| 13 May 2024 |
Boston Scientific Corporation Expo 5F Selective Angiographic Catheters |
|
| 13 May 2024 |
Arrow International LLC Subsidiary of Teleflex Incorporated Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits |
|
| 13 May 2024 |
Exactech Inc Optetrak Three Peg Patella 26mm - 41mm |
|
| 13 May 2024 |
Becton Dickinson and Company BD SARS-CoV-2 Reagents for BD MAX Systems |
|
| 13 May 2024 |
Wishbone Medical, Inc. WishFIX Growth Control Plating System |
|
| 13 May 2024 |
TriMed Inc. TriMed, Threaded IM Nail |
|
| 13 May 2024 |
MEGADYNE Initiates Global Discontinuation and Voluntary Recall of MEGA SOFT Pediatric Patient Return Electrode |
|
| 13 May 2024 |
MEDLINE INDUSTRIES, LP - Northfield namic CONVENIENCE KIT [Multiple ref numbers; Multiple lot numbers] |
|
| 13 May 2024 |
Medtronic Perfusion Systems Medtronic Arterial Cannulae [Multiple model numbers; Multiple lot numbers] |
|
| 13 May 2024 |
Stryker Synchro Guidewire |
|
| 13 May 2024 |
Medtronic Navigation, Inc Stealth S8 Clinical Software Application |
|
| 10 May 2024 |
UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication |
|
| 10 May 2024 |
Stryker Connected OR Cart, 230V [Part number: 0240099156; Serial numbers: Multiple; GTIN: 07613327504101] |
|
| 10 May 2024 |
Vision RT Ltd (Sponsored by Vision RT Australia Pty Ltd) AlignRT Plus [Multiple Serial Numbers], AlignRT [UDI number: 5056190500337], AlignRT Offline [UDI number: 5056190500610] |
|
| 10 May 2024 |
Verathon Medical (Canada) ULC (Sponsored by Verathon Medical Australia Pty Ltd) GlideScope Core 15 and GlideScope Core 15 FHD Monitors [Part Numbers: 0570-0404 and 0570-0437; Software Versions: v1.9 and earlier for Core 15 and v1.7 and earlier for Core 15 FHD] |
|
| 10 May 2024 |
Canadian Hospital Specialties Ltd. Doing Business As CHS MED-RX Epidural Anesthesia Kit [Model or catalog number: 80-8169; Lot or serial number: 191306] |
|
| 10 May 2024 |
Medline Industries, LP Luer Slip Disposable Syringe Without Needle [Model or catalog number: SYR101020; Lot or serial number: All lots.], Syringe, Luer Lock [Model or catalog number: SYR101010; Lot or serial number: All lots.] |
|
| 10 May 2024 |
Stryker Leibinger GmbH & Co. KG Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM [Catalog Number: 56-90614; GTIN: 07613327123197; Lot Number: 270644] |
|
| 10 May 2024 |
上海上醫康鴿醫用器材有限責任公司 輸卵管導管 [涉及產品型號規格: PE型F5.5, PE型F5; 識別信息: 批號: 20240101, 20240102], 一次性使用吸痰管 [涉及產品型號規格: III型30F; 批號: 20231204] |
|
| 10 May 2024 |
Ortho-Clinical Diagnostics 奧森多臨床診斷(英國)有限責任公司 人類免疫缺陷病毒抗原及抗體聯合檢測質控品 [涉及產品型號、規格: 水平5 (HIV p24抗原): 9x1.2ml; 識別信息: 批次: 90, 100, 120, 130, 140,150, 160, 170, 180, 190, 200, 210, 及未來放行批次] |
|
| 10 May 2024 |
上海普洛麥格生物産品有限公司 高危型人乳頭瘤病毒(14個型)核酸分型檢測試劑盒(PCR-熒光探針法) [批號：0000513819; 批號：0000515860; 批號：0000546732; 批號：0000569384] |
|
| 10 May 2024 |
因美納股份有限公司 (Illumina, Inc.) 基因測序儀 (型號：NextSeq 550Dx和MiSeqDx) |
|
| 09 May 2024 |
GE Medical Systems, SCS GE Healthcare Innova IGS 5, IGS 6, Interact Discovery RT, Allia IGS 7, Allia IGS 7 OR, Allia IGS 5 Pulse, Allia IGS 5 Pulse |
|
| 09 May 2024 |
NRT X-RAY A/S Intelli-C: Right side suspended Tabletop, Left side suspended Tabletop |
|
| 09 May 2024 |
ICU Medical Inc (Sponsored by ICU Medical Australia Pty Ltd) Batteries Supplied by CSB and Used with Plum Infusion Systems - Plum 360 Infusion System, Plum A+ & Plum A+3 Infusion Systems |
|
| 09 May 2024 |
辛蒂思有限公司 Synthes GmbH 創傷外科手術器械包 Instruments for Trauma Surgery |
|
| 09 May 2024 |
