alert: Radiometer ABL90 FLEX
21 May 2018 Medical Device Safety Alert: Radiometer NT-proBNP Test Kits
16 May 2018 Medical Device Safety Alert: Pace Medical temporary pacemakers and pacing system analysers
10 May 2018 Medical Device Safety Alert: Baxter Healthcare EXACTAMIX Inlets
09 May 2018 Medical Device Safety Alert: Medset CM Breast Pump Kit
09 May 2018 Medical Device Safety Alert: Neurovascular Stents Used for Stent-Assisted Coiling
07 May 2018 Medical Device Safety Alert: Baxter Healthcare Prismaflex Control Unit
07 May 2018 Medical Device Safety Alert: HARMONIC ACE+ Shears with Adaptive Tissue Technology (23cm and 36cm)
04 May 2018 Medical Device Safety Alert: Medtronic HeartWare HVAD Systems
02 May 2018 Medical Device Safety Alert: Roche Diagnostics MagNA Pure 24 System
02 May 2018 Medical Device Safety Alert: B. Braun Hospicare Ltd Askina Gel and Calgitrol Paste
26 Apr 2018 Medical Device Safety Alert: Magnetic Resonance-guided Laser Interstitial Thermal Therapy
25 Apr 2018 Medical Device Safety Alert: Roche Diagnostics Elecsys Vitamin D total II
23 Apr 2018 Medical Device Safety Alert: RaySearch Laboratories AB RayStation 6 & 7
17 Apr 2018 Medical Device Safety Alert: Percutaneous Radiofrequency Ablation Catheter
16 Apr 2018 Medical Device Safety Alert: Philips Ingenuity Core
13 Apr 2018 Medical Device Safety Alert: Fresenius Medical Care Australia - Tubing set, dialysis/haemodialysis (4008 HD Bloodlines)
13 Apr 2018 Medical Device Safety Alert: Teleflex Medical Hudson RCI One-Way Valve with Capped Monitoring Port
12 Apr 2018 Medical Device Safety Alert: Entrada Needle (Accessory Infinion CX lead)
12 Apr 2018 Medical Device Safety Alert: HeartMate 3 Left Ventricular Assist System
08 Apr 2018 Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Immunodiagnostic Products NT-proBNP Calibrators, VITROS Immunodiagnostic Products NT-proBNP Reagent Packs
04 Apr 2018 Medical Device Safety Alert: Synthes GmbH Sciatic Nerve Retractors
28 Mar 2018 Medical Device Safety Alert: Synthes GmbH Epoca Stem Extractors and Connection Screws
23 Mar 2018 Medical Device Safety Alert: Magellan Diagnostics LeadCare Testing Systems (Update)
23 Mar 2018 Medical Device Safety Alert: Becton Dickson BD Vacutainer EDTA tubes and BD Vacutainer Lithium Heparin Green Top Tubes
23 Mar 2018 Medical Device Safety Alert: FilmArray Blood Culture Identification Panel used with Becton Dickinson BACTEC Blood Culture Bottle
19 Mar 2018 Medical Device Safety Alert: PTS Diagnostics PTS Panels CHOL+GLU test strips
19 Mar 2018 Medical Device Safety Alert: Nobel Biocare 17° Multi-Unit Abutment CC NP 2.5mm
15 Mar 2018 Medical Device Safety Alert: Cook Medical StoneBreaker Pneumatic Lithotripter and associated accessories
14 Mar 2018 Medical Device Safety Alert: Philips HeartStart FRx, HeartStart Home, and HeartStart OnSite automated external defibrillators
14 Mar 2018 Medical Device Safety Alert: Neurovascular Embolization Coils
09 Mar 2018 Medical Device Safety Alert: BioMérieux, VIDAS FSH
08 Mar 2018 Medical Device Safety Alert: Medtronic Puritan Bennett 980 Universal Ventilator System – TGA's suspension revoked and new suspension in place
08 Mar 2018 Medical Device Safety Alert: Rite Aid Mini Digital Temple Touch Thermometer
06 Mar 2018 Medical Device Safety Alert: Medtronic Endurant/ Endurant II 23mm and 25mm Bifurcated Stent Graft Systems
05 Mar 2018 Medical Device Safety Alert: Merit 1mL Medallion Syringes
01 Mar 2018 Medical Device Safety Alert: Dräger Fabius Anaesthesia Machine
01 Mar 2018 Medical Device Safety Alert: ETHICON Generator Gen11
28 Feb 2018 Medical Device Safety Alert: Eurogine S.L. Intrauterine Devices
28 Feb 2018 Medical Device Safety Alert: Medtronic Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators
28 Feb 2018 Medical Device Safety Alert: SynCardia Freedom Driver System
26 Feb 2018 Medical Device Safety Alert: Medline ACME Monaco Guidewire
23 Feb 2018 Medical Device Safety Alert: ArjoHuntleigh Quick connect scales used with Maxi Sky 2 ceiling lifts
23 Feb 2018 Medical Device Safety Alert: Jolife AB LUCAS 2 Chest Compression System
22 Feb 2018 Medical Device Safety Alert: Dornier MedTech Dornier Gemini lithotripter
14 Feb 2018 Medical Device Safety Alert: Boston Scientific Capio Suture Capturing Devices and Pelvic Floor Kits
14 Feb 2018 Medical Device Safety Alert: Aesculap AG Doyen-Collin Mouth Gag 120mm
11 Feb 2018 Medical Device Safety Alert: GE Healthcare Infinia and Infinia Hawkeye, Millennium VG, VG Hawkeye and VariCam Nuclear Medicine systems
09 Feb 2018 Medical Device Safety Alert: Brainlab ExacTrac Patient Positioning System: Additional instructions and warnings for beam authorization by ExacTrac via ADI
06 Feb 2018 Medical Device Safety Alert: Boston Scientific, RF 3000 device
06 Feb 2018 Medical Device Safety Alert: Therakos, Inc. CELLEX Photopheresis System
31 Jan 2018 Medical Device Safety Alert: Beckman Coulter Automate 2550 and 1250, Aliquotter Tip Present Sensor
31 Jan 2018 Medical Device Safety Alert: Vyaire Medical Air Life Humidification Chamber & Heated Breathing Circuit Kits
30 Jan 2018 Medical Device Safety Alert: Schiller Medical, Monitor/ Defibrillator DEFIGARD Touch7
18 Jan 2018 Medical Device Safety Alert: Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents
18 Jan 2018 Medical Device Safety Alert: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
16 Jan 2018 Medical Device Safety Alert: Menicon MeniCare Soft 70ML
15 Jan 2018 Medical Device Safety Alert: Pneumothorax Events associated with Feeding Tube Placement Systems
12 Jan 2018 Medical Device Safety Alert: Edwards LifeSciences Certitude Delivery Systems
09 Jan 2018 Medical Device Safety Alert: Physio-Control, LIFEPAK 20e Defibrillator/Monitor
09 Jan 2018 Medical Device Safety Alert: Intersurgical Ltd BVM (Bag-Valve-Mask) Manual Resuscitation Systems
04 Jan 2018 Medical Device Safety Alert: Sterilmed Reprocessed Agilis Steerable Introducer Sheath
03 Jan 2018 Medical Device Safety Alert: Beckman Coulter, Synchron Enzyme Validator
03 Jan 2018 Medical Device Safety Alert: Baxter Healthcare MARS Kit Gambro, Type 1116/1-X-MARS
22 Dec 2017 Medical Device Safety Alert: Boston Scientific pacemakers and Cardiac Resynchronization Therapy pacemakers - Minute Ventilation Signal Oversensing
22 Dec 2017 Medical Device Safety Alert: Boston Scientific Cardiac Resynchronization Therapy (CRT) pacemakers and defibrillators - CRT Positive Left Ventricular Offset
22 Dec 2017 Medical Device Safety Alert: Boston Scientific SpyScope DS Access and Delivery Catheter
18 Dec 2017 Medical Device Safety Alert: Greiner Bio-One MiniCollect Complete 1ml 9NC Coagulation Sodium Citrate 3.2%
14 Dec 2017 Medical Device Safety Alert: Edwards LifeSciences ClearSight Heart Reference Sensor
05 Dec 2017 Medical Device Safety Alert: Cook Medical Vital-Port Vascular Access Systems
30 Nov 2017 Medical Device Safety Alert: Urogynaecological Surgical Mesh Implants
29 Nov 2017 Medical Device Safety Alert: Biotin may interfere with lab tests
24 Nov 2017 Medical Device Safety Alert: RaySearch Laboratories RayStation
21 Nov 2017 Medical Device Safety Alert: PFM Medical Nit-Occlud Implantation Sheath
15 Nov 2017 Medical Device Safety Alert: Injectable Silicone for Body Contouring and Enhancement
03 Nov 2017 Medical Device Safety Alert: Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes
01 Nov 2017 Medical Device Safety Alert: Abbott Vascular Absorb GT1 Bioresorbable Vascular Scaffold (BVS)
27 Oct 2017 Medical Device Safety Alert: Fisher & Paykel Healthcare Single Use Home Ventilation Breathing Circuit
27 Oct 2017 Medical Device Safety Alert: Stryker GmbH rHead Radial Head and Uni-Elbow System
25 Oct 2017 Medical Device Safety Alert: Hospira MedNet Medication Management Suite
23 Oct 2017 Medical Device Safety Alert: Johnson & Johnson ACUVUE soft contact lenses
13 Oct 2017 Medical Device Safety Alert: GE Healthcare Carestation 620, Carestation 650, and Carestation 650c Anaesthesia Systems
12 Oct 2017 Medical Device Safety Alert: Medtronic FlexCath Advance Steerable Sheath
10 Oct 2017 Medical Device Safety Alert: MAQUET SERVO-air
10 Oct 2017 Medical Device Safety Alert: Boston Scientific RESONATE, VIGILANT X4, PERCIVA, and MOMENTUM CRT-D/ICD
03 Oct 2017 Field Safety Notice: Dräger Dual Hemo MCable pod used with the Infinity Acute Care System (IACS) Monitoring Solution
28 Sep 2017 Medical Device Safety Alert: Endovascular Graft Systems
28 Sep 2017 Medical Device Safety Alert: W. L. Gore & Associates Inc Conformable TAG Thoracic Endoprosthesis
26 Sep 2017 Medical Device Safety Alert: Boston Scientific INGEVITY MRI active fixation pacing leads
20 Sep 2017 Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Chemistry Products DAT Performance Verifiers
19 Sep 2017 Medical Device Safety Alert: Medtronic Puritan Bennett 980 Universal Ventilator System
19 Sep 2017 Medical Device Safety Alert: Surgical Innovations Ltd 5/10/12mm Armoured Swing-top
15 Sep 2017 Medical Device Safety Alert: DePuy DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants
15 Sep 2017 Medical Device Safety Alert: Medtronic SynchroMed II Implantable Drug Infusion Pump
14 Sep 2017 Medical Device Safety Alert: OriGen Biomedical VV28F Reinforced Dual Lumen ECMO Catheters
12 Sep 2017 DH notified of recall of specific lots of MiniMed Infusion Sets
07 Sep 2017 Medical Device Safety Alert: Bio-Rad DiaMed Q.C. System
04 Sep 2017 Medical Device Safety Alert: Bio-Rad ID-DiaCell I-II-III Asia
01 Sep 2017 Medical Device Safety Alert: Bi-leaflet Mechanical Heart Valves
31 Aug 2017 Medical Device Safety Alert: Forced Air Thermal Regulating Systems
30 Aug 2017 Medical Device Safety Alert: Beckman Coulter IRISpec CA/CB/CC control
22 Aug 2017 Medical Device Safety Alert: Terumo FemoSeal Vascular Closure Systems
22 Aug 2017 Medical Device Safety Alert: Intersurgical 22mm Flextube Transport Breathing Systems with non-rebreathing valve
15 Aug 2017 Medical Device Safety Alert: Synthes GmbH Locking Compression Plate Drill Sleeve 1.5 f/Drill Bit ø1.1mm
08 Aug 2017 Medical Device Safety Alert: Olympus Cystoscopy Bridges and Working Inserts
02 Aug 2017 Medical Device Safety Alert: Smiths Medical Medfusion Syringe Pump Model Series 3500 and 4000
28 Jul 2017 Medical Device Safety Alert: Gadolinium-based contrast agents for MRI scans
26 Jul 2017 Medical Device Safety Alert: BD Alaris System PC unit Model 8015
26 Jul 2017 Medical Device Safety Alert: BD Alaris Pump module model 8100
24 Jul 2017 Medical Device Safety Alert: Penumbra 3D Revascularization Device
20 Jul 2017 Medical Device Safety Alert: Roche Diagnostics cobas c 501 module and cobas c 502 module
14 Jul 2017 Medical Device Safety Alert: Medtronic Euphora Semi-Compliant Rapid Exchange Balloon Dilatation Catheter
12 Jul 2017 Medical Device Safety Alert: BioMérieux Mueller Hinton E Agar
11 Jul 2017 Medical Device Safety Alert: HORIBA ABX SAS Yumizen H500 CT (Closed Tube) (Version 2.1.0 or lower)
11 Jul 2017 Medical Device Safety Alert: Cook Medical Fusion Pushing Catheter
07 Jul 2017 Medical Device Safety Alert: Boston Scientific Cosman Medical Nitinol RF (TCN) Reusable Electrodes
07 Jul 2017 Medical Device Safety Alert: ATAR Extension Cable
06 Jul 2017 Medical Device Safety Alert: Roche Diagnostics immunochemistry modules E170, cobas e 601 and cobas e 602
03 Jul 2017 DH notified of batch recall of NovoPen Echo and NovoPen 5
03 Jul 2017 Medical Device Safety Alert: Boston Scientific Emblem S-ICD System
30 Jun 2017 Medical Device Safety Alert: All metal-on-metal (MoM) hip replacements – updated advice for follow-up of patients
29 Jun 2017 Medical Device Safety Alert: Roche Diagnostics cobas e 411 analyzer
29 Jun 2017 Medical Device Safety Alert: Beckman Coulter Synchron Systems Salicylate Reagent
28 Jun 2017 Medical Device Safety Alert: Novadaq Technologies Inc. SPY-PHI Drape
27 Jun 2017 Medical Device Safety Alert: ICU Medical Hospira Plum 360 Infusion System
27 Jun 2017 Medical Device Safety Alert: Beckman Coulter PK7300 Automated Microplate System
21 Jun 2017 Medical Device Safety Alert: Philips Medical Systems HeartStart MRX Defibrillator/Monitor M3535A and M3536A
20 Jun 2017 Medical Device Safety Alert: Maquet System CS 100, CS100i and CS 300 Intra-Aortic Balloon Pumps
20 Jun 2017 Medical Device Safety Alert: Boston Scientific Encore 26 Inflation Device Single Pack
12 Jun 2017 Medical Device Safety Alert: Hamilton Medical AG IntelliCuff Standalone
07 Jun 2017 Medical Device Safety Alert: Beckman Coulter AutoMate 2500 Family
07 Jun 2017 Medical Device Safety Alert: Trinity Biotech Premier Buffer B Reagent
05 Jun 2017 Medical Device Safety Alert: Boston Scientific Extractor Pro RX-S
05 Jun 2017 Medical Device Safety Alert: Creganna Tactx Medical Zurpaz Steerable Sheath 8.5F Asymmetric and Symmetric Curves
02 Jun 2017 Medical Device Safety Alert: Boston Scientific Fractional Flow Reserve (FFR) Link
31 May 2017 Medical Device Safety Alert: Zimmer Biomet Implantable Spinal Fusion Stimulators
29 May 2017 Medical Device Safety Alert: Beckman Coulter DxH 500 Hematology Analyser
24 May 2017 Medical Device Safety Alert: Terumo Corporation Radifocus Introducer II, Radifocus Introducer II M Coat and Glidesheath Slender
19 May 2017 Medical Device Safety Alert: BioMérieux VITEK 2 Gram-Negative AST cards
19 May 2017 Medical Device Safety Alert: Medtronic Endo Peanut 5 mm Device
18 May 2017 Medical Device Safety Alert: Magellan Diagnostics LeadCare Testing Systems
16 May 2017 Medical Device Safety Alert: Meditech Ultrasound Gel
15 May 2017 Medical Device Safety Alert: Medtronic KYPHON and KYPHON EXPRESS Directional Bone Void Filler
15 May 2017 Medical Device Safety Alert: Beckman Coulter Access Total T3, Access Thyroglobulin, Access Free T4, Access GI Monitor
05 May 2017 Medical Device Safety Alert: Hamilton Medical AG Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit
05 May 2017 Medical Device Safety Alert: Alere SD BIOLINE HIV Ag/Ab Combo
04 May 2017 Medical Device Safety Alert: Medtronic NavLock Tracker
04 May 2017 Medical Device Safety Alert: ReFlow Medical Inc Wingman35 Crossing Catheters
25 Apr 2017 Medical Device Safety Alert: Cook Medical Stamey Needle, Clarke-Reich Laparoscopic Knot Pusher, Endoscopic Introducer/Extractor, Pereyra Ligature Carrier '75, and Pereyra-Raz Ligature Carrier
24 Apr 2017 Medical Device Safety Alert: BioMérieux VITEK 2 Identification / Antimicrobial Susceptibility Test Cards
24 Apr 2017 Medical Device Safety Alert: Abbott ARCHITECT SHBG Reagents
24 Apr 2017 Medical Device Safety Alert: Beckman Coulter Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents
21 Apr 2017 Medical Device Safety Alert: Abbott Medical Optics Vitrectomy Cutter
19 Apr 2017 Medical Device Safety Alert: Abbott Medical Optics Healon Ophthalmic Viscoelastic Devices
18 Apr 2017 Medical Device Safety Alert: Boston Scientific JETSTREAM Atherectomy Catheters
18 Apr 2017 Medical Device Safety Alert: Beckman Coulter Access BR Monitor
12 Apr 2017 Medical Device Safety Alert: Risk of Entrapment of Patients in Hospital Beds
11 Apr 2017 Medical Device Safety Alert: Iris International iChemVELOCITY Urine Chemistry Systems
31 Mar 2017 Medical Device Safety Alert: Merit 7F Prelude Short Sheath Introducers
30 Mar 2017 Medical Device Safety Alert: Intersurgical Ltd Solus Flexible Wire-reinforced Laryngeal Mask Airways
28 Mar 2017 Medical Device Safety Alert: ROSA Brain 3.0.0 Robotic Surgical Assistant
23 Mar 2017 Medical Device Safety Alert: Hill-Rom Centuris P750 Beds
22 Mar 2017 Medical Device Safety Alert: William Cook Europe Zenith Alpha Thoracic Endovascular Graft
22 Mar 2017 Medical Device Safety Alert: Abbott Vascular NC Trek RX Coronary Dilatation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter
20 Mar 2017 Medical Device Safety Alert: BÜHLMANN Laboratories AG CALEX Cap Device
20 Mar 2017 Medical Device Safety Alert: 3M Universal Electrosurgical Pads
17 Mar 2017 Medical Device Safety Alert: Philips Medical Systems HeartStart MRX Defibrillator/Monitor M3536A and M3535A
14 Mar 2017 Medical Device Safety Alert: Menicon soft 72 soft hydrophilic contact lenses
13 Mar 2017 Medical Device Safety Alert: Paul Hartmann Vivano Med Foam Abdominal Kit st P3
10 Mar 2017 Medical Device Safety Alert: Organ Recovery Systems, Inc SPS-1 Static Preservation Solution
10 Mar 2017 Medical Device Safety Alert: Hitachi High Technologies Corporation Sample Probe Connectors
09 Mar 2017 Medical Device Safety Alert: Balloon angioplasty devices to treat autonomic dysfunction
09 Mar 2017 Medical Device Safety Alert: Biomérieux NucliSENS Lysis Buffer
09 Mar 2017 Medical Device Safety Alert: BD Pharmingen, Horizon and Phosflow
08 Mar 2017 Medical Device Safety Alert: Medtronic Covidien Curity Eye Pad, Curity Eye Pad Oval, Curity Wet Dressing, Kerlix Super Sponge Saline Dressing, Curity Sodium Chloride Dressing and Curity Saline Dressing
08 Mar 2017 Medical Device Safety Alert: Cook Medical Cook Bush SL Ureteral Illuminating Catheter Set and Cook Bush DL Ureteral Illuminating Catheter Set
06 Mar 2017 Medical Device Safety Alert: Baxter Healthcare Artis Dialysis System
01 Mar 2017 Medical Device Safety Alert: Beckman Coulter IMMAGE Immunochemistry Systems Cuvette Sectors
28 Feb 2017 Medical Device Safety Alert: Roche Diagnostics cobas 8000 Operator's Manual version 5.0