Smith & Nephew, Inc. OXINIUM FEMORAL HEAD 12/14 32MM +4 |
|
| 09 May 2024 |
愛德華茲生命科學有限責任公司 Edwards Lifesciences LLC 幹式主動脈瓣膜 EDWARDS INSPIRIS RESILIA Aortic Valve |
|
| 09 May 2024 |
Alcon Laboratories, Incorporated Alcon Ophthalmic Knife, Alcon Ophthalmic V-Lance Knife, Clearcut S Safety Sab Sideport Knife |
|
| 09 May 2024 |
Integra Pain Management Integra Cranial Kit [Model or catalog number: INS-5HND; Lot or serial number: 7275713, 7289690] |
|
| 09 May 2024 |
Oxygenator Devices Used for Extracorporeal Circulation - Letter to Health Care Providers |
|
| 09 May 2024 |
Tandem Diabetes Care, Inc. t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology (version 2.7 or later /UDI: 00850006613274) |
|
| 09 May 2024 |
法國索菲薩 SOPHYSA 顱內壓探頭 [涉及產品型號、規格及批次: PSO-VT, PSO-VTT] |
|
| 09 May 2024 |
Vyaire Medical GmbH Vyaire Medical Twin Tube Probenschlauch |
|
| 09 May 2024 |
Stryker Medical Stryker ProCuity Beds [Model or catalog number: 3009PX-LE-400, 300900000000, 3009QC-P1, 3009PX-LEX-400] |
|
| 09 May 2024 |
Leica Biosystems Nussloch GmbH HistoCore Arcadia H [Model or catalog number: 14039354100] |
|
| 09 May 2024 |
Tandem Diabetes Care, Inc. Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion |
|
| 09 May 2024 |
Safety and Quality Concerns with Getinge Cardiovascular Devices - Letter to Health Care Providers |
|
| 08 May 2024 |
GE Medical Systems Israel, Functional Imaging MyoSPECT |
|
| 08 May 2024 |
Cardinal Health Presource Kits Containing Curity Flexible Adhesive Bandage X-large Components |
|
| 08 May 2024 |
Resmed Pty Ltd AirSense 11 devices |
|
| 08 May 2024 |
Medline Industries, LP Control Syringe Fixed Male Luer Lock |
|
| 08 May 2024 |
Arrow International LLC Subsidiary Of Teleflex Incorporated Ultra Intra-Aortic Balloon Pumps (IABP) |
|
| 07 May 2024 |
Philips Healthcare (Suzhou) Co., Ltd. Incisive CT System [Model or catalog number: 728144] |
|
| 07 May 2024 |
MED-EL Elektromedizinische Geraete GmbH 1) Mi1250 SYNCHRONY 2 Flex (26) [Model or catalog number: 39575]; 2) Mi1250 SYNCHRONY 2 Flex (28) [Model or catalog number: 39573] |
|
| 07 May 2024 |
Stryker Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 |
|
| 07 May 2024 |
Fresenius USA, Inc. Blood Pump Rotor (Spare Part) Used For 2008T Hemodialysis System CDX, Blood Pump Rotor (Spare Part) Used For Fresenius 2008T Hemodialysis System, Blood Pump Rotor (Spare Part) Used For K@Home |
|
| 07 May 2024 |
GE Healthcare Finland Oy CARESCAPE Monitoring System |
|
| 06 May 2024 |
SPINEART SA PERLA TL 25D SCREW |
|
| 06 May 2024 |
Hologic, Inc BioZorb Marker-BioZorb 3D Bioabsorbable Marker |
|
| 06 May 2024 |
Baxter Healthcare Corporation Baxter Spectrum IQ Infusion Pump |
|
| 06 May 2024 |
Angiodynamics, Inc. DURAFLOW 2, DURAMAX STACKED TIP, and BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit |
|
| 06 May 2024 |
Rhino Consultants and Facilitators Pvt Ltd (Sponsored by Haines Medical Australia Pty Ltd) Haines Air Assisted Transfer Mattress |
|
| 04 May 2024 |
Covidien LLC EsoFLIP Dilation Catheter 30mm [Model or catalog number: ES-330; Lot or serial number: 23D0777JZ, 22K0746JZ] |
|
| 04 May 2024 |
Philips Medical Systems Nederland B.V. MR systems with software version R5.7.1 |
|
| 04 May 2024 |
Philips Medical Systems Nederland B.V. MR systems |
|
| 04 May 2024 |
Johnson & Johnson Surgical Vision, Inc. Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge [REF: OPOHF21L] |
|
| 04 May 2024 |