28 Feb 2017 Medical Device Safety Alert: Trinity Biotech Premier Buffer A and B Reagent
24 Feb 2017 Medical Device Safety Alert: Randox Laboratories Myoglobin Assay in Liquid Cardiac Control Level 1, 2 and 3
23 Feb 2017 Medical Device Safety Alert: Baxter Healthcare Prismaflex Control Unit
21 Feb 2017 Medical Device Safety Alert: Battery pack for MEDUCORE Easy
15 Feb 2017 Medical Device Safety Alert: BioMérieux VITEK 2 AST-P586 Test Kit 20 Cards
15 Feb 2017 Medical Device Safety Alert: Coris BioConcept RESIST-3 O.K.N. K-set
14 Feb 2017 Medical Device Safety Alert: DiaMed Test Cells for Red Cell Antibody Screening
10 Feb 2017 Medical Device Safety Alert: Physio-Control LIFEPAK 15 Monitor/Defibrillator
09 Feb 2017 Medical Device Safety Alert: Cook Medical Check-Flo Blue Valve Devices
08 Feb 2017 Medical Device Safety Alert: Boston Scientific AngioJet Ultra 5000A Console Foot Switch
08 Feb 2017 Medical Device Safety Alert: Schiller Medical CARDIOVIT AT-102 Plus
08 Feb 2017 Medical Device Safety Alert: Roche Diagnostics Elecsys Anti-HAV
06 Feb 2017 Medical Device Safety Alert: Schiller Medical SAS FRED easy
06 Feb 2017 Medical Device Safety Alert: Brainlab Offset Cup Impactor Universal
06 Feb 2017 Medical Device Safety Alert: Olympus ENDOEYE HD II Video Telescope
02 Feb 2017 Medical Device Safety Alert: Kerr Corporation PREMISA Unidose Refills - A3.5
27 Jan 2017 Medical Device Safety Alert: ETHICON PERMA-HAND Silk Suture
26 Jan 2017 Medical Device Safety Alert: Bayer Medical Care Medrad Spectris Solaris EP MR Injection System
25 Jan 2017 Medical Device Safety Alert: BioMerieux ETEST XM256 (Cefuroxime) FOAM and SPB
20 Jan 2017 Safety alert on automated external defibrillator LIFEPAK 1000
18 Jan 2017 Medical Device Safety Alert: Boston Scientific Emblem S-ICD Systems
18 Jan 2017 Medical Device Safety Alert: Boston Scientific INLIVEN Cardiac Resynchronization Therapy Pacemaker
16 Jan 2017 Medical Device Safety Alert: Physio-Control LIFEPAK 1000 Defibrillators
11 Jan 2017 Medical Device Safety Alert: BD Eclipse Needle
10 Jan 2017 Medical Device Safety Alert: DePuy Synthes Radial Head Prosthesis System
10 Jan 2017 Medical Device Safety Alert: Advanced Sterilization Products STERRAD NX System
10 Jan 2017 Medical Device Safety Alert: St. Jude Medical Merlin@home Transmitter
09 Jan 2017 Medical Device Safety Alert: BioMerieux ETEST Foam packagings of Ceftazidime TZ256, Ciprofloxacin CI 32, Vancomycin VA 256, Benzyl Penicillin PG256, Imipenem IP32, Gentamicin GM256, Cephalotin CE256, Doripenem DOR32 and Tobramycin TM256, BLISTER packaging
09 Jan 2017 Medical Device Safety Alert: Olympus Uretero-reno Videoscopes and Uretero-reno Fiberscopes
04 Jan 2017 Medical Device Safety Alert: nal von minden NADAL hCG Pregnancy rapid test
28 Dec 2016 Medical Device Safety Alert: InBios International ZIKV Detect IgM Capture ELISA
23 Dec 2016 Medical Device Safety Alert: Alaris Syringe Pumps
23 Dec 2016 Medical Device Safety Alert: Boston Scientific Imager II Angiographic Catheters
23 Dec 2016 Medical Device Safety Alert: Trinity Biotech GLUCOSE-6 PHOSPHATE DEHYDROGENASE (G-6-PDH)
23 Dec 2016 Medical Device Safety Alert: Association between Breast Implants and Anaplastic Large Cell Lymphoma (ALCL)
22 Dec 2016 Medical Device Safety Alert: Boston Scientific Express LD Biliary Stent
21 Dec 2016 Medical Device Safety Alert: Fresenius Medical Care Sleep-Safe Sets
21 Dec 2016 Medical Device Safety Alert: Boston Scientific Imager II Angiographic Catheter
20 Dec 2016 Medical Device Safety Alert: Medtronic Amplia MRI CRT-D SureScan and Claria MRI CRT-D SureScan
19 Dec 2016 Medical Device Safety Alert: FDA Bans Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove
16 Dec 2016 Medical Device Safety Alert: BioMerieux ETEST COLISTIN CO256 WW
16 Dec 2016 Medical Device Safety Alert: Synthes GmbH Impactor for PFNA Blade
14 Dec 2016 Medical Device Safety Alert: Brainlab iPlan RT, iPlan RT Dose (all versions) and BrainSCAN (discontinued)
12 Dec 2016 Medical Device Safety Alert: Draeger Oxylog Transport Ventilators
12 Dec 2016 Medical Device Safety Alert: Centurion Multi-Med Single Lumen Catheters
09 Dec 2016 Medical Device Safety Alert: Boston Scientific Percuflex Urinary Diversion Stent 6Fr and 7Fr
09 Dec 2016 Medical Device Safety Alert: Boston Scientific INGEVITY MRI endocardial pacing leads
06 Dec 2016 Medical Device Safety Alert: Ortho Clinical Diagnostics ORTHO VISION Analyzer and ORTHO VISION Max Analyzer
02 Dec 2016 Medical Device Safety Alert: Abbott ARCHITECT Active-B12 Reagent Kit
30 Nov 2016 Medical Device Safety Alert: ASR XL total hip replacements
29 Nov 2016 Medical Device Safety Alert: Roche cobas b 123 - Neonatal Bilirubin Results with Software SW4.7
28 Nov 2016 Medical Device Safety Alert: Bausch & Lomb Algerbrush- II and its accessories
23 Nov 2016 Medical Device Safety Alert: SentreHEART FindrWIRZ Guidewire System
15 Nov 2016 Safety alert on contamination of heater-cooler device use in cardiothoracic surgery
08 Nov 2016 Medical Device Safety Alert: Leonhard Lang Defibrillation electrode SCHILLER DF87C and Defibrillation electrode SCHILLER DF56C
07 Nov 2016 Medical Device Safety Alert: Teleflex LMA MAD Nasal Intranasal Mucosal Atomisation Device
02 Nov 2016 Medical Device Safety Alert: Boston Scientific Lotus Edge Valve System
31 Oct 2016 Medical Device Safety Alert: GE Healthcare XR 6000 systems
27 Oct 2016 Medical Device Safety Alert: SynCardia Systems Temporary Total Artificial Heart Companion 2 Driver System and Freedom Driver System
25 Oct 2016 Medical Device Safety Alert: Codonics Virtua / Virtua XR Medical Disc Publisher
25 Oct 2016 Medical Device Safety Alert: Depuy Synthes FACET WEDGE System
13 Oct 2016 Medical Device Safety Alert: Oscor Adelante Breezeway 8F and 10F
13 Oct 2016 Medical Device Safety Alert: Abbott ARCHITECT Lactic Acid
11 Oct 2016 Medical Device Safety Alert: Medtronic Pipeline Embolization Device (Pipeline Classic), Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire, UltraFlow HPC Flow Directed Microcatheter and Marathon Flow Directed Microcatheter
11 Oct 2016 Medical Device Safety Alert: St. Jude Medical Implantable devices- Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra
06 Oct 2016 Medical Device Safety Alert: Boston Scientific Interject Injection Therapy Needle Catheter & Mustang PTA Balloon Peripheral Angioplasty Catheter
28 Sep 2016 Medical Device Safety Alert: Medela UK (Type G) detachable power plugs of three models of Medela breast pump
21 Sep 2016 Medical Device Safety Alert: Vascular Solutions Twin-Pass, Twin-Pass RX and Twin-Pass .023" Catheters
20 Sep 2016 Medical Device Safety Alert: Leonhard Lang Defibrillation Electrode SKINTACT DF29N
08 Sep 2016 Medical Device Safety Alert: Ovarian cancer screening test
06 Sep 2016 Medical Device Safety Alert: BioMerieux Campylosel agar
02 Sep 2016 Medical Device Safety Alert: Abbott Medical Optics TECNIS 1-Piece Intraocular Lenses
02 Sep 2016 Medical Device Safety Alert: Boston Scientific HANAROSTENT esophagus cover
30 Aug 2016 Medical Device Safety Alert: Boston Scientific Neuromodulation Devices
26 Aug 2016 Medical Device Safety Alert: Programmable Syringe Pumps
26 Aug 2016 Medical Device Safety Alert: Sage CHG Cloth Product
18 Aug 2016 Medical Device Safety Alert: BioMerieux Muller Hinton 2 agar + 5% sheep blood
17 Aug 2016 Medical Device Safety Alert: Beckman Coulter UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
12 Aug 2016 Medical Device Safety Alert: HeartWare HVAD Pumps
12 Aug 2016 Medical Device Safety Alert: Terumo Misago Peripheral Self-Expanding Stent System
11 Aug 2016 Medical Device Safety Alert: Beckman Coulter UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
10 Aug 2016 Medical Device Safety Alert: BioMerieux VIDAS TOXO Competition Kit
04 Aug 2016 Medical Device Safety Alert: Medtronic EnVeo R Delivery Catheter System
04 Aug 2016 Medical Device Safety Alert: Boston Scientific Lotus Valve System
02 Aug 2016 Medical Device Safety Alert: BioMerieux Etest COLISTIN CO256 WW
27 Jul 2016 Medical Device Safety Alert: Alere TestPack + Plus with OBC hCG Urine
26 Jul 2016 Medical Device Safety Alert: Inferior vena cava filters
25 Jul 2016 Medical Device Safety Alert: Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Angiodynamics Soft Vu Omni Flush Angiographic Catheter
25 Jul 2016 Medical Device Safety Alert: Invacare Precise RX Pediatric Flowmeter
25 Jul 2016 Medical Device Safety Alert: Trinity Biotech Captia Malaria EIA Kit
20 Jul 2016 Medical Device Safety Alert: TRUEtrack and TRUEtest Blood Glucose Test Strips
19 Jul 2016 Medical Device Safety Alert: Roche Accu-Chek Performa Nano
18 Jul 2016 Medical Device Safety Alert: Biomérieux Magnetic Silica (MagSIL) used in NucliSENS easyMAG nucleic acid extraction system
07 Jul 2016 Medical Device Safety Alert: Cook Medical Roadrunner Uniglide Hydrophilic Wire Guide
07 Jul 2016 Medical Device Safety Alert: Beckman Coulter UniCel DxC Synchron Systems No Foam Reagent
06 Jul 2016 Medical Device Safety Alert: Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators
24 Jun 2016 Medical Device Safety Alert: Depuy Synthes Trochanteric Fixation Nail Advanced (TFNA) guide sleeve, yellow
24 Jun 2016 Medical Device Safety Alert: Medtronic Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors
21 Jun 2016 Medical Device Safety Alert: Lohmann & Rauscher Metalline wound, drainage, tracheo dressings
20 Jun 2016 Medical Device Safety Alert: INEX Filling Cannula
17 Jun 2016 Medical Device Safety Alert: Maquet SERVO-i/s ventilator systems with software version 8.00.00
16 Jun 2016 Medical Device Safety Alert: Beckman Coulter Access Free T3 Reagent Kit
06 Jun 2016 Medical Device Safety Alert: Theraclion ECHOPULSE
31 May 2016 Medical Device Safety Alert: Ethicon PHYSIOMESH Flexible Composite Mesh
31 May 2016 Medical Device Safety Alert: Roche Diagnostics Vancomycin
31 May 2016 Medical Device Safety Alert: Beckman Coulter AutoMate 2500 Family systems with Sorting-Drive software upgraded from version 4.1.2 to 4.2
30 May 2016 Medical Device Safety Alert: Edwards Lifesciences EV1000 Databox and Monitor
27 May 2016 Medical Device Safety Alert: Hummingbird Med Devices Inc ABG-HM-1 Hummi Micro-Draw Blood Transfer Device
26 May 2016 Medical Device Safety Alert: Draeger Disposable paediatric ventilation circuit for Oxylog Transport Ventilators
24 May 2016 Medical Device Safety Alert: Hospira Q core's Sapphire Infusion Pumps
24 May 2016 Medical Device Safety Alert: Roche Diagnostics ONLINE TDM Gentamicin assay with Preciset TDM I calibrator
20 May 2016 Medical Device Safety Alert: ConMed ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes
18 May 2016 Medical Device Safety Alert: Schiller FRED Easyport
18 May 2016 Medical Device Safety Alert: Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards
18 May 2016 Medical Device Safety Alert: Sterile Disposable Vaginal Speculums Manufactured by Taizhou Kangjian Medical Equipment Co., Ltd
16 May 2016 Medical Device Safety Alert: Medtronic Deep Brain Stimulation (DBS) system
13 May 2016 Medical Device Safety Alert: Biomérieux ARGENE reagents
11 May 2016 Medical Device Safety Alert: Intuitive Surgical da Vinci Xi 5 mm-8 mm Universal Seal and da Vinci Xi 12 mm & Stapler Universal Seal
10 May 2016 Medical Device Safety Alert: Volcano s5/s5i/CORE/CORE Mobile systems
10 May 2016 Medical Device Safety Alert: Cordis Precise Pro RX Nitinol Stent System (Carotid)
10 May 2016 Medical Device Safety Alert: Smiths Medical CADD Administration Sets with Flow Stop
09 May 2016 Medical Device Safety Alert: Beckman Coulter UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems
03 May 2016 Medical Device Safety Alert: Abbott ARCHITECT STAT High Sensitive Troponin-I Assay
29 Apr 2016 Medical Device Safety Alert: Medtronic RestoreSensor Implantable Neurostimulators
27 Apr 2016 Medical Device Safety Alert: Cook Medical Beacon Tip Catheters
26 Apr 2016 Medical Device Safety Alert: GCE Manual and Automatic Resuscitation System II
22 Apr 2016 Medical Device Safety Alert: Medtronic Bravo pH capsule delivery devices for Bravo pH Monitoring System
21 Apr 2016 Medical Device Safety Alert: Biosense Webster PENTARAY Catheters
18 Apr 2016 Medical Device Safety Alert: Roche Diagnostics cobas EGFR Mutation Test, v2 CE- IVD and cobas cfDNA Sample Preparation Kit
18 Apr 2016 Medical Device Safety Alert: Ethicon ENDOLOOP Product Code EH496
18 Apr 2016 Medical Device Safety Alert: Iris International IRISpec CA/CB/CC and IRISpec CA/CB
15 Apr 2016 Medical Device Safety Alert: Boston Scientific Lotus Valve Systems
08 Apr 2016 Medical Device Safety Alert: Elekta Leksell Gammaknife Perfexion and Icon
07 Apr 2016 Medical Device Safety Alert: Bard Hickman and Leonard Central Venous Catheter kits
06 Apr 2016 Medical Device Safety Alert: Jiangsu Rongye Technology AMED Mucus Trap 40cc
06 Apr 2016 Medical Device Safety Alert: Abbott ARCHITECT Estradiol Reagent
06 Apr 2016 Medical Device Safety Alert: SOMATOM Definition FORCE with VA50A, VA50A_SP2
05 Apr 2016 Medical Device Safety Alert: Stryker PneumoSure High Flow Insufflator
01 Apr 2016 Medical Device Safety Alert: Boston Scientific WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Devices with Delivery System
01 Apr 2016 Medical Device Safety Alert: Boston Scientific TLC Retractor Self-Retaining Retractor System
30 Mar 2016 Medical Device Safety Alert: Vascular Solutions Guardian II Hemostasis Valve
30 Mar 2016 Medical Device Safety Alert: Boston Scientific PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating
22 Mar 2016 Medical Device Safety Alert: Navilyst Medical Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) Valve Technology / Kits
22 Mar 2016 Medical Device Safety Alert: Powdered Medical Gloves
22 Mar 2016 Medical Device Safety Alert: Boston Scientific Ultraflex Tracheobronchial Covered Distal Release Stent System
22 Mar 2016 Medical Device Safety Alert: Medtronic Covidien Curity All Purpose Gauze Sponges, Curity X-Ray Detectable Laparotomy Sponges, Kerlix X-Ray Detectable Laparotomy Sponges, Vistec X-Ray Detectable Sponges
16 Mar 2016 Medical Device Safety Alert: Siemens Syngo X-Workplace with software version VD10E
11 Mar 2016 Medical Device Safety Alert: All ZeniPower Mercury-free Hearing Aid Batteries
09 Mar 2016 Medical Device Safety Alert: Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver
09 Mar 2016 Medical Device Safety Alert: Beckman Coulter DxH 500
07 Mar 2016 Medical Device Safety Alert: Maquet Cardiovascular Flow-i Anaesthesia System
03 Mar 2016 Medical Device Safety Alert: Ortho-Clinical Diagnostics Ortho BioVue Analyser
02 Mar 2016 Medical Device Safety Alert: Roche Diagnostics Estradiol II and Estradiol III
02 Mar 2016 Medical Device Safety Alert: Biosensors BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent Systems
01 Mar 2016 Medical Device Safety Alert: Storz Medical Modulith SLX-F2
26 Feb 2016 Medical Device Safety Alert: ARROW Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
18 Feb 2016 Medical Device Safety Alert: Bard Denali Inferior Vena Cava (IVC) Filter
18 Feb 2016 Medical Device Safety Alert: Ormco Corporation TF Adaptive Gutta Percha Point Size SM3-50pk
16 Feb 2016 Medical Device Safety Alert: Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect
15 Feb 2016 Medical Device Safety Alert: Bard TruGuide Disposable Coaxial Biopsy Needles
11 Feb 2016 Medical Device Safety Alert: Leonhard Lang Defibrillation electrodes
11 Feb 2016 Medical Device Safety Alert: PROTIME InRhythm System PT Test Cuvettes
05 Feb 2016 Medical Device Safety Alert: ACIST Medical Systems High Quality Sealing - Valve Introducer Catheter
04 Feb 2016 Medical Device Safety Alert: Abbott Vascular MitraClip Clip Delivery System
03 Feb 2016 Medical Device Safety Alert: Cook Medical Ultraxx Nephrostomy Balloon Set and Ascend AQ Ureteral Dilation Balloon Catheter Set
29 Jan 2016 Medical Device Safety Alert: Arkray Factory Inc SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip
29 Jan 2016 Medical Device Safety Alert: Sekisui Diagnostics Acetaminophen L3K Assay
26 Jan 2016 Medical Device Safety Alert: Iris International iChemVELOCITY Urine Chemistry Strips
25 Jan 2016 Medical Device Safety Alert: Thornhill Research Inc MOVES System and its Lithium Polymer Batteries
25 Jan 2016 Medical Device Safety Alert: Medtronic Puritan Bennett 980 Universal Ventilator System
14 Jan 2016 Recall of two batches of One Step HCG Pregnancy Test
14 Jan 2016 Medical Device Safety Alert: Baxter Healthcare Uromatic Tur Administration Set
13 Jan 2016 Medical Device Safety Alert: Terumo CVS CDI H/S Cuvettes
12 Jan 2016 Medical Device Safety Alert: CytoSorbents CytoSorb 300 mL Device
12 Jan 2016 Medical Device Safety Alert: Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature Monitor
04 Jan 2016 Boston Scientific Jagwire Straight and Angle Tip High Performance Guidewire
31 Dec 2015 Medical Device Safety Alert: Safety alert on Cardiac Science defibrillation electrodes (with photo)
30 Dec 2015 Medical Device Safety Alert: Cardiac Science Defibrillation Electrodes Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs
28 Dec 2015 Medical Device Safety Alert: Draeger Oxylog Transport Ventilators
17 Dec 2015 Medical Device Safety Alert: Arcadophta SARL Arcotane 5ml
15 Dec 2015 Medical Device Safety Alert: Medasil Airway (Guedel type)