Siemens Healthcare Pty Ltd IMMULITE 2000 and IMMULITE 2000 XPi Anti-TG Ab [Catalogue #: L2KTG2/10381659/ 00630414962108; Lot #: 782, 783, 786, 787, 788, 789, 791, 792, 793] |
|
| 04 May 2024 |
Canadian Water Technologies Ltd. Purified Water Storage And Delivery Component [Model or catalog number: CWTSDHDSSHI; Lot or serial number: All lots] |
|
| 04 May 2024 |
GE Healthcare IITS USA Corp Also Doing Business As GE Healthcare Centricity Anesthesia and Centricity High Acuity Anesthesia [Model or catalog number: M88021FD, K1900ECED, 5854438-004, K1900EJED] |
|
| 04 May 2024 |
BD Switzerland Sarl Alaris Pump Infusion Set Low Sorbing Tubing (Pe Lined) Back Check Valve 2 SmartSite™ Y-site(s) [Model or catalog number: 10013072; Lot or serial number: 22115368] |
|
| 04 May 2024 |
SEDECAL SA Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1 |
|
| 03 May 2024 |
Medtronic Minimed (Sponsored by Medtronic Australasia Pty Ltd) MiniMed 780G [Model Number: ACC-1527; Catalogue Numbers: MMT-1885 (R&D hardware packaging A2.xx), MMT-1895 (R&D hardware packaging A2.xx)] |
|
| 03 May 2024 |
Bayer Inc. Hydrasense Baby Nasal Care Easydose [Model or catalog number: 056219998997, 056219261282, 056500372369; Lot or serial number: G239889, G238402] |
|
| 03 May 2024 |
Innomed, Inc. INNOMED CUP REMOVAL STARTER INSTRUMENT [REF 520054; UDI/DI: 00840277104007; Lot Number: 1223K] |
|
| 03 May 2024 |
Respironics Inc. Also Trading As Philips Rs North America LLC Philips Respironics BiPAP and Humidifiers |
|
| 03 May 2024 |
Noah Medical Galaxy System [REF: GAL-001] |
|
| 02 May 2024 |
Medtronic Limited Esoflip dilation catheter 30mm – Model # ES-330 |
|
| 02 May 2024 |
Covidien Medtronic Invos [PM7100] |
|
| 02 May 2024 |
Elekta Instrument AB Disposable Biopsy Needle (911933) - Leksell Neurosurgical Instruments |
|
| 02 May 2024 |
"IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in. Prime BL1 C17/3 [Article Number: 758434; UDI-DI: (01)07615208438703, (11)231117, (10)Z063MW, (241)758434, (01)07615208438703, (11)231214, (10)Z067JD(241)758434; Lot Numbers: Z063MW, Z067JD] IPS e.max ZirCAD CER/in. Prime A1 C17/5 [Article Number: 758437; UDI-DI: (01)07615208438673, (11)231214, (10)Z067J5, (241)758437; (01)07615208438673, (11)231214, (10)Z067J6, (241)758437; (01)07615208438673, (11)240112, (10)Z06CBD, (241)758437; (01)07615208438673, (11)240112, (10)Z06CBF, (241)758437; Batch No. Z067J5, Z067J6, Z06CBD, Z06CBF], IPS e.max ZirCAD CER/in. Prime A2 C17/5 [Article Number: 758438; UDI-DI: (01)07615208438666, (11)231117, (10)Z063MX, (241)758438; (01)07615208438666, (11)231214, (10)Z067JH, (241)758438; (01)07615208438666, (11)240105, (10)Z06B6Y (241)758438; (01)07615208438666, (11)240118, (10)Z06D4N, (241)758438; Batch No. Z063MX, Z067JH, Z067J9, Z06B6Y, Z06D4N] IPS e.max ZirCAD CER/in. Prime A3 C17/5 [Article Number: 758439; UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439; (01)07615208438659 (11)231214 (10)Z067JF (241)758439; (01)07615208438659 (11)231214 (10)Z067JC (241)758439; (01)07615208438659 (11)231214, (10)Z067JG, (241)758439; (01)07615208438659, (11)231214, (10)Z067JB, (241)758439; (01)07615208438659, (11)240105, (10)Z06B6Z (241)758439; (01)07615208438659, (11)240112, (10)Z06CBG, (241)758439; Batch No. Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG], IPS e.max ZirCAD CER/in. Prime B1 C17/5 [Article Number: 758441; UDI-DI: (01)07615208438635, (11)231130, (10)Z065M0, (241)758441; (01)07615208438635, (11)240112, (10)Z06CBH, (241)758441; Batch No. Z065M0, Z06CBH], IPS e.max ZirCAD CER/in. Prime C2 C17/5 [Article Number: 758443; UDI-DI: (01)07615208438611, (11)231130, (10)Z065M1, (241)758443; Batch No.: Z065M1] " |
|
| 02 May 2024 |
Covidien, LP Sofsilk Braided Silk sutures [Product Number: S-2782K; UDI-DI: 20884521086422; Lot number: D2F2101RY] |
|
| 02 May 2024 |
"Allergan Sales, LLC Keller Funnel 2 [REF: HA-001; UDI: 10888628043725 / Lot number: 23B35C, 23B41C, 23B42C, 23C05C, 23C06C, 23D01C] " |
|
| 02 May 2024 |
Philips Medical Systems Nederland B.V. Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems [Multiple model numbers, product codes, device identifiers and software versions] |
|
| 02 May 2024 |
Cadwell Industries, Inc. Cascade IOMAX Cortical Module [Model No.: 190296-200; UDI/DI: 00840067100653,; Serial No.: 19029603AA0124014, 19029603AA0224009] |
|
| 02 May 2024 |
Maquet GmbH & Co KG (Sponsored by Getinge Australia Pty Ltd) Alphamaxx Operating Tables [Item number: 113322B4; Serial numbers: 3018-3078, 3080-3086, 3088, 3089, 3095-3097; Item number: 113322B5; Serial numbers: 2059-2118, 2119, 2120-2183, 2185-2204, 2206, 2208, 2209, 2211-2231. 2233, 2235; Item number: 113322F5; Serial numbers: 409-411, 413-416] |
|
| 02 May 2024 |
Medline International France Electrosurgical Electrode |
|
| 02 May 2024 |
HORIBA ABX SAS (HORIBA Medical) ABX Pentra Urea CP reagent (A11A01641/ 1220001641) for use on Pentra C200, ABX Pentra 400 and Pentra C400 |
|
| 02 May 2024 |
Aesculap AG (B Braun Medical Ltd) VITELENE INSERT F 32MM POST.WALL & VITELENE INSERT F 36MM POST.WALL [Part number(s): NV302E; NV315E; Affected serial or lot number: 52883304 (NV302E) ; 52882149 (NV315E)] |
|
| 02 May 2024 |
ACE Medical devices PVT. LTD. Ace Bladder Evacuator [Device Catalogue/ REF No.: ABVac; Basic UDI-DI: 890414810BECL] |
|
| 02 May 2024 |
Intuitive Surgical, Inc. 8 mm Bladeless Obturator (Box of 24) (Part Number: 420023-03); Arm Drape (Box of 20) (Part Number: 470015-07); 5 mm - 8 mm Cannula Seal (Box of 10) (Part Number: 470361-08); SureForm Stapler 45 (Box of 6) (Part Number: 480445-04); SureForm Stapler 60 (Box of 6) (Part Number: 480460-09) |
|
| 02 May 2024 |
Advanced Research Medical, LLC Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4 |
|
| 02 May 2024 |
Alere San Diego, Inc. Abbott Cholestech LDX Battery Kit [Model: 3LP656194-PCM-LD; PN: 55170] |
|
| 02 May 2024 |
美國FDA Encourages the Public to Follow Established Choking Rescue Protocols: 美國FDA Safety Communication |
|
| 02 May 2024 |
AusDiagnostics Pty Ltd Respiratory Pathogens B 16-well Step 2 Plates and Step 1 tubes, Respiratory Pathogens C 16-well Step 2 Plates and Step 1 tubes, Respiratory Pathogens 12-well Step 2 Plates and Step 1 tubes, Respiratory Pathogens 16-Well Step 2 Plates and Step 1 tubes, SARS-CoV-2, Influenza and RSV 8-well Step 2 Plates and Step 1 tubes. |
|
| 02 May 2024 |
Global Manufacturing Technology Pty Ltd Paragon Stem Standard Collared Size 7 / Paragon Stem High Offset Size 8 [Part Numbers: GM08001-201-07 / GM08001-202-08; Lot Numbers: 536023 / 536015] |
|
| 02 May 2024 |
Butterfly Network Inc Butterfly iQ/ iQ+/ iQ3 diagnostic ultrasound imaging system [Software version: 2.33.0] |
|
| 02 May 2024 |
Philips Ingenia Evolution systems with software R5.7.1 [Ingenia 1.5T or Ingenia 3.0T system] |
|
| 30 Apr 2024 |
Intersurgical UAB Mapleson F Anaesthetic Breathing Systems |
|
| 30 Apr 2024 |
SonarMed Inc. Recalls Airway Monitors Due to a Software Anomaly Resulting in Failure to Detect a Partial Obstruction in 2.5mm Sensors and Up To 3mm Distal to the Sensor Tip |