07 Dec 2015 Medical Device Safety Alert: Abbott Vascular Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS Systems
07 Dec 2015 Medical Device Safety Alert: Beckman Coulter Unicel DxH Cellular Analysis Systems
01 Dec 2015 Medical Device Safety Alert: Brainlab Brain Metastases v1.0.0 and Adaptive Hybrid Surgery Analysis v1.0.0
30 Nov 2015 Medical Device Safety Alert: Beckman Coulter Access Ostase Calibrators and Access Ostase QC Kits
27 Nov 2015 Medical Device Safety Alert: IBA Dosimetry GmbH Electrical Lift Table
27 Nov 2015 Medical Device Safety Alert: bioMérieux Etest PIP/TAZO/CON‐4 PTC 256
26 Nov 2015 Medical Device Safety Alert: Kawasumi Laboratories Inc. Arterial Venous Fistula (AVF) sets for Haemodialysis - Safety AVF Needle fixed wing
26 Nov 2015 Medical Device Safety Alert: Boston Scientific IntellaTip MiFi XP Asymmetric (N4) Curve Temperature Ablation Catheters
25 Nov 2015 Medical Device Safety Alert: Infopia HemoCue HbA1c 501 Test Cartridges
25 Nov 2015 Medical Device Safety Alert: Intravascular Medical Devices
23 Nov 2015 Medical Device Safety Alert: Boston Scientific Chariot Guiding Sheath
20 Nov 2015 Medical Device Safety Alert: Philips Healthcare All Allura Xper, AlluraClarity, Allura CV, Allura Centron and UNIQ systems
16 Nov 2015 Medical Device Safety Alert: Custom Ultrasonics Automated Endoscope Reprocessors
12 Nov 2015 Medical Device Safety Alert: Depuy Synthes Attachment for Acetabular and Medullary Reaming
11 Nov 2015 Medical Device Safety Alert: Medtronic InSync III Cardiac Resynchronization Therapy Pacemakers
10 Nov 2015 Medical Device Safety Alert: NxStage System One S Cycler
05 Nov 2015 Medical Device Safety Alert: Baxter Healthcare Vented Paclitaxel Set
03 Nov 2015 Medical Device Safety Alert: Newdeal Sterile & Non-Sterile Individually Packaged BOLD 2.5 Compression Screw
03 Nov 2015 Medical Device Safety Alert: Baylis Medical ProTrack Microcatheter
30 Oct 2015 Medical Device Safety Alert: Quest Medical Myocardial Protection System Delivery Sets
30 Oct 2015 Medical Device Safety Alert: Rudolf Medical GmbH Continuous-Flow Outer Sheath for Resectoscope
28 Oct 2015 Medical Device Safety Alert: BioMerieux SLIDEX Strepto Plus
26 Oct 2015 Medical Device Safety Alert: Medtronic Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
23 Oct 2015 Medical Device Safety Alert: Orthotech VAIOS Total Shoulder Replacement System
22 Oct 2015 Medical Device Safety Alert: Thermo Fisher Scientific BRAHMS Neopterin EIA
22 Oct 2015 Medical Device Safety Alert: Brainlab iPlan RT Image / iPlan RT and BrainSCAN
20 Oct 2015 Medical Device Safety Alert: eVent Medical Inspiration LS, and i Series Ventilator Systems
16 Oct 2015 Medical Device Safety Alert: Boston Scientific RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation Device
16 Oct 2015 Medical Device Safety Alert: All heater-cooler devices provide heated and/or cooled water to oxygenator heat exchangers, cardioplegia heat exchangers and/or warming/cooling blankets
16 Oct 2015 Medical Device Safety Alert: Beckman Coulter Access CEA Reagent Kit for UniCel DxI Immunoassay Systems and Access 2 Immunoassay System
14 Oct 2015 Medical Device Safety Alert: Tornier MoPyC Radial Head Prosthesis Stem
13 Oct 2015 Medical Device Safety Alert: JenaValve prosthesis
07 Oct 2015 Medical Device Safety Alert: Ethicon HARMONIC ACE+ 7 Shears
07 Oct 2015 Medical Device Safety Alert: Varian ARIA for Radiation Oncology, ARIA Oncology Information System for Radiation Oncology
06 Oct 2015 Medical Device Safety Alert: Mercury Medical T-Piece Circuit
06 Oct 2015 Medical Device Safety Alert: Bioprosthetic Aortic Valves Reduced Leaflet Motion
06 Oct 2015 Medical Device Safety Alert: GI Dynamics EndoBarrier Gastrointestinal Liner System
02 Oct 2015 Medical Device Safety Alert: Prism Medical P300 and C300 Ceiling Hoist
02 Oct 2015 Medical Device Safety Alert: Siemens ADVIA Chemistry Systems Hemoglobin A1c_3 & A1c_3M Reagent kits
02 Oct 2015 Medical Device Safety Alert: Advanced Sterilization Products Sterrad NX Sterilizer
29 Sep 2015 Medical Device Safety Alert: Spacelabs Healthcare Arkon Anesthesia Delivery System
29 Sep 2015 Medical Device Safety Alert: Cranial Perforators with Automatic Clutch Mechanism
29 Sep 2015 Medical Device Safety Alert: Brainlab Patient Data Manager and Origin Data Management
29 Sep 2015 Medical Device Safety Alert: Beckman Coulter AU480 Chemistry Analyzer
25 Sep 2015 Medical Device Safety Alert: Silimed medical devices (all - including breast implants)
23 Sep 2015 Medical Device Safety Alert: Neoss Guide – Drill-Hubs I to V included in Neoss Guide Kit
23 Sep 2015 Medical Device Safety Alert: Biocompatibles UK TheraSphere Yttrium 90 Glass Microspheres
23 Sep 2015 Medical Device Safety Alert: Boston Scientific INLIVEN Cardiac Resynchronization Therapy Pacemakers
21 Sep 2015 Medical Device Safety Alert: SynCardia Systems Freedom Driver Systems used with the SynCardia temporary Total Artificial Heart (TAH-t)
18 Sep 2015 Medical Device Safety Alert: Flexible Bronchoscopes Reprocessing
17 Sep 2015 Medical Device Safety Alert: Boston Scientific EndoVive One Step Button, EndoVive Button Decompression Tube and EndoVive Low Profile Replacement Button
16 Sep 2015 Medical Device Safety Alert: Backup battery expiration for "Pocket" System Controller used with the HeartMate II Left Ventricular Assist System
16 Sep 2015 Medical Device Safety Alert: Baxter CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
16 Sep 2015 Medical Device Safety Alert: Depuy Synthes Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument
09 Sep 2015 Medical Device Safety Alert: Compounded or Repackaged Drugs Stored in Becton-Dickinson (BD) syringes (Updated)
08 Sep 2015 Medical Device Safety Alert: Beckman Coulter COULTER Ac•T Pak Reagent Kit, COULTER Ac•T Tainer Reagent Kit, COULTER Diff Ac•T Pak and COULTER Diff Ac•T Tainer
08 Sep 2015 Medical Device Safety Alert: IMPAC Medical Systems XiO Release 4.51 and higher
07 Sep 2015 Medical Device Safety Alert: Ethicon SEDASYS Computer-Assisted Personalized Sedation System
02 Sep 2015 Medical Device Safety Alert: Teleflex Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip and Flexislip Stylet, Sterile Pack
02 Sep 2015 Medical Device Safety Alert: Covidien Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes
01 Sep 2015 Medical Device Safety Alert: Terumo BCT Spectra Optia Apheresis Systems
01 Sep 2015 Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
31 Aug 2015 Medical Device Safety Alert: Draeger Infinity Acute Care System Evita Infinity V500
28 Aug 2015 Medical Device Safety Alert: WATCHMAN Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Access System
28 Aug 2015 Medical Device Safety Alert: CareFusion Alaris Medley Large Volume Pump Frame Membrane
25 Aug 2015 Medical Device Safety Alert: CareFusion Alaris System Syringe Module
24 Aug 2015 Medical Device Safety Alert: Freestyle Optium Neo Blood Glucose and Ketone Monitoring System
21 Aug 2015 Medical Device Safety Alert: Philips Healthcare Brilliance 64 and Ingenuity CT Scanners
21 Aug 2015 Medical Device Safety Alert: Becton-Dickinson (BD) 3 millilitre (ml) and 5 ml syringes
19 Aug 2015 Medical Device Safety Alert: Advanced Sterilization Products CIDEX OPA Solution
13 Aug 2015 Medical Device Safety Alert: Brainlab ExacTrac v. 6.0.x Patient Positioning System
11 Aug 2015 Medical Device Safety Alert: Boston Scientific AngioJet Ultra Catheters
07 Aug 2015 Medical Device Safety Alert: Medtronic Elongated One-Piece Arterial Arterial Cannula
07 Aug 2015 Medical Device Safety Alert: Synthes GmbH Hexagonal Socket, Ø 4.0mm/11.0mm
06 Aug 2015 Medical Device Safety Alert: Implantable Left Ventricular Assist Devices
04 Aug 2015 Medical Device Safety Alert: Nipro Europe NV SUREFLUX 25UX LC GA
04 Aug 2015 Medical Device Safety Alert: Advanced Sterilization Products CIDEX Activated Glutaraldehyde Solution
24 Jul 2015 Medical Device Safety Alert: Breas Vivo 50 Home Care Ventilator
23 Jul 2015 Medical Device Safety Alert: DiaMed Lyra MP Reader II
23 Jul 2015 Medical Device Safety Alert: Covidien Puritan Bennett 980 series Universal ventilator system
16 Jul 2015 Medical Device Safety Alert: Medtronic EnVeo R Loading System
16 Jul 2015 Medical Device Safety Alert: Ossur Female Adapters on Prosthetic Feet
14 Jul 2015 Medical Device Safety Alert: SentreHEART Lariat Suture Delivery Device
06 Jul 2015 Medical Device Safety Alert: Philips Medical Systems HeartStart XL+ Defibrillator/Monitor
03 Jul 2015 Medical Device Safety Alert: Biosense Webster nMARQ Circular Irrigated Catheter
02 Jul 2015 Medical Device Safety Alert: Boston Scientific Extractor Pro RX 12-15mm Above Retrieval Balloon Catheter
24 Jun 2015 Medical Device Safety Alert: SENSE Body Coil 1.5T used with ACS NT, Intera 1.5T and Achieva 1.5T MR System
23 Jun 2015 Medical Device Safety Alert: Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks
22 Jun 2015 Medical Device Safety Alert: Orsiro Sirolimus Eluting Coronary Stent System
22 Jun 2015 Medical Device Safety Alert: Abutment Retrieval Instrument and Kit
19 Jun 2015 Medical Device Safety Alert: Fabius MRI anesthesia system
19 Jun 2015 Medical Device Safety Alert: DePuy Synthes ATTUNE INTUITION Tibial Articulation Surface Instruments
19 Jun 2015 Medical Device Safety Alert: Synthes GmbH TFNA Helical-Blade Impactor
17 Jun 2015 Medical Device Safety Alert: HeartWare Ventricular Assist System
11 Jun 2015 Medical Device Safety Alert: Medtronic MiniMed Sure-T infusion sets
10 Jun 2015 Medical Device Safety Alert: Bedfont Scientific NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device
08 Jun 2015 Medical Device Safety Alert: Boston Scientific CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recoding System
04 Jun 2015 Medical Device Safety Alert: Alcon Accurus Standalone Vitreous Probe Paks
04 Jun 2015 Medical Device Safety Alert: Baxter Vascu-Guard Peripheral Vascular Patch
03 Jun 2015 Medical Device Safety Alert: Boston Scientific Autogen and Dynagen
28 May 2015 Medical Device Safety Alert: Smiths Medical CADD-Solis Ambulatory Infusion Pumps
28 May 2015 Medical Device Safety Alert: Unomedical SURE-T, SURE-T Paradigm, contact detach, contact, Sub Q, neria, neria detach, neria multi, thalaset
22 May 2015 Medical Device Safety Alert: Zimmer Tibial Alignment Guide – iAssist Knee System
21 May 2015 Medical Device Safety Alert: HeartWare Ventricular Assist System Pump Driveline Splice Kit
19 May 2015 Medical Device Safety Alert: Stryker Navigation System II-Cart and Articulated Arm Camera
18 May 2015 Medical Device Safety Alert: Abbott Laboratories Alkaline Wash
15 May 2015 Medical Device Safety Alert: Covidien Shiley Neonatal, Paediatric and Long Paediatric Tracheostomy Tube, Cuffless and with TaperGuard Cuff
14 May 2015 Medical Device Safety Alert: Boston Scientific Repliform Tissue Regeneration Matrix
14 May 2015 Medical Device Safety Alert: ResMed Adaptive-Servo-Ventilation Therapy
12 May 2015 Medical Device Safety Alert: Baxter Healthcare CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
11 May 2015 Medical Device Safety Alert: Leonhard Lang Corpatch Easy Pediatric
11 May 2015 Medical Device Safety Alert: Invacare Platinum Oxygen Concentrator
08 May 2015 Medical Device Safety Alert: Baxter Healthcare COLLEAGUE SINGLE CHANNEL CXE PUMP, V1 .7
05 May 2015 Medical Device Safety Alert: Smith & Nephew ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
05 May 2015 Medical Device Safety Alert: Roche CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL/TG, TRIGGB, TRIG/GB, CHOL/CHOL2, HDL-C plus 3rd generation/HDLC3, LDL_C plus 2nd generation/LDL_C, UA2/UA plus
04 May 2015 Medical Device Safety Alert: Boston Scientific Extractor Pro RX 9-12mm Above Retrieval Balloon Catheter
04 May 2015 Medical Device Safety Alert: Medtronic VenaSeal Closure System Model SP-101
30 Apr 2015 Medical Device Safety Alert: GE Healthcare D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors
27 Apr 2015 Medical Device Safety Alert: Synthes GmbH TFN-ADVANCED Proximal Femoral Nailing System
27 Apr 2015 Medical Device Safety Alert: Laerdal Compact Suction Unit
23 Apr 2015 Medical Device Safety Alert: Brainlab ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software
22 Apr 2015 Medical Device Safety Alert: All posture or safety belts fitted to supportive seating, wheelchairs, hoists and bathroom equipment
20 Apr 2015 Medical Device Safety Alert: Smiths Medical Portex Bivona Inner Cannula for Bivona Adult Tracheostomy Tubes
17 Apr 2015 Medical Device Safety Alert: LuSys Laboratories Ebola Virus One Step Test Kits
17 Apr 2015 Medical Device Safety Alert: OriGen Biomedical VV13F Reinforced Dual Lumen ECMO Catheters
16 Apr 2015 Medical Device Safety Alert: Medtronic Neuromodulation Deep Brain Stimulation system extensions
15 Apr 2015 Recall of syringe slip tip (with photo)
15 Apr 2015 Medical Device Safety Alert: Boston Scientific Lotus Valve System
15 Apr 2015 Medical Device Safety Alert: DePuy Synthes Oscillating Saw Attachment for Colibri / Colibri II / Small Electric Drive
15 Apr 2015 Medical Device Safety Alert: Fresenius Medical Care Haemodialysis bloodline for 4008 dialysis machine
14 Apr 2015 Medical Device Safety Alert: Ortho-clinical VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below
09 Apr 2015 Medical Device Safety Alert: Roche UREA/BUN for Modular system
31 Mar 2015 Medical Device Safety Alert: Elekta Digital Linear Accelerator
25 Mar 2015 Medical Device Safety Alert: CooperSurgical Wallach LL100 Cryosurgical System
24 Mar 2015 Medical Device Safety Alert: Uninterruptable Power Supply (UPS) Batteries used with Philips CT and Molecular Imaging Systems
19 Mar 2015 Medical Device Safety Alert: DePuy Synthes Cross-Link Clamp for Rods Ø 6.0 mm, preassembled, Titanium Alloy (TAN), dark blue
16 Mar 2015 Medical Device Safety Alert: Abbott Medical Optics Catalys Precision Laser System
16 Mar 2015 Medical Device Safety Alert: Medtronic Model 5392 Dual-Chamber External Pulse Generator
12 Mar 2015 Medical Device Safety Alert: SONY LMD-1951MD Monitors used with SpyGlass
12 Mar 2015 Medical Device Safety Alert: Ethicon Endo-Surgery ENDOPATH ECHELON Vascular White Reload for Advanced Placement Tip (35mm, 4 row)
11 Mar 2015 Medical Device Safety Alert: Brainlab ExacTrac v. 6.x – Cone Beam Computed Tomography (CBCT) Import & Alignment Software
11 Mar 2015 Medical Device Safety Alert: Synthes GmbH Aiming Arm 125° and Aiming Arm 130° for TFN-ADVANCED (TFNA) System
09 Mar 2015 Medical Device Safety Alert: Fresenius Medical Care FX CorDiax Haemodiafilters and FX CorDiax High Flux dialysers
06 Mar 2015 Medical Device Safety Alert: Hospira Plum A+ infusion pumps and Plum A+3 infusion pumps
06 Mar 2015 Medical Device Safety Alert: Synthes GmbH Inserter for Titanium Elastic Nails
04 Mar 2015 Medical Device Safety Alert: Boston Scientific Expel Drainage Catheter with Twist-Loc Hub and Biliary Drainage Catheter Kit
03 Mar 2015 Medical Device Safety Alert: Accu-Chek Insight insulin pump cartridge (self-filled)
02 Mar 2015 Medical Device Safety Alert: Abbott Laboratories ARCHITECT Anti- HBc II Reagent
02 Mar 2015 Medical Device Safety Alert: PerkinElmer NeoBase Non-Derivatized Assay Solutions
27 Feb 2015 Medical Device Safety Alert: Alltech Medical Systems America Echostar Spica 1.5T MRI system
23 Feb 2015 Medical Device Safety Alert: MAQUET Servo Humidifier 163
23 Feb 2015 Medical Device Safety Alert: MAQUET Servo Humidifier 163
23 Feb 2015 Medical Device Safety Alert: Endoscopic Retrograde Cholangiopancreatography (ERCP) endoscopes
23 Feb 2015 Medical Device Safety Alert: Biosensors International BioPath 035
17 Feb 2015 Medical Device Safety Alert: Caesarea Medical Electronics BodyGuard 323 Infusion Pump
16 Feb 2015 Medical Device Safety Alert: IBA Dosimetry COMPASS 3.1 / 3.1a
13 Feb 2015 Medical Device Safety Alert: Gyrus Medical PlasmaSORD
09 Feb 2015 Medical Device Safety Alert: Datex-Ohmeda Engstrom Carestation
06 Feb 2015 Medical Device Safety Alert: Gambro AK 200 S and AK 200 ULTRA S Nocturnal Home Hemodialysis Machines
06 Feb 2015 Medical Device Safety Alert: William Cook Europe Zenith Alpha Thoracic Endovascular Graft
05 Feb 2015 Medical Device Safety Alert: BD MAX System Software Version 4.44A
02 Feb 2015 Medical Device Safety Alert: Western / Scott Fetzer Co. OxyTOTE Valve Integrated Pressure Regulators
23 Jan 2015 Medical Device Safety Alert: Terumo CVS Titan Stabilizers and Titan 360 Stabilizers
21 Jan 2015 Medical Device Safety Alert: Philips Healthcare MultiDiagnost Eleva FD
20 Jan 2015 Safety alert on component of peritoneal dialysis system (with photos)
16 Jan 2015 Medical Device Safety Alert: Brainlab Offset Cup Impactor Universal
15 Jan 2015 Medical Device Safety Alert: Clinical Innovations ebb Complete Tamponade System
14 Jan 2015 Medical Device Safety Alert: Gambro Artis/Evosys Dialysis System equipped with SW 8.15.06 and 8.33.02
13 Jan 2015 Medical Device Safety Alert: Medtronic Neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation
08 Jan 2015 Medical Device Safety Alert: GE Medical Systems Magnetic Resonance Imaging Systems
07 Jan 2015 Medical Device Safety Alert: Navilyst Medical Xcela Peripherally Inserted Central Catheter (PICC) with Pressure-Activated Safety Valve (PASV) Valve Technology / Kits and BioFlo PICC with Endexo and PASV Valve Technology / Kits
31 Dec 2014 Medical Device Safety Alert: Philips Heartstart MRx Defibrillator/Monitor