|
| 30 Apr 2024 |
Maquet Critical Care AB (Getinge) Sevoflurane vaporizers |
|
| 30 Apr 2024 |
Intervascular SAS (Getinge) Intergard / Hemagard Knitted Collagen Coated Vascular Grafts |
|
| 30 Apr 2024 |
SonarMed Inc. Recalls Airway Acoustic Sensors Due to a Restricted Inner Diameter of Airway Causing Suction Catheter Passage Difficulty |
|
| 29 Apr 2024 |
Evolutis SAS (Sponsored by Evolutis MA Australia Pty Ltd) Stemsys cemented Femoral Stems - coated femoral stem prosthesis modular |
|
| 29 Apr 2024 |
Cylite Pty Ltd Hyperparallel Optical Coherence Tomograph [Product Code: HP-OCT; Serial Numbers: 14329, 15237] |
|
| 29 Apr 2024 |
偉康股份有限公司 Respironics, Inc 呼吸機 [BiPAP A30、BiPAP A40 和 OmniLab Advanced+] |
|
| 29 Apr 2024 |
Draeger Medical GmbH 病人監護儀 [涉及產品型號、規格: Infinity Acute Care System (IACS) Monitoring Solution] |
|
| 27 Apr 2024 |
Biomerieux Inc VITEK 2 - AST Test kits |
|
| 26 Apr 2024 |
InfuTronix, LLC Recalls Nimbus and Nimbus II Infusion Pump Systems for Multiple Device Failures That May Cause Severe Injury and Death |
|
| 26 Apr 2024 |
Draeger, Inc. Recalls Perseus A500 Anesthesia System for Risk of Sudden Unexpected Shutdown When Used on Battery Power |
|
| 26 Apr 2024 |
Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs |
|
| 26 Apr 2024 |
UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: 美國FDA Safety Communication |
|
| 26 Apr 2024 |
Covidien LP Palindrome Precision HSI Chronic Catheter Sport Pack, Palindrome Precision H Chronic Catheter Kit |
|
| 26 Apr 2024 |
生物梅里埃法國股份有限公司 bioMerieux, SA 革蘭陰性細菌藥敏卡片 |
|
| 26 Apr 2024 |
Zimmer Surgical SA (Sponsored by Zimmer Biomet Pty Ltd) X Series Power System Double Trigger Handpiece [Item number: 89-8520-400-00; Multiple item numbers, lot numbers, serial numbers and UDI numbers] |
|
| 26 Apr 2024 |
Thermo Fisher Scientific D-Dimer Calibration Set [Catalog Number: 981871; UDI: (01)16438153000751(17)241130(10)W717A, (01)16438153000751(17)241130(10)W717B; Lot Number: W717A, W717B] |
|
| 26 Apr 2024 |
Philips 5000 Compact Series Ultrasound Systems [Models 5500 and 5300] |
|
| 26 Apr 2024 |
Olympus Soltive Fiber Strippers [Model Number: TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940; Lot number: All] and Soltive Fiber Cleavers [Model Number: TFL-AFC; Lot number: All] |
|
| 26 Apr 2024 |
偉康股份有限公司 Respironics, Inc 呼吸機、無創呼吸機 (BiPAP A30, BiPAP A40, OmniLab Advanced+) |
|
| 26 Apr 2024 |
Quidel Corporation QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests [UDI: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025]; QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests [UDI: 30014613336747/Lot # 162620 and 162748] |
|
| 26 Apr 2024 |
Bolton Surgical Ltd Mosquito Artery Forceps Curved 125mm [Product Code: 11-1512-06] |
|
| 26 Apr 2024 |
Bolton Surgical Ltd Rampley Sponge Forceps 240mm [Product Code: 11-1851-03] |
|
| 26 Apr 2024 |
BD BD neXus V700 Infusion Pump [Product Code (REF): V700-00; UDI-DI: 06926802608784; Manufacturer’s SRN: CN-MF-000005925] |
|
| 26 Apr 2024 |
Deerfield Imaging, Inc. iMRI 3T S [Model or Catalog Number: 116118-000; Lot or Serial Number: 10093-01] |
|
| 26 Apr 2024 |
美敦力導航股份有限公司 Medtronic Navigation, Inc. 顱腦外科手術定位設備 Cranial surgical navigation and positioning system [涉及產品型號、規格及批次: 29631, 28635; 識別信息(如批號): 0112, 0113, 0114, 0117, 0150, 0151, 0152, 0155, 0158, 0159, 0161, 0166, 0168, 0177, 0178, 0179, 0180, 0181, 0243, 0244, 0254, 0255, 0164, 0165, 200707, 200710] |