28 Dec 2014 Medical Device Safety Alert: HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery
23 Dec 2014 Medical Device Safety Alert: Baxter Healthcare Colleague P1.7 CXE Single Channel Pump and Colleague P1.7 CXE Triple Channel Pump
23 Dec 2014 Medical Device Safety Alert: Synthes GmbH Cheek Retractor, f/MatrixMANDIBLE U-shaped, Flexible
19 Dec 2014 Medical Device Safety Alert: Synthes GmbH Bending/Cutting Pliers with Nose for LOCK Plates 2.0
17 Dec 2014 Medical Device Safety Alert: OneTouch Ultra 1x50 Glucose Test Strips
16 Dec 2014 Medical Device Safety Alert: Owen Mumford Autopen, Autopen 24, Densupen and Autopen 3ml for Teriparatide
12 Dec 2014 Medical Device Safety Alert: Philips Medical Systems M1783A and M5526A 12 pin Sync Cables
09 Dec 2014 Medical Device Safety Alert: Philips Medical Systems HeartStart MRx Monitor/Defibrillator
08 Dec 2014 Medical Device Safety Alert: GE Healthcare Defibrillation Electrode for Children (Leonhard Lang) used with GE defibrillators
08 Dec 2014 Medical Device Safety Alert: Synthes GmbH Small Electric Drive
05 Dec 2014 Medical Device Safety Alert: Philips Medical Systems Heartstart MRx Defibrillator/Monitor
04 Dec 2014 Medical Device Safety Alert: Heart Sync Inc. Multi-function Defibrillation Electrodes
02 Dec 2014 Medical Device Safety Alert: Leonhard Lang Skintact DF32L and DF31L Defibrillation Electrodes for Children
02 Dec 2014 Medical Device Safety Alert: Instrumentation Laboratory HemosIL PT-Fibrinogen HS PLUS
28 Nov 2014 Medical Device Safety Alert: Philips Healthcare IntelliSpace Critical Care & Anesthesia Clinical Information System
27 Nov 2014 Medical Device Safety Alert: CONMED PadPro and R2 Multi-function Defibrillation Electrodes
27 Nov 2014 Medical Device Safety Alert: Advanced Sterilization Products STERRAD Systems
25 Nov 2014 Medical Device Safety Alert: Codan Argus Syringe Pump Green Stream SY-P ARGUS 600 and Argus 600
21 Nov 2014 Medical Device Safety Alert: Halyard Health (Kimberly-Clark) Kimvent* Subglottic Suctioning Endotracheal Tubes
21 Nov 2014 Medical Device Safety Alert: Respironics Esprit V1000 and Esprit/V200 Conversion Ventilators
19 Nov 2014 Medical Device Safety Alert: Abbott Medical Optics Healon EndoCoat Ophthalmic Viscosurgical Device
18 Nov 2014 Medical Device Safety Alert: BeneHeart D1 Defibrillator/ Monitor
18 Nov 2014 Medical Device Safety Alert: Boston Scientific AUTOGEN DR ICDs and CRT-Ds
18 Nov 2014 Medical Device Safety Alert: Synthes Drill Bit 2.0mm drilling depth 14mm, 3-flute, for Quick Coupling
17 Nov 2014 Medical Device Safety Alert: Baxter Healthcare INTRA VIA Container with PVC Ports
14 Nov 2014 Medical Device Safety Alert: BD ProbeTec Chlamydia trachomatis (CT) Qx Assay and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay
13 Nov 2014 Medical Device Safety Alert: Bausch & Lomb Stellaris PC Vision Enhancement System with Integrated Laser
12 Nov 2014 Medical Device Safety Alert: HemoCue Glucose 201 Microcuvettes single packed
11 Nov 2014 Medical Device Safety Alert: Medtronic MiniMed Silhouette and MiniMed Sure-T infusion sets
11 Nov 2014 Medical Device Safety Alert: Renishaw neuro / inspire - surgical planning software
06 Nov 2014 Medical Device Safety Alert: Fisher & Paykel Healthcare IW900-series Infant Warmers
06 Nov 2014 Medical Device Safety Alert: Hospira GemStar Power Supply 3VDC
04 Nov 2014 Medical Device Safety Alert: Medtronic Styker's Berchtold F-generation LED lights
31 Oct 2014 Medical Device Safety Alert: CooperSurgical Radius Loop Electrode Box of 5
28 Oct 2014 Medical Device Safety Alert: Invitech Pregnancy Test Cassettes and Dipsticks
28 Oct 2014 Medical Device Safety Alert: BioMérieux VIDAS Cortisol S
28 Oct 2014 Medical Device Safety Alert: KOR Innovations Euro Lift 2005 ND
24 Oct 2014 Medical Device Safety Alert: BioMérieux VIDAS 3 System
24 Oct 2014 Medical Device Safety Alert: Kimal KFlow Epic Catheter Range
23 Oct 2014 Medical Device Safety Alert: Biosense Webster THERMOCOOL SMARTTOUCH Catheter
23 Oct 2014 Medical Device Safety Alert: IBA Dosimetry GmbH COMPASS Software version 3.1
17 Oct 2014 Medical Device Safety Alert: Thermo Scientific Richard-Allan Scientific 10% Neutral Buffered Formalin
15 Oct 2014 Medical Device Safety Alert: Philips IntelliVue Patient Monitors and Avalon Fetal Monitors
14 Oct 2014 Medical Device Safety Alert: Intersurgical nFlow Infant Nasal CPAP Breathing System
14 Oct 2014 Medical Device Safety Alert: Abbott Diabetes Care FreeStyle Libre Flash Glucose Monitoring System
10 Oct 2014 Medical Device Safety Alert: GE Millenium VG Variable Geometry Dual Detector Camera-Hawkeye, Hawkeye 4, Infinia Dual Detector Gamma Camera, Discovery NM/CT 670 and NM 630 System
09 Oct 2014 Medical Device Safety Alert: SAM Medical Products Junctional Tourniquet
08 Oct 2014 Medical Device Safety Alert: Teleflex Medical Hudson RCI Pediatric Anaesthesia Breathing Circuits
06 Oct 2014 Medical Device Safety Alert: Biomerieux API LISTERIA 10STRIPS+10MEDIA
03 Oct 2014 Medical Device Safety Alert: ConMed Stat 2 flow controller
03 Oct 2014 Medical Device Safety Alert: CareFusion EnVe and ReVel Ventilators
03 Oct 2014 Medical Device Safety Alert: Roche Diagnostics Accu-Chek Spirit Combo Insulin Pumps
03 Oct 2014 Medical Device Safety Alert: Coopervision Proclear Toric Soft Hydrophilic Contact Lenses
02 Oct 2014 Medical Device Safety Alert: Biosense Webster CARTOSOUND Module of the CARTO 3 EP Navigation System
30 Sep 2014 Medical Device Safety Alert: Hangzhou Clongene Biotech CLUNGENE hCG Pregnancy Test
30 Sep 2014 Medical Device Safety Alert: CODAN ARGUS Infusion pump CODAN ARGUS 71XV and Syringe pump CODAN ARGUS 606S
30 Sep 2014 Medical Device Safety Alert: Siemens CLINITEK Status, CLINITEK Status+, and CLINITEK Status Connect Systems
29 Sep 2014 Medical Device Safety Alert: Siemens Stereo Biopsy Device used with Mammomat Inspiration Mammography System
29 Sep 2014 Medical Device Safety Alert: Covidien Ltd Aeroneb Pro and Solo Nebuliser Systems - FRIWO power adapter
29 Sep 2014 Medical Device Safety Alert: Covidien LLC Kendall 1010P Multi-Function Defibrillation Electrodes & Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes
25 Sep 2014 Medical Device Safety Alert: Alcon AcrySof CACHET PHAKIC Lens
23 Sep 2014 Medical Device Safety Alert: Bedfont Scientific NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device
17 Sep 2014 Medical Device Safety Alert: Device Technologies Defibrillator/pacer SLIM corpuls3
16 Sep 2014 Medical Device Safety Alert: Terumo CVS Hercules 360 Universal Stabilizing Arm
16 Sep 2014 Medical Device Safety Alert: Ethicon ECHELON ENDOPATH Endoscopic Linear Cutter Reloads in Sleeve Gastrectomy Procedures
12 Sep 2014 Medical Device Safety Alert: Kerr Premise Universal Restorative Body Syringe and Unidose, Shade A2
11 Sep 2014 Medical Device Safety Alert: Boston Scientific OffRoad Re-Entry Catheter System
11 Sep 2014 Medical Device Safety Alert: Update on risk of uterine perforation with intrauterine devices
10 Sep 2014 Medical Device Safety Alert: The mains power adapters used in the Aeroneb Solo, Pro, USB and NIVO Nebuliser systems
03 Sep 2014 Medical Device Safety Alert: Siemens V5Ms transesophageal transducer
02 Sep 2014 Medical Device Safety Alert: Dräger Babytherm Infant Warmers
02 Sep 2014 Medical Device Safety Alert: Volcano Corporation Trak Back Pullback Device
26 Aug 2014 Medical Device Safety Alert: Customed Sterile Convenience Surgical Packs
22 Aug 2014 Medical Device Safety Alert: Siemens ADVIA Chemistry Systems A1c_3 calibrator
20 Aug 2014 Medical Device Safety Alert: Cardiovascular Systems, Inc. Diamondback 360 Peripheral Orbital Atherectomy System
20 Aug 2014 Medical Device Safety Alert: St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators
19 Aug 2014 Medical Device Safety Alert: Sorin Heart Valves
19 Aug 2014 Medical Device Safety Alert: Maquet Venous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160
12 Aug 2014 Medical Device Safety Alert: Bolton Medical Relay and Relay NBS Thoracic Stent-Graft Systems
12 Aug 2014 Medical Device Safety Alert: Philips Healthcare Ingenia, Intera, Achieva and Achieva dStream MR systems
12 Aug 2014 Medical Device Safety Alert: Siemens Symbia T Series and Symbia Intevo Camera System
08 Aug 2014 Medical Device Safety Alert: Philips Healthcare Pinnacle3 Radiation Treatment Planning System
07 Aug 2014 Medical Device Safety Alert: Wellspring Pharmaceutical Corporation IPM Wound Gel Rx Wound Dressing
07 Aug 2014 Medical Device Safety Alert: Sorin Heater Cooler Device
07 Aug 2014 Medical Device Safety Alert: Philips Healthcare IntelliSpace Portal DX/HX/EX, IntelliSpace Portal IX, and IntelliSpace Portal LX SPECT
05 Aug 2014 Medical Device Safety Alert: Gambro Ultrafilter U9000
01 Aug 2014 Medical Device Safety Alert: BD MAX MRSA Assay
01 Aug 2014 Medical Device Safety Alert: Synthes T-PAL, Technique Guide
31 Jul 2014 Medical Device Safety Alert: Baxter Dura-Guard and Peri-Guard
28 Jul 2014 Medical Device Safety Alert: Ortho Clinical Diagnostics Blood Grouping Reagent MTS A/B/D Monoclonal and Reverse Grouping Card
25 Jul 2014 Medical Device Safety Alert: Baxter BURETROL Solution Set with 150ml INTERLINK Burette
23 Jul 2014 Medical Device Safety Alert: Baxter Coseal Surgical Sealant 2ml and 4 ml sizes
22 Jul 2014 Medical Device Safety Alert: Mitsubishi VERO /MHI-TM2000 linear accelerator system with software version 3.0.0 and after
22 Jul 2014 Medical Device Safety Alert: Elekta XVI R4.0 to R4.2.1, R4.5.0, R4.5.1 and R5.0.0 to R5.0.1
21 Jul 2014 Medical Device Safety Alert: GE Healthcare OEC 9900 systems
21 Jul 2014 Medical Device Safety Alert: Terumo BCT Spectra Optia Apheresis System
17 Jul 2014 Medical Device Safety Alert: Systagenix Wound Management Ltd. TOPPER Xtra Absorbent Dressing Pads
17 Jul 2014 Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Immunodiagnostic Products TSH Calibrators; VITROS Immunodiagnostic Products TSH Reagent Packs
17 Jul 2014 Medical Device Safety Alert: Baxter EXACTAMIX Compounders
15 Jul 2014 Safety alert on Cellnovo insulin infusion set
11 Jul 2014 Medical Device Safety Alert: Pedal of footswitch for Philips MultiDiagnost Eleva FD Systems and Allura Xper Systems
09 Jul 2014 Medical Device Safety Alert: Philips Healthcare Allura Xper Radiographic Systems
08 Jul 2014 Medical Device Safety Alert: International Technidyne ITC Hemochron JR APTT Test Cuvette
25 Jun 2014 Medical Device Safety Alert: Creganna-Tactx / Cordis EMPIRA NC RX PTCA Dilatation Catheter and EMPIRA RX PTCA Dilatation Catheter
24 Jun 2014 Medical Device Safety Alert: Ortho-Clinical Diagnostics ORTHO BLISS
24 Jun 2014 Medical Device Safety Alert: Varian Medical Systems C-Series High Energy Linear Accelerator
23 Jun 2014 Medical Device Safety Alert: ConvaTec Flexi-Seal CONTROL Fecal Management System Kit
20 Jun 2014 Medical Device Safety Alert: Bio-Rad Biotestcell I8, Biotestcell I11 and Biotestcell I11E
20 Jun 2014 Medical Device Safety Alert: Terumo Advanced Perfusion System 1
19 Jun 2014 Medical Device Safety Alert: Nitinol Devices & Components Hydrofinity Hydrophilic Guidewire
19 Jun 2014 Medical Device Safety Alert: Teoxane Teosyal products
13 Jun 2014 Medical Device Safety Alert: CryoLife BioGlue Surgical Adhesive 5mL
13 Jun 2014 Medical Device Safety Alert: Smiths Medical Portex Low Dead Space Connector with Sideport
12 Jun 2014 Safety alert over Advocate Redi-Code+ blood glucose test strip
09 Jun 2014 Medical Device Safety Alert: Covidien Puritan Bennett 840 Ventilator
06 Jun 2014 Medical Device Safety Alert: Physio-Control LIFEPAK 1000 Defibrillator
26 May 2014 Medical Device Safety Alert: Roche Loose ProCell / CleanCell Aspiration Tube Filter on MODULAR ANALYTICS , cobas e601 and cobas e602
23 May 2014 Medical Device Safety Alert: Baxter ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0
23 May 2014 Medical Device Safety Alert: Roche Accu-Chek Mobile System
21 May 2014 Medical Device Safety Alert: CareFusion Alaris Pump Module
21 May 2014 Medical Device Safety Alert: Boston Scientific IntellaTip Mifi XP Temperature Ablation Catheter
19 May 2014 Medical Device Safety Alert: Ventlab Resuscitator Bags
15 May 2014 Medical Device Safety Alert: Baxter MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp
08 May 2014 Medical Device Safety Alert: Philips Healthcare Ingenia, Intera, Achieva and Multiva MR systems using R5.1.1 and R5.1.2 version of software
08 May 2014 Medical Device Safety Alert: HeartWare Ventricular Assist System Batteries
07 May 2014 Medical Device Safety Alert: Bedfont Scientific NOxBOXi inhaled Nitric Oxide Delivery and Monitoring Device
07 May 2014 Medical Device Safety Alert: Alere INRatio2 PT/INR Professional Test Strips
05 May 2014 Medical Device Safety Alert: Medtronic Model 5348 Single-Chamber External Pulse Generator
05 May 2014 Medical Device Safety Alert: Abbott Acclaim Infusion Pumps and Hospira Acclaim Encore Infusion Pumps
02 May 2014 Medical Device Safety Alert: Roche Calcium Gen.2 (CA2)
30 Apr 2014 Safety alert over GenStrip Blood Glucose Test Strips
29 Apr 2014 Medical Device Safety Alert: Cardiocom Commander FLEX UK power supply
25 Apr 2014 Medical Device Safety Alert: Terumo CVS Sarns Disposable Centrifugal Pump
23 Apr 2014 Medical Device Safety Alert: Baxter Peritoneal Dialysis Transfer Sets, Titanium Adapters, Disconnect Caps and Clamshells
22 Apr 2014 Medical Device Safety Alert: GE Healthcare Panda iRes Warmers integrated with Nellcor SpO2
17 Apr 2014 Medical Device Safety Alert: Spacelabs ARKON Anesthesia Delivery System with Version 2.0 Software
17 Apr 2014 Medical Device Safety Alert: Hospira Nonvented Y-Set
16 Apr 2014 Medical Device Safety Alert: Fisher & Paykel Infant Nasal Continuous Positive Airway Pressure (CPAP) Prongs and Bubble CPAP Starter Kits
15 Apr 2014 Medical Device Safety Alert: Biosense Webstar THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip Catheter
15 Apr 2014 Medical Device Safety Alert: Philips Brilliance CT series (6, 10, 16, 16 Power, 40, 64, Big Bore, iCT, iCT SP), Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and MX8000 Dual v. EXP
14 Apr 2014 Medical Device Safety Alert: Varian C-Series Clinac, version 2.x through 6.x
11 Apr 2014 Medical Device Safety Alert: Biomerieux Mueller Hinton 2 Agar
10 Apr 2014 Safety alert over certain brands of Roche Diabetes Care blood glucose test strips and blood glucose monitoring systems
09 Apr 2014 Medical Device Safety Alert: Philips HeartStart XL+ Defibrillator/Monitor
08 Apr 2014 Medical Device Safety Alert: Advanced Sterilization Products CIDEX OPA Solution Test Strips
07 Apr 2014 Medical Device Safety Alert: Boston Scientific NovaGold Guidewire
04 Apr 2014 Medical Device Safety Alert: Philips DigitalDiagnost Patient support for stitching
01 Apr 2014 Medical Device Safety Alert: Draeger Ondal AC2000 Spring-Loaded Arm
28 Mar 2014 Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Products FS Diluent Pack 3
28 Mar 2014 Medical Device Safety Alert: Life Partners Easy Life Balloon
26 Mar 2014 Medical Device Safety Alert: Megadyne Hand Control 12FR Suction Coagulator with 10 foot Cord and Holster, Sterile, Disposable
26 Mar 2014 Medical Device Safety Alert: Medrad Continuum MR Infusion System - Pump
26 Mar 2014 Medical Device Safety Alert: Varian Medical Systems On-Board Imager
22 Mar 2014 Medical Device Safety Alert: CooperVision Biomedics 1 day (55%) toric contact lenses
21 Mar 2014 Medical Device Safety Alert: Abbott I-stat 1 Analyzer system - G3+ Cartridge
20 Mar 2014 Medical Device Safety Alert: Roche cobas c pack CARB3
19 Mar 2014 Medical Device Safety Alert: Medtronic insulin pumps
19 Mar 2014 Medical Device Safety Alert: Boston Scientific Teleflex Medical CAPIO Sutures
19 Mar 2014 Medical Device Safety Alert: Baxter HomeChoice PRO Automated Peritoneal Dialysis (PD) System
18 Mar 2014 Medical Device Safety Alert: Medtronic SynchroMed II Implantable Drug Infusion Pump
18 Mar 2014 Medical Device Safety Alert: Gambro Single Needle Bloodlines for AK Machines
14 Mar 2014 Medical Device Safety Alert: Plum A+ Infusion Volumetric Infusion Pump
13 Mar 2014 Medical Device Safety Alert: McKesson Anesthesia Care System
13 Mar 2014 Medical Device Safety Alert: Greatbatch Medical Standard Offset Cup Impactor
13 Mar 2014 Medical Device Safety Alert: Medtronic Endo-Scrub 2 Sheaths & Tubing Set
12 Mar 2014 Medical Device Safety Alert: Roche Diagnostics Accu-Chek Spirit Combo insulin pump
11 Mar 2014 Medical Device Safety Alert: Draeger Reusable latex breathing bags
11 Mar 2014 Medical Device Safety Alert: Biomerieux FB (Fast blue BB), ZYM B reagent, API Listeria, and API NH
07 Mar 2014 Medical Device Safety Alert: Terumo Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae
07 Mar 2014 Medical Device Safety Alert: Boston Scientific RunWay Guide Catheter
07 Mar 2014 Medical Device Safety Alert: Philips Healthcare Automated External Defibrillator HeartStart FR3
07 Mar 2014 Medical Device Safety Alert: Philips Healthcare Automated External Defibrillator HeartStart Home and Onsite (HS1)
05 Mar 2014 Medical Device Safety Alert: Roche MagNA Pure 96 Instrument
05 Mar 2014 Medical Device Safety Alert: Baxter INFUSOR Portable Elastomeric Infusion System
04 Mar 2014 Medical Device Safety Alert: HeartSine Samaritan PAD 500P Automated External Defibrillators