|
| 26 Apr 2024 |
美敦力公司 Medtronic Inc. 植入式可充電脊髓神經刺激器 [涉及產品型號、規格及批次: 97715; 識別信息(如批號): NME825619H] |
|
| 26 Apr 2024 |
Update: Potential Risk of Exposure to Toxic Compounds When Using Hemodialysis and Peritoneal Dialysis Systems – Letter to Health Care Providers |
|
| 26 Apr 2024 |
Fresenius Medical Care Recalls Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapter for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA |
|
| 26 Apr 2024 |
3M Company 3M Durapore Surgical Tape [Catalog Number: 1538-118] |
|
| 26 Apr 2024 |
ROUTE 92 MEDICAL INC Full Length 070 Access System, Full Length 070 Reperfusion System, 070 Access System, Tenzing 7 Delivery Catheter, 070 Reperfusion System |
|
| 26 Apr 2024 |
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. BD neXus V700 Infusion Pump and BD neXus S700 Syringe Pump [Catalog Number (REF): V700-00, S700-00] |
|
| 26 Apr 2024 |
In2Bones SAS NEOFIT screw - locking diam 3.0mm – Lg12mm [Part number: V30 ST112, V30 ST114] |
|
| 26 Apr 2024 |
Bolton Surgical Ltd Mcindoe Dissecting Forceps [Model/Catalogue/part number: 11-1663-01] |
|
| 25 Apr 2024 |
DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist |
|
| 25 Apr 2024 |
Fisher And Paykel Healthcare Ltd. Airvo 2 and MyAirvo 2 Humidifier |
|
| 25 Apr 2024 |
EBI, LLC Biomet SpinalPak Non-invasive Spine Fusion Stimulator System [Part Number: 1067716; UDI-DI: 00812301020218], Biomet OrthoPak Non-invasive Bone Growth Stimulator System [Part Number: 1067718; UD-DI: 00812301020232], 20" Lead Wires, Replacement [Part Number: 1067724-2; UDI-DI: 00812301020300], 48" Lead Wires, Replacement [Part Number: 1067724-4; UDI-DI: 00812301020324] |
|
| 25 Apr 2024 |
Philips Incisive CT/CT 3500/CT 5300 System |
|
| 25 Apr 2024 |
XENEX Disinfection Services Inc. LightStrike Blackout Curtains [Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024] |
|
| 25 Apr 2024 |
SEASPINE ORTHOPEDICS CORPORATION Mariner RDX MIS Polyaxial Head |
|
| 25 Apr 2024 |
SEASPINE ORTHOPEDICS CORPORATION Mariner RDX Polyaxial Head, Mariner RDX Extended Polyaxial Head, Mariner RDX Deformity Head, Mariner RDX Extended Deformity Head, Mariner RDX Trauma Head, Mariner RDX Extended Trauma Head |
|
| 25 Apr 2024 |
Cardinal Health Curity Flexible Adhesive Bandage [Model or catalog number: 44102; Lot or serial number: A14722] |
|
| 24 Apr 2024 |
Masimo Corporation Rad-G Device and Rad-G Device with temp |
|
| 24 Apr 2024 |
Crospon Ltd (Sponsored by Medtronic Australasia Pty Ltd) Esoflip Dilation Catheter 30mm |
|
| 23 Apr 2024 |
Medtronic Inc Cobalt XT HF Cardiac Resynchronization Therapy Defibrillator Evera XT DR Defibrillator |
|
| 22 Apr 2024 |
Beckman Coulter Inc DxI 9000 Access Immunoassay Analyser [Ref: C11137; Software: SW 1.13 and higher] |
|
| 22 Apr 2024 |
Parker Laboratories, Inc. Redux Electrolyte Crème [Product No. 66-04] |
|
| 22 Apr 2024 |
SonarMed Inc AW-M0001 SONARMED MONITOR [Model No.: AW-M0001] |
|
| 22 Apr 2024 |
Siemens Medical Solutions USA, Inc. ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System, ACUSON Redwood 1.0 Diagnostic Ultrasound System, ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select |
|
| 22 Apr 2024 |
Stihler Electronic GmbH (Sponsored by SponsorFairmont Medical Products Pty Ltd) SECOV150 / SECOV105 |
|
| 22 Apr 2024 |
Beckman Coulter Inc DxI 9000 Access Immunoassay Analyzer [REF: C11137; Software: SW 16.2 and prior] |
|
| 20 Apr 2024 |
Draeger Medical, Inc. Dr¿ger Perseus A500 Anesthesia Workstation [Material No. MX06000] |