04 Mar 2014 Medical Device Safety Alert: Accumetrics VerifyNow IIb/IIIa 25-Test and 10-Test Kits
03 Mar 2014 Recall of certain brands of Abbott Diabetes Care blood glucose monitoring systems
27 Feb 2014 Medical Device Safety Alert: Merit Medical Systems custom procedural trays or kits containing 1% Lidocaine HCl Injection
26 Feb 2014 Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
26 Feb 2014 Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
26 Feb 2014 Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillator
24 Feb 2014 Medical Device Safety Alert: Cereplas Cereform silicone gel-filled breast implants
20 Feb 2014 Medical Device Safety Alert: Draeger V Series Ventilators
20 Feb 2014 Medical Device Safety Alert: Draeger Oxylog Transport Ventilators
20 Feb 2014 Medical Device Safety Alert: Alere Triage Cardio 3
20 Feb 2014 Medical Device Safety Alert: Philips HeartStart MRx Lithium Ion batteries
19 Feb 2014 Medical Device Safety Alert: Philips Trilogy Ventilators
18 Feb 2014 Medical Device Safety Alert: Medica HDF On-line
14 Feb 2014 Medical Device Safety Alert: Abbott Laboratories ARCHITECT Intact PTH Assay
13 Feb 2014 Medical Device Safety Alert: Medtronic spinal cord stimulation neurostimulators, spinal cord stimulation leads, kits and patient programmers
12 Feb 2014 Medical Device Safety Alert: Biomerieux Etest Ertapenem
11 Feb 2014 Medical Device Safety Alert: Arrow International Arrow Edge Hemodialysis Catherization Set Long-Term Access, Arrow NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access
11 Feb 2014 Medical Device Safety Alert: Medtronic Select 3D and Select CAP Arterial Cannula
07 Feb 2014 Medical Device Safety Alert: GE Healthcare Precision 500D and Proteus XR/a with Wireless Digital Radiography Option (Fluoroscopic X-Ray System)
07 Feb 2014 Medical Device Safety Alert: Ortho Clinical Diagnostics Calibration Data Module
06 Feb 2014 Medical Device Safety Alert: Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilatation Catheter and MONORAIL PTA Balloon Dilatation Catheter
05 Feb 2014 MHRA Field Safety Notice: Cardiac Science Powerheart G5 Automated External Defibrillator (AED) Electrode Connector
30 Jan 2014 Medical Device Safety Alert: Philips Ingenia 1.5T and Ingenia 3.0T Magnetic Resonance systems
29 Jan 2014 Medical Device Safety Alert: Ortho Clinical Diagnostics VITROS 25-OH Vitamin D Total Calibrators
28 Jan 2014 Medical Device Safety Alert: St. Jude Medical ICDs and CRT-Ds programmed with Merlin Programmer Software Version 17.2.2 rev. 0
23 Jan 2014 Medical Device Safety Alert: Codman Neuro TRUFILL n-BCA Liquid Embolic System
22 Jan 2014 Medical Device Safety Alert: Tornier radial head prosthesis – MoPyC – Head
22 Jan 2014 Medical Device Safety Alert: Cell Search CELLTRACKS AUTOPREP System
22 Jan 2014 Medical Device Safety Alert: Synthes GmbH Midface Distractor, complete, distraction length 40 mm, Titanium Alloy (TAN)
22 Jan 2014 Medical Device Safety Alert: Miltenyi Biotec LIFE 18 apheresis system
20 Jan 2014 Safety alert on insulin cartridges of t:slim Insulin Pump
17 Jan 2014 Medical Device Safety Alert: Boston Scientific Atlantis PV 15 MHz Peripheral Imaging Catheter
14 Jan 2014 Medical Device Safety Alert: WEINMANN Medical Technology VENTIlogic LS ventilators
07 Jan 2014 Medical Device Safety Alert: Siemens ACUSON SC2000 Ultrasound Systems
07 Jan 2014 Medical Device Safety Alert: Carefusion Alaris PC unit
03 Jan 2014 Medical Device Safety Alert: International Technidyne Corporation Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes
31 Dec 2013 Medical Device Safety Alert: Edwards Lifesciences Femoral Arterial and Venous Cannula
30 Dec 2013 Medical Device Safety Alert: Orascoptic Endeavor Light System
24 Dec 2013 Medical Device Safety Alert: Stryker Neptune 2 Ultra Waste Management System
24 Dec 2013 Medical Device Safety Alert: Novacare ProLift S 222 Standsupport Slings
24 Dec 2013 Medical Device Safety Alert: Synthes SynReam Medullary Reamer Head Ø 8.5 mm
23 Dec 2013 Medical Device Safety Alert: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter
23 Dec 2013 Medical Device Safety Alert: BioMérieux VIDAS 3 system
20 Dec 2013 Medical Device Safety Alert: GE Healthcare Resuscitation Systems
18 Dec 2013 Medical Device Safety Alert: ALung Technologies Hemolung Cartridge
16 Dec 2013 Medical Device Safety Alert: Covidien Puritan Bennett 840 Ventilator
13 Dec 2013 Medical Device Safety Alert: Biosensors International Axxess Drug Eluting Coronary Bifurcation Stent System
13 Dec 2013 Medical Device Safety Alert: Baxter ABACUS Total Parenteral Nutrition Calculation Software
12 Dec 2013 Medical Device Safety Alert: HospiraPLUM LifeCare 5000 Series and PLUM XL Families of Infusers
11 Dec 2013 Medical Device Safety Alert: Bedfont Scientific NOxBOXi Inhaled Nitric Oxide Delivery and Monitoring Device
06 Dec 2013 Medical Device Safety Alert: Rudolf Medical GmbH laparoscopic instruments
04 Dec 2013 Safety alert on Philips HeartStart FRx and HeartStart HS1 automated external defibrillators
04 Dec 2013 Medical Device Safety Alert: 3M ESPE IMPRINT II Regular Body VPS Impression Material Refill
03 Dec 2013 Medical Device Safety Alert: Varian Eclipse Treatment Planning System and ARIA
03 Dec 2013 Medical Device Safety Alert: Fresenius Medical Care sleep safe sets
02 Dec 2013 Medical Device Safety Alert: Abbott RealTime High Risk HPV Assay and RealTime High Risk (HR) HPV m2000 system ROW Combined Application CD-ROM
30 Nov 2013 Medical Device Safety Alert: ACUITY Pro Coronary Sinus 9Fr Outer Guide Catheters
29 Nov 2013 Medical Device Safety Alert: Draeger Monitor Arm AC 3000
28 Nov 2013 Further recall of FreeStyle and FreeStyle Lite blood glucose test strips
28 Nov 2013 Medical Device Safety Alert: Medtronic CoreValve AccuTrak Delivery Catheter System
28 Nov 2013 Medical Device Safety Alert: Spacelabs Healthcare CAS I/II Absorbers installed in the BleaseSirius and BleaseFocus Anesthesia Workstations
26 Nov 2013 Further recall of selected lots of FreeStyle Lite blood glucose test strips
26 Nov 2013 Medical Device Safety Alert: ArjoHuntleigh Contoura 450 and Project Versions of 25000E/L Hospital Bed Frames
25 Nov 2013 Recall of certain lots of FreeStyle and FreeStyle Lite blood glucose test strips
25 Nov 2013 Medical Device Safety Alert: Abbott HT Connect Peripheral Guide Wires
22 Nov 2013 Medical Device Safety Alert: B. Braun Perfusor Space Infusion Pump and Battery Pack
22 Nov 2013 Medical Device Safety Alert: Horizons International TWISTER PLUS Rotatable Retrieval Device
20 Nov 2013 Safety alert on three Sorin pacemakers
20 Nov 2013 Safety alert over Lenscare SH-System Monatslinsen monthly contact lenses
20 Nov 2013 Medical Device Safety Alert: Sysmex Fully Automated Blood Coagulation Analyzer
18 Nov 2013 Medical Device Safety Alert: Hospira Venisystems Blood Bottle Pumpset with CAIR Clamp
18 Nov 2013 Medical Device Safety Alert: BioMérieux ZYM B reagent, API Listeria & API NH
13 Nov 2013 Medical Device Safety Alert: Boston Scientific Vessix Generator System
12 Nov 2013 Medical Device Safety Alert: PARI SOLE N / PARI SOLE N Tracheo Inhalation Devices
11 Nov 2013 Medical Device Safety Alert: Medtronic IN.PACT Amphirion Drug-Eluting Balloon
11 Nov 2013 Medical Device Safety Alert: Philips ADAC ARGUS Gamma Camera Systems
07 Nov 2013 Medical Device Safety Alert: Boston Scientific 13F/15F Navigator HD Ureteral Access Sheath Set
07 Nov 2013 Medical Device Safety Alert: Stryker Neurovascular GDC Coils, Transform, Excelsior SL-10/Excelsior 1018 and Neuroform EZ Stent
06 Nov 2013 Medical Device Safety Alert: Draeger Infinity Acute Care System in Neonatal Mode
06 Nov 2013 Medical Device Safety Alert: Baxter 15L Cycler Drainage Bag
05 Nov 2013 Medical Device Safety Alert: Hospira Gemstar Docking Station
05 Nov 2013 Medical Device Safety Alert: Roche Accu-Chek Aviva Combo Meter and Accu-Chek Performa Combo Blood Glucose Meter
04 Nov 2013 Medical Device Safety Alert: Abbott i-STAT PT/INR Cartridge
04 Nov 2013 Medical Device Safety Alert: Baxter HomeChoice Pro Automated Peritoneal Dialysis System
04 Nov 2013 Medical Device Safety Alert: Siemens E.cam and Symbia E systems
31 Oct 2013 Medical Device Safety Alert: Nipro Diagnostics TRUEtrack and TRUEbalance Blood Glucose Monitoring System
28 Oct 2013 Medical Device Safety Alert: Applied Medical Inzii 12/15mm Retrieval System
28 Oct 2013 Medical Device Safety Alert: Penumbra Neuron MAX Catheters
24 Oct 2013 Medical Device Safety Alert: King Systems Universal Flex2 Breathing Circuit
24 Oct 2013 Medical Device Safety Alert: Terumo Sarns Soft-Flow Aortic Cannulae and Sarns Venous Return Cannulae
22 Oct 2013 Medical Device Safety Alert: Weinmann MEDUMAT Transport Ventilator
22 Oct 2013 Medical Device Safety Alert: Terumo Anaconda ONE- LOK Bifurcate Body and Anaconda Bifurcate Body
21 Oct 2013 Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system, 230V
18 Oct 2013 Medical Device Safety Alert: St Jude Medical Amplatzer Atrial Septal Occluder
16 Oct 2013 Medical Device Safety Alert: GE Healthcare Discovery 670, Optima 640, Discovery NM630 and Brivo NM615
16 Oct 2013 Medical Device Safety Alert: Terumo COBE Spectra Bone Marrow Processing Set
16 Oct 2013 Medical Device Safety Alert: Sysmex Automated Haematology Analyser
16 Oct 2013 Medical Device Safety Alert: Baxter TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI-GUARD
16 Oct 2013 Medical Device Safety Alert: Cordis OPTEASE Retrievable Vena Cava Filter
16 Oct 2013 Medical Device Safety Alert: HeartSine Samaritan PDU 400
16 Oct 2013 Medical Device Safety Alert: Philips Expression Information Portal - IP5
16 Oct 2013 Medical Device Safety Alert: BioScience HYAcorp L, HYAcorp H 1000 and HYAcorp H-S 500
11 Oct 2013 Medical Device Safety Alert: Pressure relieving air mattresses and overlays
10 Oct 2013 Medical Device Safety Alert: Medtronic Model 8870 Software Application Card used in the 8840 N'Vision Clinician Programmer
07 Oct 2013 Medical Device Safety Alert: Invacare Power Wheelchairs
07 Oct 2013 Medical Device Safety Alert: Medtronic CareLink 2090 Programmer
07 Oct 2013 Medical Device Safety Alert: H&H Medical Emergency Cricothyrotomy Kit
04 Oct 2013 Medical Device Safety Alert: GE Healthcare B20, B30 & B40 Patient Monitors
02 Oct 2013 Medical Device Safety Alert: Edwards Lifesciences EMBOL-X Glide Protection System
02 Oct 2013 Medical Device Safety Alert: Afikim Breeze C Scooters
02 Oct 2013 Medical Device Safety Alert: GE Healthcare Precision 500D, Legacy, RFX, and SFX X-ray imaging systems
02 Oct 2013 Medical Device Safety Alert: Baxter INFUSOR, FOLFUSOR, and INTERMATE Portable Elastomeric Infusion Systems
25 Sep 2013 Medical Device Safety Alert: Abbott Medical Optics STAR Excimer Laser System
23 Sep 2013 Medical Device Safety Alert: Siemens MicroScan Synergies plus and MicroScan rapID/S Panels
23 Sep 2013 Medical Device Safety Alert: Baxter Dual Luer Lock Caps
17 Sep 2013 Medical Device Safety Alert: Fresenius Medical Care MultiFiltrate devices using software version 5.2
17 Sep 2013 Medical Device Safety Alert: Hospira Receptal System Liners and Canisters
10 Sep 2013 Medical Device Safety Alert: GE Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems
09 Sep 2013 Medical Device Safety Alert: Philips BrightView XCT
05 Sep 2013 Medical Device Safety Alert: Siemens MicroScan Synergies plus and MicroScan rapID/S plus Negative Panels
03 Sep 2013 Medical Device Safety Alert: Hospira Plum-Set IV Administration Sets
30 Aug 2013 MedicalMedical Device Safety Alert: Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs
28 Aug 2013 Medical Device Safety Alert: Pride Mobility R40PED Powerchair
27 Aug 2013 Medical Device Safety Alert: Baxter Healthcare EXACTAMIX Compounder EM2400 and EM1200
27 Aug 2013 Medical Device Safety Alert: Codman Neuro MedStream Programmable Infusion Pump
26 Aug 2013 Medical Device Safety Alert: Terumo Advanced Perfusion System 1, Sarns Modular Perfusion System 8000, and Sarns Perfusion System 9000
26 Aug 2013 Medical Device Safety Alert: Sterile Chlorohexidine Gluconate/Alcohol Swabs, Sterile Alcohol Swabs and Sterile Povidine Iodine Swabs distributed by Medical Industries Australia
23 Aug 2013 Medical Device Safety Alert: Terumo BCT Spectra Optia Apheresis System
21 Aug 2013 Medical Device Safety Alert: Synthes Bone Screws
20 Aug 2013 Medical Device Safety Alert: Vygon Protect-A-Line IV extension set
20 Aug 2013 Medical Device Safety Alert: Covidien Monoject Prefill Flush Syringe
16 Aug 2013 Medical Device Safety Alert: BD PrepStain Slide Processors
16 Aug 2013 Medical Device Safety Alert: Philips HeartStart XL defibrillator/monitor with M3516A batteries
16 Aug 2013 Medical Device Safety Alert: Biosensors BioMatrix NeoFlex
15 Aug 2013 Medical Device Safety Alert: Hospira Intravascular Administration Sets
15 Aug 2013 Medical Device Safety Alert: A. Menarini Diagnostics GlucoMen LX Sensor blood glucose test strips 50 count
14 Aug 2013 Medical Device Safety Alert: Tornier Aequalis Reversed II and Reversed Fracture impactors
13 Aug 2013 Medical Device Safety Alert: GE Healthcare Tec 6 and Tec 6 Plus Vaporizers
09 Aug 2013 Medical Device Safety Alert: Draeger Ceiling Supply Units [CSU 603X/ 803X]
08 Aug 2013 Medical Device Safety Alert: BioMérieux chromID S. aureus agar
07 Aug 2013 Medical Device Safety Alert: 3M Scotchcast Wet or Dry Cast Padding
07 Aug 2013 Medical Device Safety Alert: CircuLite SYNERGY Circulatory Support System
07 Aug 2013 Medical Device Safety Alert: HPC Healthline GN85 Violet Accelerator Free Nitrile Examination Gloves
05 Aug 2013 Medical Device Safety Alert: GE Healthcare ViewPoint 6
05 Aug 2013 Medical Device Safety Alert: AIMEDICS HypoMon Alarm Systems
01 Aug 2013 Medical Device Safety Alert: Durolane Injectable Hyaluronic Acid Syringes
01 Aug 2013 Medical Device Safety Alert: Advanced Sterilization Products STERRAD 100NX System cassettes
01 Aug 2013 Medical Device Safety Alert: Boston Scientific 4mm x 15mm small peripheral cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device, and 4mm x 15mm Flextome cutting balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Device
26 Jul 2013 Medical Device Safety Alert: Nestle Compat Nasogastric Feeding Tube
25 Jul 2013 Medical Device Safety Alert: Werfen ACL TOP Family Coagulation Systems
25 Jul 2013 Medical Device Safety Alert: LeMaitre Albograft Vascular Graft
19 Jul 2013 Medical Device Safety Alert: Medtronic Navigation StealthStation S7 and i7 Systems and Planning Station containing FrameLink Software Version 5.4
19 Jul 2013 Medical Device Safety Alert: Tracoe Mini 3.0mm Tube
19 Jul 2013 Medical Device Safety Alert: DePuy LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component
17 Jul 2013 Medical Device Safety Alert: SureScreen Diagnostics Oral Fluid Drug Screen Device Saliva Collector
17 Jul 2013 Medical Device Safety Alert: Opus Healthcare Lift Medical Adhesive Remover, 100 ml Bottle
09 Jul 2013 Medical Device Safety Alert: Ortho Clinical DiagnosticsORTHO BioVue System Cassettes
05 Jul 2013 Medical Device Safety Alert: GE Healthcare nuclear medicine systems
05 Jul 2013 Medical Device Safety Alert: Brainlab iPlan 3.0
05 Jul 2013 Medical Device Safety Alert: Elekta Digital Accelerators with Electrons and Beam Modulator MLCi/MLCi2
05 Jul 2013 Medical Device Safety Alert: Handicare Ibis Comfort wheelchair
03 Jul 2013 Medical Device Safety Alert: Medtronic Insulin Reservoirs used with Paradigm Insulin Pump
02 Jul 2013 Medical Device Safety Alert: Protac SenSit Chair
28 Jun 2013 Medical Device Safety Alert: Thermo Fisher Scientific Remel Vibrio cholerae Inaba agglutinating serum
25 Jun 2013 Medical Device Safety Alert: Instalert Multi‐Drug Multi‐Line Twist Screen Test Device and Instalert DOA Multi‐Drug Multi‐Line Screen Test Device, Saliva Collector
25 Jun 2013 Medical Device Safety Alert: Philips Allura Xper FD10/10
24 Jun 2013 Medical Device Safety Alert: GE Healthcare Infinia, VG, VG Hawkeye and Helix nuclear medical systems
24 Jun 2013 Medical Device Safety Alert: AirSep Impulse Elite OCD
20 Jun 2013 Medical Device Safety Alert: Respironics V60 Non-invasive Ventilators
20 Jun 2013 Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
20 Jun 2013 Medical Device Safety Alert: DePuy Synthes MedStream Programmable Infusion System
19 Jun 2013 Medical Device Safety Alert: Medtronic SynchroMed II and SynchroMed EL pumps
19 Jun 2013 Medical Device Safety Alert: Medtronic Sutureless Connector Intrathecal Catheter
19 Jun 2013 Medical Device Safety Alert: Endologix AFX Introducer System
18 Jun 2013 Medical Device Safety Alert: Medtronic Consulta CRT-P
18 Jun 2013 Medical Device Safety Alert: Synthes Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5
17 Jun 2013 Medical Device Safety Alert: Medtronic SynchroMed Implantable Infusion Pump
17 Jun 2013 Medical Device Safety Alert: Joline Short Term Acute Dialysis Catheters
17 Jun 2013 Medical Device Safety Alert: Bio-Rad IH-1000
14 Jun 2013 Medical Device Safety Alert: Ethicon Temporary Cardiac Pacing Wire
14 Jun 2013 Medical Device Safety Alert: Synthes Dynamic Locking Screw Stardrive
14 Jun 2013 Medical Device Safety Alert: Synthes Transpedicular Schanz Screw
14 Jun 2013 Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
13 Jun 2013 Medical Device Safety Alert: Integra LifeSciences Absorbable Collagen Sponge
13 Jun 2013 Medical Device Safety Alert: Medtronic Paradigm Insulin Infusions Sets
11 Jun 2013 Medical Device Safety Alert: CareFusion Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails infusion pumps
10 Jun 2013 Medical Device Safety Alert: Stryker Sonopet Console
05 Jun 2013 Medical Device Safety Alert: Baxter Healthcare Coiled Tube Infusors
05 Jun 2013 Sweden suggests prophylactic PIP breast implant removal
04 Jun 2013 Medical Device Safety Alert: Health & Life EZ Breathe Atomizer
31 May 2013 Medical Device Safety Alert: Boston Scientific RIGIFLEX II Single Use Achalasia Balloon Dilator
31 May 2013 Medical Device Safety Alert: Boston Scientific ALAIR Bronchial Thermoplasty Catheter
31 May 2013 Medical Device Safety Alert: Boston Scientific NephroMax High Pressure Nephrostomy Balloon Catheter and NephroMax High Pressure Nephrostomy Balloon Catheter Kit
27 May 2013 Medical Device Safety Alert: Verathon GlideScope Reusable GVL, AVL, and Ranger Blades
27 May 2013 Medical Device Safety Alert: Verathon GlideScope Reusable GVL and AVL Blades
24 May 2013 Medical Device Safety Alert: Boston Scientific Advanix Biliary Stent with NaviFlex RX Delivery System
22 May 2013 Medical Device Safety Alert: Hospira Primary Plumset
21 May 2013 Medical Device Safety Alert: Mentor breast implants
21 May 2013 Medical Device Safety Alert: B. Braun Easypump C-bloc RA OnDemand
21 May 2013 Medical Device Safety Alert: Codman CERTAS Programmable Valves
20 May 2013 Medical Device Safety Alert: Symbios Medical Products GoPump and GOBlock Rapid Recovery System kits
20 May 2013 Medical Device Safety Alert: HeartWare Ventricular Assist System, Controller
20 May 2013 Medical Device Safety Alert: Liko Standard SlingBar 450
14 May 2013 Medical Device Safety Alert: Baxter Healthcare Irrigation Sets [Product Codes: 2C4013 & 2C4030]
13 May 2013 Medical Device Safety Alert: Defibrillators/monitors used for external pacing with non-invasive transcutaneous pacemaker modules
10 May 2013 Medical Device Safety Alert: Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc CN10 (Gentamicin)
10 May 2013 Medical Device Safety Alert: Covidien Versaport Bladeless Optical 5mm Trocar with Fixation Cannula
08 May 2013 Medical Device Safety Alert: Synthes Guide Wire Ø 2.5 mm, with drill tip, length 300 mm, Cobalt-Chrome Alloy
08 May 2013 Medical Device Safety Alert: Synthes Soft Tissue Retractor, small, extendible
08 May 2013 Medical Device Safety Alert: Philips Pinnacle<sup>3</sup> software
08 May 2013 Medical Device Safety Alert: Stryker FL14E Rose Bed
08 May 2013 Medical Device Safety Alert: Cardinal Health Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit
08 May 2013 Medical Device Safety Alert: ArjoHuntleigh Alenti Lift and Hygiene Chair
07 May 2013 Medical Device Safety Alert: Ethicon LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier
06 May 2013 Safety alert on CoaguChek blood coagulation testing devices
03 May 2013 Medical Device Safety Alert: Retrievable inferior vena cava filters
03 May 2013 Medical Device Safety Alert: Philips Brilliance CT 64, Ingenuity Core and Ingenuity Core128 systems
29 Apr 2013 Medical Device Safety Alert: Terumo BCT Trima Accel Automated Blood Collection System
26 Apr 2013 Medical Device Safety Alert: Carefusion Alaris PC unit model 8015 with software version 9.12
26 Apr 2013 Medical Device Safety Alert: BD BBL DrySlide PYR Kit and BD BBL DrySlide Oxidase Kit
26 Apr 2013 Medical Device Safety Alert: Ethicon ENDOPATH Probe Plus ll Shafts
26 Apr 2013 Medical Device Safety Alert: Bayer HealthCare 25-foot DC power cables shipped with Medrad Veris MR Vital Signs Monitors
26 Apr 2013 Medical Device Safety Alert: Advanced Sterilization Products STERRAD CYCLESURE 24 Biological Indicators
24 Apr 2013 Recall of PTS Panels Glucose Test Strips (with photo)
24 Apr 2013 Medical Device Safety Alert: Integra NeuraGen Nerve Guide and NeuraWrap Nerve Protector
24 Apr 2013 Medical Device Safety Alert: Integra DuraGen Dural Graft Matrix, DuraGen Plus Dural Regeneration Matrix and DuraGen Suturable Dural Regeneration Matrix
23 Apr 2013 Medical Device Safety Alert: Covidien Medi-Trac Cadence Adult and Pediatric Radiotransparent Defibrillation Electrodes
23 Apr 2013 Medical Device Safety Alert: St Jude Medical Fortify ST Implantable cardioverter defibrillator
19 Apr 2013 Medical Device Safety Alert: DePuy Synthes Confidence Spinal Cement System Kit
19 Apr 2013 Medical Device Safety Alert: Cook Ireland Limited Zilver PTX Drug-Eluting Peripheral Stent
19 Apr 2013 Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillator
19 Apr 2013 Medical Device Safety Alert: TECHNIDATA TD-Synergy Blood Bank module connected to TD-Synergy (known as LIS connection)
18 Apr 2013 Medical Device Safety Alert: Respironics SealFlex Single Port Ribbed Mask (Infant)
18 Apr 2013 Medical Device Safety Alert: GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera
18 Apr 2013 Medical Device Safety Alert: GE Healthcare LOGIQ S7 and S8
18 Apr 2013 Medical Device Safety Alert: Thermo Fisher Scientific Streptex Group D Latex, Lot Number: 1154057
16 Apr 2013 Medical Device Safety Alert: Abbott Diabetes Care FreeStyle InsuLinx Blood Glucose Monitoring System
16 Apr 2013 Medical Device Safety Alert: Biomerieux VIDAS D-Dimer Exclusion II
16 Apr 2013 Medical Device Safety Alert: Synthes CMF Matrix Screws in Clips
16 Apr 2013 Medical Device Safety Alert: Synthes Handle, flexible
15 Apr 2013 Medical Device Safety Alert: Brainlab iPlan RT Dose version 4.0/4.1
15 Apr 2013 Medical Device Safety Alert: Stryker ShapeMatch Cutting Guides
10 Apr 2013 Safety alert on automated peritoneal dialysis system
10 Apr 2013 Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system(Patient At-Home Guide)
10 Apr 2013 Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)
10 Apr 2013 Medical Device Safety Alert: Power pac batteries supplied with Newport HT70/HT70 Plus ventilator
10 Apr 2013 Medical Device Safety Alert: Smiths Medical BCI Remote Alarm Cables
09 Apr 2013 Medical Device Safety Alert: Advanced Sterilization Products STERRAD 100S and STERRAD 200 systems
09 Apr 2013 Medical Device Safety Alert: Synthes Holding Clamps for Multi Vector Distractor
09 Apr 2013 Medical Device Safety Alert: Penlon Sigma Delta Vaporizer
09 Apr 2013 Medical Device Safety Alert: Thermo Fisher RemelStreptex Group D Latex Reagent
09 Apr 2013 Medical Device Safety Alert: Brainlab ExacTrac 5.x Patient Positioning System
08 Apr 2013 Medical Device Safety Alert: Varian RPM Respiratory Gating System
05 Apr 2013 Medical Device Safety Alert: Teleflex Rusch Belly Bag Urine Collection Bag with Hip Belt
05 Apr 2013 Medical Device Safety Alert: GE Healthcare Avance CS<sup>2</sup>
02 Apr 2013 Medical Device Safety Alert: Greiner Bio-One VACUETTE Safety Blood Collection Sets and Blood Collection Sets
28 Mar 2013 Medical Device Safety Alert: Detergent and disinfectant wipes used on reusable medical devices with plastic surfaces
27 Mar 2013 Recall of Multiload Radiopaque Cu375 intrauterine contraceptive devices (with photos)
27 Mar 2013 Medical Device Safety Alert: Spacelabs Anesthesia Workstations and Service Kits
27 Mar 2013 Medical Device Safety Alert: Medtronic Paradigm insulin infusion pumps
26 Mar 2013 Medical Device Safety Alert: Lifescan OneTouch Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+ blood glucose meters
26 Mar 2013 Medical Device Safety Alert: Advanced Sterilization ProductsSTERRAD200 SystemCarriage
25 Mar 2013 Safety alert on two automated external defibrillators
25 Mar 2013 Medical Device Safety Alert: Hospira Gemstar Infusion Pump
22 Mar 2013 Medical Device Safety Alert: Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire
22 Mar 2013 Medical Device Safety Alert: Hospira Infusion Pumps
20 Mar 2013 Medical Device Safety Alert: Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc AMP10 (Ampicillin)
19 Mar 2013 Medical Device Safety Alert: Symbios GOPump Elastomeric Infusion PumpKit
18 Mar 2013 Medical Device Safety Alert: Kimberly-Clark KIMGUARD Container Filters
13 Mar 2013 Medical Device Safety Alert: Roche NH3L on cobas c 501/502
12 Mar 2013 Medical Device Safety Alert: Boston Scientific subcutaneous implantable defibrillator system
08 Mar 2013 Medical Device Safety Alert: Mona Lisa CuT 380A intra-uterine contraceptive device
08 Mar 2013 Medical Device Safety Alert: BioMerieux Trepanostika TP recombinant
07 Mar 2013 Medical Device Field Corrective Action: Philips Xper Information Management system components and Calysto system components
06 Mar 2013 Medical Device Safety Alert: DePuy Specialist 2 Intramedullary Rod
05 Mar 2013 Medical Device Safety Alert: Baxter Peritoneal Dialysis Transfer Set
04 Mar 2013 Medical Device Safety Alert: Vascular Solutions Guardian II and Guardian II NC Hemostasis Valves
01 Mar 2013 Medical Device Safety Alert: Ad-Tech Medical Instrument Macro Micro Subdural Electrodes
28 Feb 2013 Medical Device Safety Alert: LifeScan OneTouch Select Control Solution
28 Feb 2013 Medical Device Safety Alert: Abbott MitraClip Mitral Valve Repair System
25 Feb 2013 Medical Device Safety Alert: Lumenis VersaCut Tissue Morcellator
25 Feb 2013 Medical Device Safety Alert: DePuy Limb Preservation System Diaphyseal Sleeve
22 Feb 2013 Medical Device Safety Alert: Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc NOR10 (Norfloxacin)
22 Feb 2013 Medical Device Safety Alert: HOYA One-Piece Intraocular Lenses
22 Feb 2013 Medical Device Safety Alert: Hospira Plum A+ Family of Infusers (Battery Not Fully Recharged)
21 Feb 2013 Recall of Restylane SubQ Lidocaine 2ml dermal filler
21 Feb 2013 Medical Device Safety Alert: Philips HeartStart XL+ Defibrillator/Monitor
21 Feb 2013 Medical Device Safety Alert: Hospira Plum A+ Family of Infusers (fluid shield- fluid ingress)
21 Feb 2013 Medical Device Safety Alert: Hospira Plum A+ Family of Infusers (Distal Occlusion Pressure Sensor Drift)
19 Feb 2013 Medical Device Safety Alert: Roche CoaguChek XS Pro
19 Feb 2013 Medical Device Safety Alert: Roche NaOHD and Hitergent Cassettes
19 Feb 2013 Medical Device Safety Alert: HeartWare HVAD Pump Implant Kit
18 Feb 2013 Medical Device Safety Alert: Medtronic Deep Brain Stimulation Lead Kits and Dystonia Kits
14 Feb 2013 Medical Device Safety Alert: St Jude Medical AMPLATZER TorqVue FX Delivery System
14 Feb 2013 Medical Device Safety Alert: SOOIL Dana Diabecare R Insulin Pump
08 Feb 2013 Medical Device Safety Alert: Covidien Endo GIA AutoSuture Universal Loading Unit 30mm-2.0mm
08 Feb 2013 Medical Device Safety Alert: MAQUET Heart-lung Machine HL 30
06 Feb 2013 Medical Device Safety Alert: Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc CPD10 (Cefpodoxime)
06 Feb 2013 Medical Device Safety Alert: Unihoist University Bath Hoist and University Bath Hoist Transporter
05 Feb 2013 Medical Device Safety Alert: Activa Vial Adapter for the Advantajet, Gentlejet, and Advantajet ES
05 Feb 2013 Medical Device Safety Alert: Hospira Plum A+ Family of Infusers (Fluid shield diaphragm out of specification)
05 Feb 2013 Medical Device Safety Alert: Hospira Plum A+ Family of Infusers (Broken distal occlusion pressure pin)
05 Feb 2013 Medical Device Safety Alert: Elekta Apex Collimator
05 Feb 2013 Medical Device Safety Alert: Animas 2020 Insulin Infusion Pump
29 Jan 2013 Medical Device Safety Alert: Sorin ISOLINE defibrillation leads
29 Jan 2013 Medical Device Safety Alert: Gambro Bloodlines in used with Integra and AK machines
29 Jan 2013 Medical Device Safety Alert: Hill-Rom Dynamis and Gerialit Beds with DEWERT electrical system
28 Jan 2013 Medical Device Safety Alert: Medtronic O-arm Imaging Systems
28 Jan 2013 Medical Device Safety Alert: Medtronic Symplicity Catheters
25 Jan 2013 Medical Device Safety Alert: Vycor Medical ViewSite Brain Access System
23 Jan 2013 Medical Device Safety Alert: BioMérieux VIDAS D-Dimer Exclusion II
23 Jan 2013 Medical Device Safety Alert: Sybron Dental Specialties TempSpan CMT
22 Jan 2013 Medical Device Safety Alert: DePuy ADEPT 12/14 Modular Head
22 Jan 2013 Medical Device Safety Alert: DePuy Confidence Spinal Cement System
22 Jan 2013 Medical Device Safety Alert: Beckman Coulter Navios flow cytometer
21 Jan 2013 Medical Device Safety Alert: Zoll Circulation, Inc. AutoPulse Resuscitation System Model 100
21 Jan 2013 Medical Device Safety Alert: Synthes Electric Pen Drive
17 Jan 2013 Medical Device Safety Alert: BD BBL Fildes Enrichment
15 Jan 2013 Recall of selected lots of two brands of Acuvue contact lenses
14 Jan 2013 Medical Device Safety Alert: SynCardia Companion External Battery
10 Jan 2013 Medical Device Safety Alert: Nova StatStrip and Nova StatSensor
10 Jan 2013 Medical Device Safety Alert: TSE neonatal stationary incubator
10 Jan 2013 Medical Device Safety Alert: Mentor Breast Implants, Winged Infusion Sets, and PSI‐TEC Tubing
09 Jan 2013 Medical Device Safety Alert: Hospira Plum A+ Family of Infusers
08 Jan 2013 Medical Device Safety Alert: Fisher and Paykel Reusable Breathing Circuit
04 Jan 2013 Medical Device Safety Alert: Hamilton Medical AG HAMILTON-T1 Ventilator
04 Jan 2013 Medical Device Safety Alert: Praxair Grab'n Go Vantage Portable Oxygen Cylinder Unit
28 Dec 2012 Medical Device Safety Alert: BD BBL Crystal Enteric/Nonfermenter ID Kit
24 Dec 2012 Medical Device Safety Alert: Covidien Pipeline Embolization Device
24 Dec 2012 Medical Device Safety Alert: Terumo Advanced Perfusion System 1
24 Dec 2012 Medical Device Safety Alert: Terumo Sarns Soft-Flow Aortic Cannulae
17 Dec 2012 Medical Device Safety Alert: Abbott Laboratories m2000sp instrument
14 Dec 2012 Medical Device Safety Alert: MLE forearm crutch ergo grip (tall and adult)
12 Dec 2012 Medical Device Safety Alert: BioRad IH-Com kit Full version
12 Dec 2012 Medical Device Safety Alert: DiaSorin Liaison Biotrin Parvovirus B19 IgM
12 Dec 2012 Medical Device Safety Alert: Roche COBAS TaqMan MTB Test Definition File v3.0 for use with AmpliLink 3.3
12 Dec 2012 Medical Device Safety Alert: CooperVision Encore 100 Toric Soft Contact Lens
11 Dec 2012 Medical Device Safety Alert: Sybron Dental 30mm LSX files
11 Dec 2012 Medical Device Safety Alert: Smiths Medical Logical Hemodraw Closed Blood Sampling Systems
11 Dec 2012 Medical Device Safety Alert: St. Jude Medical Accent SR and Accent DR pacemakers
11 Dec 2012 Medical Device Safety Alert: Bitmos sat 805 and sat 816 pulse oximeters
11 Dec 2012 Medical Device Safety Alert: Viterion V100 and V500 Telehealth Monitors
07 Dec 2012 Medical Device Safety Alert: Coopers Walking frames
07 Dec 2012 Medical Device Safety Alert: Philips IntelliVue Information Center and Philips IntelliVue Information Center iX
06 Dec 2012 Medical Device Safety Alert: Medpro AccuFlux Elastomeric Infusion Pump
06 Dec 2012 Medical Device Safety Alert: Bunnell Life Pulse High-Frequency Ventilator Patient Circuits
04 Dec 2012 Medical Device Safety Alert: Ethicon Endo-Surgery ENSEAL G2 Curved and Straight Tissue Sealer
03 Dec 2012 Medical Device Safety Alert: Verathon GlideScope GVL Video Laryngoscope Reusable Blades
30 Nov 2012 Medical Device Safety Alert: Philips HeartStart HS1 and HeartStart FRx Automatic External Defibrillators
29 Nov 2012 Medical Device Safety Alert: Draeger Medical Infinity Acute Care System Monitoring Solution using with DualHemo Mcable
28 Nov 2012 Medical Device Safety Alert: Oscor Bipolar Temporary Myocardial Heartwire
27 Nov 2012 Medical Device Safety Alert: Dexcom G4 PLATINUM Replacement Receiver Kit
23 Nov 2012 Medical Device Safety Alert: Wheat or grain-filled heat packs
22 Nov 2012 Medical Device Safety Alert: Etac Swift Mobil Shower Chair
22 Nov 2012 Medical Device Safety Alert: Varian 4D Integrated Treatment Console v10.2.3 and Bar-Code Conical Collimator v1.0
20 Nov 2012 Medical Device Safety Alert: Medtronic SynchroMed Implantable Infusion Pump
20 Nov 2012 Medical Device Safety Alert: Animas 2020, IR1200, IR1250 Infusion Pumps
19 Nov 2012 Medical Device Safety Alert: Greatbatch MOBICATH Bi-Directional Guiding Sheath
16 Nov 2012 Medical Device Safety Alert: Bausch & Lomb Disposable cannulas provided with Amvisc and Amvisc Plus Sodium Hyaluronate
14 Nov 2012 Medical Device Safety Alert: CareFusion Alaris GP Infusion System
14 Nov 2012 Medical Device Safety Alert: Nihon Kohden cardioLife defibrillator, TEC-5521K and TEC-5531K
13 Nov 2012 Medical Device Safety Alert: Philips TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace, GEMINI LXL, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore
07 Nov 2012 Medical Device Safety Alert: California Medical Laboratories Standard Rigid Tip Suction Wand
06 Nov 2012 Medical Device Safety Alert: GE PROCARE B20 and B40 Monitors
06 Nov 2012 Medical Device Safety Alert: Hospira Plum A+ Single Channel Family of Infusers
02 Nov 2012 Medical Device Safety Alert: Terumo Arterial and Cardioplegia Monitor for Sarns Modular Perfusion System 8000
02 Nov 2012 Medical Device Safety Alert: Terumo Sarns Modular Perfusion System 8000
02 Nov 2012 Medical Device Safety Alert: Terumo Sarns Centrifugal System, Control Module
01 Nov 2012 Medical Device Safety Alert: Zimmer Durom Acetabular Component
01 Nov 2012 Medical Device Safety Alert: OMNILife science Apex K2 Femoral Stem
01 Nov 2012 Medical Device Safety Alert: Cordis ExoSeal Vascular Closure Device
31 Oct 2012 Medical Device Safety Alert: Biomerieux chromID Strepto B Agar