|
| 20 Apr 2024 |
Covidien llc (Sponsored by Medtronic Australasia Pty Ltd), Medtronic Australasia Pty Ltd Tri-Staple 2.0 Black Reinforced Intelligent Reload [Model number: SIGTRSB60AXT; Lot number: N3G1372Y; |
|
| 20 Apr 2024 |
Medartis AG (Sponsored by Medartis Australia & New Zealand Pty Ltd) Medartis APTUS TriLock Screw [Part name: 2.8 TriLock Screw 22mm, HD7, 1/Pkg; Part number: A-5850.22/1; Lot number: 24377397] |
|
| 20 Apr 2024 |
SonarMed Inc 1) AW-S025 NEO SONARMED SENSOR 2.5MM [Product Number/CFN: AW-S025; UDI-DI: 10851334007183; Serial Numbers: A20221012, A20221018, A20221025, A20221107, A20221109, A20221202, A20221206, A20221207, A20221208, A20221209, A20230105, A20230109, A20230123, A20230124, A20230125, A20230126, A20230213, A20230224, A20230228, A20230301, A20230302, A20230303, A20230320, A20230324, A20230411, A20230724, A20230725], 2) AW-S030 NEO SONARMED SENSOR 3.0MM [Product Number/CFN: AW-2030; UDI-DI: 10851334007190; Serial Numbers: A20221012, A20221017, A20221024, A20221103, A20221115, A20221116, A20221117, A20221118, A20221130, A20221206, A20221222, A20221228, A20221229, A20230104, A20230111, A20230116, A20230117, A20230118, A20230208, A20230209, A20230313, A20230314, A20230315, A20230316, A20230317, A20230405], 3) AW-S035 NEO SONARMED SENSOR 3.5MM [Product Number/CFN: AW-S035; UDI-DI: 10851334007206; Serial Numbers: A20221012, A20221019, A20221026, A20221109, A20221110, A20221111, A20221114, A20221212, A20221213, A20221214, A20221215, A20221216, A20230110, A20230111, A20230112, A20230113, A20230116, A20230130, A20230131, A20230202, A20230206, A20230306, A20230307] |
|
| 20 Apr 2024 |
Raye's Inc. SW Bari Lift & Transfer [Model Number: 38060000; UDI/DI: 00845699001040; All serial numbers] |
|
| 19 Apr 2024 |
Stryker Neurovascular Trevo Retrievers/Microcatheters, FlowGate2, Distal Access Catheter (DAC) and Synchro |
|
| 19 Apr 2024 |
"NeoMed Inc (Sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia) NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) [Multiple product codes and syringe sizes; All lot numbers] " |
|
| 19 Apr 2024 |
Conformis, Inc. Identity Imprint PS Tibial Tray Size 4 [Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number: 540287] |
|
| 19 Apr 2024 |
Actim OY Actim PROM dipstik [REF: 30831ETUS] |
|
| 19 Apr 2024 |
Lemaitre Vascular, Inc. Syntel Silicone Thrombectomy Catheter [Model or Catalogue Number: A4558 A5568 A4548 A4554; Lot or Serial Number: SST1064 SST1067 SST1063 SST1066 SST1031] |
|
| 19 Apr 2024 |
Philips Respironics, Inc. Trilogy Evo, Trilogy Evo O2, and Trilogy EV300 devices, Aeris EVO, Garbin EVO, LifeVentEVO2 and Trilogy Evo Universal Ventilator |
|
| 18 Apr 2024 |
柯惠有限責任公司Covidien llc 球囊穿刺器與充氣球囊 |
|
| 18 Apr 2024 |
望嵐達公司 One Lambda, Inc 人類白細胞抗原-DNA分型試劑盒(序列特異性寡核苷酸探針法) |
|
| 18 Apr 2024 |
Respironics Inc. Omnilab Advanced Domestic and Omnilab Advanced Domestic Core |
|
| 18 Apr 2024 |
Elekta Instrument AB Disposable Biopsy Needle Kit for Leksell Stereotactic System [UDI/DI: 07340048308007; Lot Number: 911761, UDI/DI 07340048308014, Lot Number: 912465, UDI/DI 07340048300346; Lot Number: 911933] |
|
| 18 Apr 2024 |
Artivion, Inc CryoValve SG Cryopreserved Pulmonary Human Heart Valve [Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447] |
|
| 18 Apr 2024 |
Unomedical A/S Neria Soft Infusion Set [Product Code: 507302; UDI/DI 05705244001558; Lot Numbers: 5277396, 5371146] |
|
| 18 Apr 2024 |