31 Oct 2012 Medical Device Safety Alert: GE Resuscitation Systems with blender field upgrade installed in GE Giraffe and Panda Warmers
31 Oct 2012 Medical Device Safety Alert: Stryker Spring Arm
26 Oct 2012 Medical Device Safety Alert: Medical devices and medicinal products containing chlorhexidine
25 Oct 2012 Medical Device Safety Alert: Zimmer Trilogy Acetabular Cup products and Trilogy Spike Cup products
25 Oct 2012 Medical Device Safety Alert: Roche Cobas TaqScreen MPX Test, version 2.0
24 Oct 2012 Medical Device Safety Alert: International Technidyne Corporation ProTime3 Test Cuvettes
24 Oct 2012 Medical Device Safety Alert: Waters Corporation Mass Spectrometry Instruments
24 Oct 2012 Medical Device Safety Alert: Ventlab manual resuscitators
19 Oct 2012 Medical Device Safety Alert: Johnson and Johnson Temporary Cardiac Pacing Wires
19 Oct 2012 Medical Device Safety Alert: Ethicon Endo-Surgery PSX PROXIMATE Skin Staple Extractors
19 Oct 2012 Medical Device Safety Alert: TECHNIDATA TD-Synergy Software Version 11.31.C
19 Oct 2012 Medical Device Safety Alert: Philips Amplimat 5-Field Chamber
18 Oct 2012 Medical Device Safety Alert: Risk of Cardiac Strangulation Associated with Epicardial Pacemaker Leads Implanted in Paediatric Patients
17 Oct 2012 Medical Device Safety Alert: NIKKISO Hemodialysis Device DBB-06 and DBB-07
17 Oct 2012 Medical Device Safety Alert: Boston Scientific Encore 26 Advantage Kit
16 Oct 2012 Medical Device Safety Alert: Invacare I-Fit Shower Chair
12 Oct 2012 Medical Device Safety Alert: Ormco Zoo Master Pack 2E 3/16 Hvy Kangaroo
10 Oct 2012 Medical Device Safety Alert: Liko Bathing Chair
10 Oct 2012 Medical Device Safety Alert: Intravenous Connectors with One-way Valves
08 Oct 2012 Medical Device Safety Alert: Accutron Ultra PC% Cabinet Mount Flowmeters
04 Oct 2012 Medical Device Safety Alert: Armstrong Medical Heated Ventilator and CPAP Breathing Circuits
03 Oct 2012 Medical Device Safety Alert: Philips Practix33plus
03 Oct 2012 Medical Device Safety Alert: Philips HeartStart XL Defibrillator/ Monitor Battery M3516A
03 Oct 2012 Medical Device Safety Alert: GE Discovery NM/CT 670 System
27 Sep 2012 Medical Device Safety Alert: Mindray WATO EX-55 and WATO EX-65
25 Sep 2012 Medical Device Safety Alert: Pace Medical MICRO-PACE 4580
25 Sep 2012 Medical Device Safety Alert: Smith and Nephew Birmingham Hip Modular Heads
19 Sep 2012 Medical Device Safety Alert: HeartSine Samaritan PAD 300/PAD 300P Automated External Defibrillator
18 Sep 2012 Medical Device Safety Alert: Boston Scientific LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System
18 Sep 2012 Medical Device Safety Alert: CareFusion Alaris PC Unit Model 8000
14 Sep 2012 Medical Device Safety Alert: Newport HT70 and HT70 Plus Ventilators
14 Sep 2012 Medical Device Safety Alert: Silicone Tracheostomy Tubes
12 Sep 2012 Medical Device Safety Alert: Silicone Tracheostomy Tubes
11 Sep 2012 Medical Device Safety Alert: Power Adapter used in PARI SOLE N Inhalation Device
11 Sep 2012 Medical Device Safety Alert: Hospira LifeCare PCA Infusion System
11 Sep 2012 Medical Device Safety Alert: Home Aware Home-use HIV and STD Test Kits
11 Sep 2012 Medical Device Safety Alert: Bayer GLUCOFACTS DELUXE software version 3.01
10 Sep 2012 Medical Device Safety Alert: Boston Scientific Z°Flex-270 Steerable Sheath
06 Sep 2012 Medical Device Safety Alert: Siemens Rechargeable Hearing Aids Charger
05 Sep 2012 Medical Device Safety Alert: Baxter BURETROL Solution Set
04 Sep 2012 Medical Device Safety Alert: Volcano s5/s5i Imaging System Software Version 3.2.1/3.2.2
04 Sep 2012 Medical Device Safety Alert: Medtronic Screw Module used with the ATLANTIS and Premier Anterior Cervical Plate System
03 Sep 2012 Medical Device Safety Alert: Synthes Drill Bit and Adjustable Drill Stop
31 Aug 2012 Medical Device Safety Alert: Eclipse Treatment Planning Systems [Versions 8.9 & 10.0]
29 Aug 2012 Medical Device Safety Alert: Hill-Rom VersaCare Bed
29 Aug 2012 Medical Device Safety Alert: Pentron Clinical TempSpan CMT
29 Aug 2012 Medical Device Safety Alert: Elekta SL75/5 Linear Accelerator
24 Aug 2012 Medical Device Safety Alert: Covidien DUET™ TRS Universal Straight and Articulating Single Use Loading Units
24 Aug 2012 Medical Device Safety Alert: CareFusion Alaris Pump Module, Model 8100
23 Aug 2012 Medical Device Safety Alert: CareFusion Alaris Pump Module, Model 8100
22 Aug 2012 Medical Device Safety Alert: Hospira 100 mL Burette Set Convertible Pin, 77 inch
22 Aug 2012 Medical Device Safety Alert: Bioconnect Optiflow Anastomotic Connectors
21 Aug 2012 Medical Device Safety Alert: Respironics V60 Ventilator
20 Aug 2012 Medical Device Safety Alert: Varian Clinac, Trilogy, Novalis Tx and Unique jaw carriers
20 Aug 2012 Medical Device Safety Alert: Baxter Sterile Water for Irrigation 1000ml
17 Aug 2012 Medical Device Safety Alert: Terumo Advanced Perfusion System 1
17 Aug 2012 Medical Device Safety Alert: St. Jude Medical Riata and Riata ST Silicone Endocardial Leads
17 Aug 2012 Medical Device Safety Alert: Shanghai Shenfeng L-Gel Ultrasound Transmission Gel
16 Aug 2012 Medical Device Safety Alert: Baxter AUTOMIX Compounder System
14 Aug 2012 Medical Device Safety Alert: Risk of Entrapment of Patients in Hospital Beds
14 Aug 2012 Medical Device Safety Alert: Nihon Kohden defibrillators cardiolife TEC-8300K series
14 Aug 2012 Medical Device Safety Alert: BrainLab Cranial Navigation System – Standard Cranial Reference Array
10 Aug 2012 Medical Device Safety Alert: Covidien DGPHP RFA High-Power single use grounding pads and Cool-tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads)
08 Aug 2012 Medical Device Safety Alert: Smith and Nephew metal and PEEK suture anchors
08 Aug 2012 Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillator
07 Aug 2012 Medical Device Safety Alert: Vascutek Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented)
07 Aug 2012 Medical Device Safety Alert: Berlin Heart EXCOR® arterial cannula with graft CGRG-021
06 Aug 2012 Medical Device Safety Alert: Philips EasyDiagnost
06 Aug 2012 Medical Device Safety Alert: Ethicon Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories 33mm and Proximate® HCS Hemorrhoidal Circular Staple and Accessories 33mm
03 Aug 2012 Medical Device Safety Alert: Smiths Medical Medfusion Model 4000 Syringe Infusion Pump
02 Aug 2012 Medical Device Safety Alert: Respironics Trilogy 100, 200 and 202 Ventilators
02 Aug 2012 Medical Device Safety Alert: CareFusion Alaris PC Unit, Model 8015
31 Jul 2012 Medical Device Safety Alert: Pendiq® Digital Insulin Pen
31 Jul 2012 Medical Device Safety Alert: Changzhou Zhiye Pre-filled Syringes of Saline
25 Jul 2012 Medical Device Safety Alert: Animas Insulin Pump
25 Jul 2012 Medical Device Safety Alert: EMS Medical Neonatal and Paediatric Endotracheal Tube Clamp / Holder
23 Jul 2012 Medical Device Safety Alert: HARTMANN Disposable Surgical Gown Recall
23 Jul 2012 Medical Device Safety Alert: Stryker Australia Pty Ltd ABGII Modular Femoral Stem and Modular Neck
20 Jul 2012 Medical Device Safety Alert: Kerr Corporation Discovery Trays
20 Jul 2012 Medical Device Safety Alert: Ormco AEZ Mini Distal Cutter with Hold Long
19 Jul 2012 Medical Device Safety Alert: CareFusion EnVe® ventilator
18 Jul 2012 Medical Device Safety Alert: Covidien Shiley Reusable Cannula Cuffed Tracheostomy Tubes
17 Jul 2012 Safety alert on ear lubricant
17 Jul 2012 Medical Device Safety Alert: Portable dental X-ray units
17 Jul 2012 Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillator
17 Jul 2012 Medical Device Safety Alert: Smith & Nephew Dyonics Bonecutter Electroblade
16 Jul 2012 Medical Device Safety Alert: Westone Laboratories Oto-Ease® ear lubricant
13 Jul 2012 Medical Device Safety Alert: Nobel Biocare NobelProcera Abutment Zr for Straumann Bone Lvl NC 3.3
13 Jul 2012 Medical Device Safety Alert: Nobel Biocare NobelClinician Software
12 Jul 2012 Medical Device Safety Alert: Alere Triage Rapid Diagnostic Test System
12 Jul 2012 Medical Device Safety Alert: ArjoHuntleigh Encore, Chorus and Sara Plus Standing Aids
11 Jul 2012 Medical Device Safety Alert: Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile
11 Jul 2012 Medical Device Safety Alert: Philips Gemini, Precedence and Brilliance
10 Jul 2012 Medical Device Safety Alert: Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile
10 Jul 2012 Medical Device Safety Alert:Standard Diagnostics Bioline HIV and Malaria rapid test kits
09 Jul 2012 Medical Device Safety Alert: Maquet FLOW-i Anesthesia System C20, C30, C40
06 Jul 2012 Medical Device Safety Alert: Pace Medical MICRO-PACE™ dual-chamber temporary cardiac pacemaker, REF 4580
05 Jul 2012 Medical Device Safety Alert: BD PrepStain™ Diti 1.2 and Diti 1.2 upgrade kits
03 Jul 2012 Medical Device Safety Alert: ev3 Onyx Liquid Embolic System
03 Jul 2012 Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Electronic Patient Gas System
03 Jul 2012 Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Battery
03 Jul 2012 Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Central Control Monitor
03 Jul 2012 Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Centrifugal System
29 Jun 2012 Medical Device Safety Alert: Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers)
28 Jun 2012 Medical Device Safety Alert: GE Aestiva/5 7900 SmartVent
28 Jun 2012 Medical Device Safety Alert: Fresenius Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate
28 Jun 2012 Medical Device Safety Alert: ProTime Microcoagulation System
27 Jun 2012 Medical Device Safety Alert: Kerr AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume and AlgiNot Volume FS
27 Jun 2012 Medical Device Safety Alert: Boston Scientific Zoom Latitude Programmer/Recorder/Monitor
27 Jun 2012 Medical Device Safety Alert: St.Jude Medical Merlin@Home Transmitter
27 Jun 2012 Medical Device Safety Alert: MHRA updated recommendations for the management of patients implanted with metal-on-metal hip replacements
22 Jun 2012 Medical Device Safety Alert: Maquet Cardiovascular LLC FLOW-i Anaesthesia System
22 Jun 2012 Medical Device Safety Alert: Terumo Advanced Perfusion System 1, Sarns™ Modular Perfusion System 8000 and Sarns™ Modular Perfusion System 9000
22 Jun 2012 Medical Device Safety Alert: Brainlab iPlan RT Dose version 4.1
19 Jun 2012 United Kingdom final expert report on PIP breast implants published
19 Jun 2012 Medical Device Safety Alert: Mindray V Series Patient Monitors
15 Jun 2012 Medical Device Safety Alert: I-Flow On-Q Pump C-Cloc with Ondemand Bolus button
15 Jun 2012 Medical Device Safety Alert: Ethicon Endo-Surgery Ligaclip Extra ligating clip cartridges
12 Jun 2012 Medical Device Safety Alert: Cordis Fire Star™ Rx PTCA Dilatation Catheter
12 Jun 2012 Medical Device Safety Alert: Covidien Monoject™ Insulin Safety Syringe
11 Jun 2012 Medical Device Safety Alert: Trinity Biotech Captia™ Varicella-Zoster Virus IgG Kit
08 Jun 2012 Medical Device Safety Alert: Moog Microbore Administration Set and Epidural Administration Set
08 Jun 2012 Medical Device Safety Alert: Kerr Extrude Wash
07 Jun 2012 Medical Device Safety Alert: Anaesthetic machines and associated devices
07 Jun 2012 Medical Device Safety Alert:BD Preset™ Arterial Blood Collection Syringe
04 Jun 2012 Medical Device Safety Alert: Abbott ARCHITECT CA 19-9XR
04 Jun 2012 Medical Device Safety Alert: Nidek Medical Oxygen Concentrators
31 May 2012 Medical Device Safety Alert: Philips Practix Convenio Mobile X-ray System
30 May 2012 Medical Device Safety Alert: Edwards Swan-Ganz Catheters
29 May 2012 Medical Device Safety Alert: Natus Medical Olympic Cool-Cap® System
29 May 2012 Medical Device Safety Alert: Edwards Lifesciences Heart Valves
28 May 2012 Medical Device Safety Alert: Baxa Abacus Total Parenteral Nutrition Calculation Software
25 May 2012 Medical Device Safety Alert: Capatex Neonatal Endotracheal Tube SCP Clamp/Holders
24 May 2012 Medical Device Safety Alert: Moog Curlin Intravenous Administration Sets
23 May 2012 Medical Device Safety Alert: Biocompatibles Bead Block Embolization Agent
22 May 2012 Medical Device Safety Alert: Schiller Medical FRED easy & FRED easy Life Defibrillators
22 May 2012 Medical Device Safety Alert: Covidien Legendair™ and Supportair™ Portable Ventilators
21 May 2012 Medical Device Safety Alert: Boston Scientific Profile™ Single-Use Pediatric Snare
21 May 2012 Medical Device Safety Alert: Abbott Molecular Vysis FISH Pretreatment Reagent Kits, Paraffin Pretreatment Reagent Kits & Protease Vials
18 May 2012 Medical device alert on a blood glucose monitoring system
18 May 2012 Medical Device Safety Alert: Covidien, Roticulator™ Single Use Stapler
18 May 2012 Medical Device Safety Alert: Varian TrueBeam and TrueBeam STx Versions 1.0 through 1.5
17 May 2012 Medical Device Safety Alert: Endeavour Quad (4 X Point) Walking Stick
17 May 2012 Medical Device Safety Alert: Ormco Enlight Unidose
16 May 2012 Medical Device Safety Alert: DePuy Side Fire Needles, part of Confidence Spinal Cement System™
15 May 2012 Medical Device Safety Alert: BOMImed. Disposable Resuscitators
14 May 2012 Medical Device Safety Alert: Terumo Sarns™ Antegrade Cardioplegia Cannula
10 May 2012 Medical Device Safety Alert: Endoscope Accessory Holder
09 May 2012 Medical Device Safety Alert: Hager & Werken Brilliant Mouth Mirror No. 4
08 May 2012 Medical Device Safety Alert: Advanced Sterilization Products STERRAD® CYCLESURE® 24 Biological Indicators
07 May 2012 Medical Device Safety Alert: Hill-Rom Affinity® Four Birthing Bed
03 May 2012 Medical Device Safety Alert: DePuy Cemented, Polished and Cobalt Chromium Alloy Hip Stems
03 May 2012 Medical Device Safety Alert: Pioneer Surgical Nubac Trial Inserter – 43-TRL-INSERTER
03 May 2012 Medical Device Safety Alert: Elekta XVI R4.5 systems
03 May 2012 Medical Device Safety Alert: Hsin Ten Electro Reflex Energizer
03 May 2012 Medical Device Safety Alert: Invacare TDX SP Power Wheelchair
03 May 2012 Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillators, Model M3536A
30 Apr 2012 Field Safety Notice: BD Phoenix™ System Software and BD Phoenix™ Update Disks
30 Apr 2012 Field Safety Notice: Pace Medical MICRO-PACE™ dual-chamber temporary cardiac pacemaker, REF 4580
27 Apr 2012 Field Safety Notice: BD PrepMate™ Syringing Pipette
25 Apr 2012 Field Safety Notice: MEDRAD® Continuum Pump and Tubing Set
24 Apr 2012 Safety alert over Cameron Health SQ-RX Pulse Generators
23 Apr 2012 MHRA issues updates on the use of injectable dermal filler, Macrolane for breast augmentation
23 Apr 2012 Field Safety Notice: Smith & Nephew, Inc. Trauma Pins and Drills
23 Apr 2012 Field Safety Notice: Baxa EVA TPN bags
20 Apr 2012 Field Safety Notice: Elekta MLCi and MLCi2 radiation heads
20 Apr 2012 Field Safety Notice: Baxa EVA TPN bags
20 Apr 2012 Field Safety Notice: Ergolet Hera II Bathing and Toilet Chair
19 Apr 2012 Field Safety Notice: Other-Sonic Generic Ultrasound Transmission Gel
18 Apr 2012 Field Safety Notice: 4D Integrated Treatment Console (4DITC) versions 8.1.3 to 8.8
18 Apr 2012 Field Safety Notice: 4D Integrated Treatment Console (4DITC) v8.6 or 8.8 in combination with treatment planning systems
17 Apr 2012 Field Safety Notice: Damon 3MX Bicuspid Brackets
16 Apr 2012 MHRA Medical Device Alert: Oral swabs with a foam head
12 Apr 2012 Field Safety Notice: St. Jude Medical QuickSite® and QuickFlex® Left Ventricular CRT Leads [Models 1056T, 1058T, 1156T and 1158T]
12 Apr 2012 Field Safety Notice: IDEV Technologies SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F)
05 Apr 2012 Field Safety Notice: Animas OneTouch Ping Insulin Pump
03 Apr 2012 MHRA issued new advice about metal-on-metal total hip replacements: MITCH TRH acetabular cups/MITCH TRH modular heads (Finsbury Orthopaedics) implanted with uncemented Accolade femoral stems (Stryker Orthopaedics)
30 Mar 2012 Field Safety Notice: Smith & Nephew 560P High Definition Camera Control Unit
29 Mar 2012 Field Safety Notice: Bristol-Myers Squibb ViaSpan
23 Mar 2012 Field Safety Notice: Philips HeartStart XL+ (861290) Defibrillator/Monitor
22 Mar 2012 Field Safety Notice: Hospira GemStar™ Bolus Cord used with Gemstar™ Pump
21 Mar 2012 Field Safety Notice: Boston Scientific Imager II™ Angiographic Catheter (Peripheral Intervention)
21 Mar 2012 Field Safety Notice: Boston Scientific Imager™ II Catheter (Urology)
21 Mar 2012 Field Safety Notice: Terumo®Advanced Perfusion System 1
21 Mar 2012 Field Safety Notice: Philips HeartStart MRx monitor/defibrillator
21 Mar 2012 Field Safety Notice: Roche Process Systems Manager Software Version 2.02.02c
21 Mar 2012 Field Safety Notice: LifeScan OneTouch® Verio® IQ Blood Glucose Meters
20 Mar 2012 Field Safety Notice: Medtronic SynchroMed® II Pump
20 Mar 2012 Field Safety Notice: Varian Eclipse™ Treatment Planning System
20 Mar 2012 Field Safety Notice: Varian FastPlan treatment planning system
20 Mar 2012 Field Safety Notice: Brainlab BrainSCAN and iPlan RT treatment planning software versions
19 Mar 2012 Field Safety Notice: Varian Optical Guidance Platform (OGP) with Frameless Array Module HZ1/HZ6
16 Mar 2012 Field Safety Notice: Abbott Molecular HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0q
14 Mar 2012 Field Safety Notice: Medtronic ATLANTIS™ / PREMIER® / VERTEX® Adjustable Drill Stop
14 Mar 2012 Field Safety Notice: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm
14 Mar 2012 Field Safety Notice: Boston Scientific ICD TELIGEN, Model Nos.: F102, F103, F110, F111 and CRT-D COGNIS, Model Nos.: P107 and P108
09 Mar 2012 Field Safety Notice: B. Braun Infusomat Space Pump - US Version Infusion pump
09 Mar 2012 Field Safety Notice: Terumo CDI™ 500 Blood Parameter Monitoring System
09 Mar 2012 Field Safety Notice: Terumo Soft-Flow® Aortic Cannula with angled tip
08 Mar 2012 Field Safety Notice: BIOS Rollator
08 Mar 2012 Field Safety Notice: Etac Avant, Avant LW and Salsa
08 Mar 2012 Field Safety Notice: Soloist™ Single Needle Electrode
07 Mar 2012 Field Safety Notice: SD Bioline HIV-1/2 v3.0
07 Mar 2012 Field Safety Notice: Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0
07 Mar 2012 Field Safety Notice: 4D Integrated Treatment Console and TrueBeam
06 Mar 2012 Safety alert over certain Medtronic implantable cardioverter-defibrillators
06 Mar 2012 Field Safety Notice: HeartStart FR3 Automated External Defibrillators
06 Mar 2012 Field Safety Notice: Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)
05 Mar 2012 Recall of EUKARE Blood Glucose Test Strip
29 Feb 2012 MHRA updated recommendations for the management of patients implanted with metal-on-metal hip replacements
29 Feb 2012 Field Safety Notice: Scottcare TeleSentry Model TS01
28 Feb 2012 Field Safety Notice: SonRtip endocardial pacing lead with contractility sensor, model PS55D
28 Feb 2012 Field Safety Notice: Thoratec HeartMate II® Left Ventricular Assist System
23 Feb 2012 Field Safety Notice: SybronEndo K3 Gutta Percha
23 Feb 2012 Field Safety Notice: SybronEndo Buchanan Medium Pluggers
22 Feb 2012 Recall of Mylife Pura blood glucose strips in France
21 Feb 2012 Field Safety Notice: Biosense Webster Carto® 3 Systems
21 Feb 2012 Field Safety Notice: Helping Hand Turntable MK 6, Skyframe hoist system
16 Feb 2012 Field Safety Notice: The Nemschoff Perinatal Bassinet Products (Models: BSNT/01, BSNT/02, BSNT/03, BSNT/04)
14 Feb 2012 Field Safety Notice: Philips IntelliVue patient monitors
14 Feb 2012 Field Safety Notice: Salter Labs 7600 Bubble Humidifier Used with Supplemental Oxygen Therapy
14 Feb 2012 Field Safety Notice: Boston Scientific Wingspan™ Stent System with Gateway™ PTA Balloon Catheter
13 Feb 2012 Field Safety Notice: BD PrepStain™ Vacuum Pumps
09 Feb 2012 Field Safety Notice: Zoll Pedi-Padz Reduced Energy Electrode, Model # 8900-0401
06 Feb 2012 Field Safety Notice: Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B
01 Feb 2012 Field Safety Notice: Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System
01 Feb 2012 Field Safety Notice: Abbott Molecular Bar Code Scanner User's Guide
01 Feb 2012 Field Safety Notice: TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore
31 Jan 2012 Recall of Cardiac Science automated external defibrillators
31 Jan 2012 Statement on Metal-on-Metal Hip Replacement Implants issued by the Medicines and Healthcare Products Regulatory Agency (MHRA), UK
26 Jan 2012 Field Safety Notice: Recall of CareFusion Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License
26 Jan 2012 Field Safety Notice: Biomet Microfixation Sternalock Blu Implant Tray
26 Jan 2012 Field Safety Notice: Terumo CDI™ Blood Parameter Monitoring System 500
22 Jan 2012 Medical Device Safety Alert: Medicina NGP 6Fr – Nasogastric Feeding Tube
16 Jan 2012 Field Safety Notice: Recall of Covidien Duet TRS™ Universal Straight and Articulating Single Use Loading Units
13 Jan 2012 FDA Class I Recall: Respironics Trilogy 100 Ventilators
13 Jan 2012 Field Safety Notice: Terumo® Advanced Perfusion System 1
12 Jan 2012 Field Safety Notice: Given Imaging Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles)
10 Jan 2012 Recall of selected lots of ACUVUE® OASYS® with HYDRACLEAR® Plus Contact Lenses
10 Jan 2012 MHRA Field Safety Notice: SynCardia Companion 2 Driver System
09 Jan 2012 DH maintains vigilance over safety of PIP breast implants
04 Jan 2012 Field Safety Notice: HeartWare™ Ventricular Assist System
04 Jan 2012 Field Safety Notice: SynCardia Freedom Driver System
28 Dec 2011 Field Safety Notice: Sierra Scientific Instruments ManoShield™ AR
23 Dec 2011 Field Safety Notice: Smiths Medical Voluntary Recall for Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets
23 Dec 2011 Field Safety Notice: Johnson & Johnson Vision Care 1 Day Acuvue® TruEye™ (Narafilcon B) Contact Lenses
23 Dec 2011 Recommendation by the French authority on removal of PIP breast implants
22 Dec 2011 Adverse events related to Poly Implant Prothese breast implants
20 Dec 2011 Field Safety Notice: Update of the Instructions for Use of DLPR Single Stage Venous Cannulae
14 Dec 2011 Field Safety Notice: Amendments to instructions for use of CERAGEM-E Massage Bed
13 Dec 2011 Field Safety Notice: Smiths Medical Graseby MR10 Neonatal Respiration Monitor
08 Dec 2011 Field Safety Notice: Bausch & Lomb Crystalens® Accommodating Posterior Chamber Intraocular
07 Dec 2011 Safety alert over Lenscare SH- Monatslinsen contact lenses
06 Dec 2011 Field Safety Notice: 4Care AG's SH-System Monatslinsen contact lenses
06 Dec 2011 Field Safety Notice: Metrex Research Pinnacle Syringe Sleeves
05 Dec 2011 Field Safety Notice: CLR Medicals International Inc., Visco Supreme
02 Dec 2011 Field Safety Notice: Beavers Dental FG 1/2 Burs
02 Dec 2011 Field Safety Notice: Pentron Clinical Correct Plus Berry Putty Auto Mix
02 Dec 2011 Field Safety Notice: Pentron Clinical Artiste Nano-Hybrid Flowable Composite
02 Dec 2011 Field Safety Notice: Beavers Dental LA 5 Burs
29 Nov 2011 Field Safety Notice: Abbott Vascular RX Accunet Embolic Protection System
29 Nov 2011 Field Safety Notice: Sybron Dental Specialties Freedom Cordless LED Headlight
29 Nov 2011 Field Safety Notice: Cordis SUPER TORQUE® MB Angiographic Catheter
28 Nov 2011 Field Safety Notice: Medtronic Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006, 62000, 62006)
25 Nov 2011 Field Safety Notice: Varian C-Series Clinac® or Trilogy, versions 7.x and 8.x
25 Nov 2011 Field Safety Notice: Impulse Dynamics OPTIMIZER® III Implantable Pulse Generator
25 Nov 2011 Recall of Merz Aesthetics' Radiesse Dermal Filler
23 Nov 2011 Field Safety Notice: Terumo CVS Sarns™ Sternal Saw I System
23 Nov 2011 MHRA Field Safety Notice: Spacelabs Healthcare hook-up kits containing non-sterile alcohol prep pads
22 Nov 2011 MHRA Field Safety Notice: Mindray V series patient monitor
18 Nov 2011 Recall of FreshKon Airis 1-Month contact lenses
17 Nov 2011 Medical Device Recall: Coloplast Catheter Valve
17 Nov 2011 Field Safety Notice: Varian OBI 1.3, OBI 1.4; OBI 1.5; TrueBeam 1.0; Offline Review 1.0 - 2.0
17 Nov 2011 Field Safety Notice: Varian Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34)
16 Nov 2011 Recall of Avaira and BioComfort XO contact lenses
15 Nov 2011 Field Safety Notice: Brainlab BrainSCAN version 5.31 and 5.32
15 Nov 2011 Health Canada Type II Recall: SorinCRM Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)
15 Nov 2011 MHRA Field Safety Notice: Handicare Puma, Beatle, Alex and Ibis XP power wheelchairs
15 Nov 2011 Health Canada Type I Recall: Zevex Ambulatory Infusion PumpsPainsmart IOD, 6000 CMS, and 4000 CMS
15 Nov 2011 MHRA FSN Safety Alert: Spacelabs Healthcare ABP Monitor, Model 90217A
14 Nov 2011 Medical Device Recall: Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths
08 Nov 2011 Field Safety Notice: Varian TrueBeam and TrueBeam STx
02 Nov 2011 Safety alert over Abbott's FreeStyle InsuLinx Blood Glucose Monitoring System
01 Nov 2011 Product Recall: Synthes A2FN Reamer
31 Oct 2011 Field Safety Notice: Boston Scientific SCS Remote Control (RC), Charger, External Trial Stimulator, Trial Patient Belt & Charger Belt
28 Oct 2011 Field Safety Notice: Boston Scientific COGNIS®, TELIGEN®, INCEPTA™, PUNCTUA™, and ENERGEN™ CRT-Ds and ICDs, and LATITUDE® remote patient monitoring system
24 Oct 2011 Field Safety Notice: Drager Delta, Delta XL, Vista XL, Gamma XXL and Kappa
24 Oct 2011 Field Safety Notice: Immucor Gamma Complement Control Cells, lot 34161
21 Oct 2011 FDA Field Safety Notice: Cardiac Science Corporation Powerheart Automated External Defibrillator (AED) Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440.
21 Oct 2011 TGA Class II Recall: Oto-Ease ear lubricant
21 Oct 2011 FDA Class I Recall: CareFusion EnVe Ventilators
19 Oct 2011 Field Safety Notice: Elekta XVI 4.5 and 4.6
18 Oct 2011 Urgent Field Safety Notice: "Choice for Health" Various Bandages
18 Oct 2011 Field Safety Notice: Boston Scientific TWISTERTM Rotatable Polyp Retrieval Device
17 Oct 2011 Urgent Field Safety Notice: Eclipse™ electron Monte Carlo (eMC) Release 6.5 thru 8.9 (DCS build 7.5.XX thru 8.0.XX and DCF build 8.1.XX thru 8.9.17), and Eclipse Release 10.0 (DCF build 10.0.25 and 10.0.28)
14 Oct 2011 FDA Educational Materials: Decorative Contact Lenses
13 Oct 2011 Urgent Product Recall: BD Oral Syringe with Syringe Tip Caps
13 Oct 2011 Urgent Field Safety Notice: Abbott m2000sp Instrument
13 Oct 2011 Field Safety Notice: InfinityR Acute Care System (IACS) Monitoring Solution with software versions VG1, VG1.2 and VG1.3
11 Oct 2011 MHRA Field Safety Notice: Breathing System Components
11 Oct 2011 MHRA Field Safety Notice: Octopus-3 x Anti-reflux Valves + Clamps
07 Oct 2011 Urgent Field Safety Notice: Varian FrameArray Module HZ7 and Floorstand HZ5
06 Oct 2011 Health Canada Type II Recall: Warmair Model 134`
04 Oct 2011 Field Safety Notice: Hospira All Plum A+ family of Infusers
04 Oct 2011 Field Safety Notice: Synthes AnspachR Single-use Cutting Burs and Irrigation Clips
30 Sep 2011 Field Safety Notice: Terumo CVS CDI Blood Parameter Monitoring System 500
30 Sep 2011 MHRA Medical Device Alert: Reusable laryngoscope handles
28 Sep 2011 Voluntary Product Recall: Bausch & Lomb Soflens 59, lot W12010319
23 Sep 2011 Safety Alert on Two St Jude Medical's Pacemakers - Accent DR and Anthem CRT-P
23 Sep 2011 Urgent Field Safety Notice: Penlon CrystalR Metal Disposable Blades (Mac 3 and Mac 4)
22 Sep 2011 Field Safety Alert: Gemstar docking station (model number: 13075)
20 Sep 2011 FDA Class I Recall: Lee Medical International Inc., Custom Dialysis Trays/Kits
15 Sep 2011 Alert over an HIV home test kit
15 Sep 2011 Urgent Field Safety Notice: Clinac®, Trilogy®, Trilogy Tx™ and Novalis Tx™ Accelerators
14 Sep 2011 Voluntary Recall Notification: Cochlear Nucleus CI500 cochlear implant range
08 Sep 2011 Urgent Field Safety Notice: RT Chart function of ARIA™
07 Sep 2011 Field Safety Notice: Sarns™ Modular Perfusion System 8000: Cardioplegia Monitor
02 Sep 2011 FDA Class I Recall: Boston Scientific Innova™ Self-Expanding Stent System
31 Aug 2011 Field Safety Notice: Robinson Healthcare Cotton Gauze Tissue BP 45x90cm
30 Aug 2011 Product Recall: Abbott Diagnostics Clinical Chemistry Alkaline Phosphatase Reagent
29 Aug 2011 Urgent Field Safety Notice: Eclipse 10 (Client builds 10.0.28 and 10.0.34)
26 Aug 2011 Safety alert on ShoulderFlex massager
22 Aug 2011 Recall of Avaira Toric and BioComfort XO Toric contact lenses
20 Aug 2011 Suspend use of Avaira Toric daily contact lenses advisable
18 Aug 2011 Field Safety Notice: 4D Integrated Treatment Console (4DITC), version 8.1 SP2 to 10.1 SP1
18 Aug 2011 Medical Device Removal: Terumo Level Sensor II Pads
16 Aug 2011 Recall of Bayer's Contour and Contour TS Glucose Test Strips
15 Aug 2011 Medical Device Recall: Boston Scientific Expect™ Endoscopic Ultrasound Aspiration Needle
09 Aug 2011 Field Safety Notice: Boston Scientific Katzen™ Infusion Wire
05 Aug 2011 FDA Class I Recall: Arrow NextStep Antegrade Chronic Hemodialysis Catheter manufactured between April 14, 2011 and May 9, 2011
04 Aug 2011 Field Safety Notice: Use of Brainlab Skull Reference Base in combination with KLS Martin Cross-Drive screws
04 Aug 2011 Field Safety Notice: Philips Allura Xper Systems - Allura Xper FD10 (F/C), Allura Xper FD10/10 (incl. OR table), Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/20 and Allura CV20
04 Aug 2011 FDA Class I Recall: GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH) for Vital Signs Anesthesia Breathing Circuits
03 Aug 2011 FDA Class I Recall: GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System
29 Jul 2011 Recall of two Mona Lisa intrauterine contraceptive devices (with photo)
28 Jul 2011 Recall of Alterna® Sterile Post-Operative ostomy bags due to sterility problem
27 Jul 2011 Alert on product recall: Coseal Surgical Sealant
26 Jul 2011 Field Safety Notice: 4D Integrated Treatment Console v8.6 with ARIA RT Chart v8.5, all of 4DITC v8.3
20 Jul 2011 Field Safety Notice: Boston Scientific Resolution® II Clip
20 Jul 2011 Advisory Notice: Abbott Medical Optics (AMO) STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30
17 Jul 2011 Field Safety Notice: Thermo Fisher Scientific, Thermo Scientific Microm HM355S
17 Jul 2011 Field Safety Notice: Boston Scientific PROMUS ElementTM Everolimus-Eluting Coronary Stent System
14 Jul 2011 FDA Updates on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
14 Jul 2011 Alert on product recall: Banitore Basic Dressing Pack
11 Jul 2011 Field Safety Notice: Smith & Nephew, Tendon Stripper, slotted, 5.0 mm I.D. x 12” working length
08 Jul 2011 Field Safety Notice: Varian Eclipse Treatment Planning System: Eclipse Release 6.5 through 10 (versions 7.3.10 to 10.0.34), Model: H48
23 Jun 2011 Alert on performance of two automated external defibrillators
21 Jun 2011 Safety alert over Roche blood glucose strip
07 Jun 2011 Safety alert over certain Cameron pulse generators
23 May 2011 Recall of Braunoderm disinfectant solution
04 May 2011 Alert on voluntary recall and corrective action by Defibtech on semi-automatic external defibrillators
15 Apr 2011 Recall of microbial contaminated protective wipes and adhesive removers
02 Mar 2011 Safety alert on ACCU-CHEK FlexLink Plus infusion sets
11 Feb 2011 Safety concern on Fraxel re:store Dual Laser System
07 Feb 2011 Additional Health Products Co-Packaged with Recall Alcohol Pre Pads
27 Jan 2011 Serious safety concern on some Medico implantable pacemakers
14 Jan 2011 Shandex Sales Group Urgently Recalls Alcohol Swabs
11 Jan 2011 Resumption of Sale of Abbott's Optium Omega glucose test strips
07 Jan 2011 Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination
29 Dec 2010 Blanket recall of Abbott glucose test strips
23 Dec 2010 Recall of Abbott's Glucose Test Strips
27 Oct 2010 Further Recall of Single-Use Contact lenses
20 Aug 2010 Contact lens problems
19 Aug 2010 Voluntary Recall of Single-Use Contact Lenses
11 Aug 2010 Recall of automated peritoneal dialysis system
31 Jul 2010 Caution on Novabel Dermal Filler
09 Jun 2010 Software defect may cause malfunction in implantable cardioverter-defibrillator
01 Jun 2010 Recall of automated external defibrillators
06 May 2010 Software defect causes malfunction in implantable cardioverter-defibrillator
05 May 2010 Software Defects Cause Malfunctioning in Medtronic's Implantable Cardiac Devices
31 Mar 2010 Recall of silicone-filled breast implants
12 Feb 2010 Recall of LifeScan OneTouch SureStep blood glucose test strips with incorrect readings
18 Nov 2009 Field Correction of Automated External Defibrillators
08 Sep 2009 Heartbeat Regulating Products with Low-voltage Problem
19 May 2009 Follow-up Action on Medtronic Kappa and Sigma Pacemakers
24 Apr 2009 Recall of Automated External Defibrillators
23 Apr 2009 Recall of blood glucose meters with incorrect readings (i-sens Model CareSens II)
23 Apr 2009 Voluntary recall of device containing non-sterile radioactive material
15 Oct 2007 Voluntary Suspension of Defibrillation Leads
11 Sep 2007 Medical Device Alert for Blood Glucose Meters
26 May 2007 Recall of AMO Contact Lens Solution
25 Apr 2007 Recall of Medical Device for Treatment of Temporary Stoppage of Breathing during Sleep (CPAP Machines)
13 Apr 2007 Advisory Notice on Use of Heartbeat Regulating Products
19 Dec 2006 DH Closely Monitoring Safety of Lifescan Blood Glucose Meter
23 Nov 2006 DH and Customs Keep Close Watch on Recall of Contact Lens Solutions
22 Nov 2006 DH Monitoring Recall of Four AMO Contact Lens Solutions
19 Oct 2006 Software Problem Found in Programming Devices for Implantable Pacemakers
27 Jun 2006 Voluntary Recall of Heartbeat Regulating Products
16 May 2006 Update on cases of fungal corneal infections
03 May 2006 Update on cases of fungal corneal infections
24 Apr 2006 Bausch & Lomb withdraws ReNu with MoistureLoc contact lens solution from the USA
24 Apr 2006 Update on advice for prevention of fungal corneal infections
13 Apr 2006 Seek professional medical advice before breast augmentation
13 Apr 2006 Update on cases of fungal corneal infections
04 Mar 2006 Update on cases of fungal corneal infections
22 Feb 2006 DH keeps close watch on fungal corneal infections in Singapore
18 Feb 2006 Public reminded to clean contact lens properly
18 Jan 2006 DH notified of intra-uterine contraceptive device cases
05 Sep 2005 LifeScan Voluntarily Removes and Replaces Certain Blood Glucose Monitoring Products
22 Jul 2005 The United States Food and Drug Administration Announces Recall of Baxter Healthcare's Colleague Volumetric Infusion Pumps
12 Jul 2005 MHRA Alert: Styrene polymer based surgical and examination gloves may disintegrate when in contact with certain solvent
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