Smiths Medical ASD Inc. 1) Smiths Medical Medfusion Model 3500 Syringe pumps; 2) Smiths Medical Medfusion Model 4000 Syringe pump; 3) Smiths Medical Model 3010 Syringe pumps; 4) Smiths Medical Medfusion Guide Barrel Clamp |
|
| 18 Apr 2024 |
Leica Biosystems Nussloch GmbH 1) HistoCore Pegasus [Serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782]; 2) HistoCore Pegasus Plus [Serial numbers: P0061 - P0080, P0082 - P0116, P0119 - P0156, P0158- P0164, P0166 - P0201, P0203 - P0232, P0234] |
|
| 18 Apr 2024 |
Zimmer Inc. Nexgen CR-Flex Femoral Component, Size E And Size E Minus (E-) |
|
| 18 Apr 2024 |
美國捷邁公司 Zimmer Inc 全膝關節假體系統 Knee Joint Prostheses |
|
| 18 Apr 2024 |
"Boston Scientific Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) [Material Number: M365DB12160, M365DB12320; GTIN: 8714729985044, 8714729985051; Serial Number Range: 100209 - 753347; 100104 - 753200; Expiration Date Range: 09-OCT-2020 through 26-MAR-2026]" |
|
| 18 Apr 2024 |
Boston Scientific Recalls Obsidio Conformable Embolic for Increased Bowel Ischemia Risk When Used for Lower GI Bleeding |
|
| 18 Apr 2024 |
Ortho-Clinical Diagnostics 奧森多臨床診斷(英國)有限責任公司 游離三碘甲狀腺原氨酸測定試劑包(化學發光法) [100測試/包裝];游離三碘甲狀腺原氨酸校準品 [3套/包裝] [識別信息 (如批號): 批次: 3042、3052、3061、3080、 3090.、 3100、3110、3126] |
|
| 18 Apr 2024 |
邁柯唯心肺醫療有限責任公司 Maquet Cardiopulmonary GmbH 離心泵 Rotaflow |
|
| 18 Apr 2024 |
史賽克神經介入 Stryker Neurovascular 遠端通路導管 Distal Access Catheter [涉及產品型號、規格及批次: 90721; 識別信息 (如批號): 0000486382] |
|
| 18 Apr 2024 |
雷度米特醫療設備有限公司 Radiometer Medical ApS 血氣、血氧、電解質和代謝物分析儀 ABL90 FLEX Analyzer [識別信息 (如批號): R0272N0006; R0272N0007; R0292N0010O; RI032N0061; RI 055N0056; Rl296N00l2; R1296N0022] |
|
| 17 Apr 2024 |
GE Healthcare Iits Usa Corp Also Doing Business As GE Healthcare Universal Viewer |
|
| 17 Apr 2024 |
PharmaResearch Co Ltd (Sponsored by K Bridge Medical Pty Ltd) Rejuran Dermal tissue reconstructive material animal-derived |
|
| 17 Apr 2024 |
Randox Laboratories Ltd Human Assayed Multi-Sera Level 3 |
|
| 16 Apr 2024 |
Olympus Medical Systems Corporation High Flow Insufflation Unit UHI-4 |
|
| 16 Apr 2024 |
Smiths Medical Portex Blue Line Siliconised PVC Tracheotomy Tubes |
|
| 16 Apr 2024 |
Medline Endocavity Probe Covers |
|
| 16 Apr 2024 |
Jenx Limited Supine 2 and Multistander 2 |
|
| 15 Apr 2024 |
Cook Incorporated 1) Chiba Biopsy Needle; 2) Trocar Needle; 3) Yueh Centesis Disposable Catheter Needle; 4) Peel-Away Introducer ; 5) Entuit Secure Adjustable Gastrointestinal Suture Anchor Set; 6) Dilator; 7) Dilator With AQ Hydrophilic Coating; 8) Dilator - Coons Taper |
|
| 15 Apr 2024 |
Nipro Corporation Surdial X [Serial number: 22DS10671] |
|
| 15 Apr 2024 |
Dentalife Australia Pty Ltd Endosure Hypochlor 1% |
|
| 15 Apr 2024 |
Intuitive Surgical, Inc. Patient Cart [Part: 380601] |
|
| 15 Apr 2024 |
SURGICAL SPECIALTIES POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA |
|
| 15 Apr 2024 |
Outset Medical, Inc. Tablo Hemodialysis System |
|
| 15 Apr 2024 |
Ethicon, Inc. STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM |
|
| 15 Apr 2024 |
Baxter Healthcare Corporation Surgical Tools and Cardiovascular Specialty marketing brochures |
|
| 15 Apr 2024 |
"Boston Scientific Corporation EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2); EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2); EndoVive 20Fr Push Safety PEG Kit (Box 2); EndoVive 20Fr Push Standard PEG Kit (Box 2) EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)" |
|
| 12 Apr 2024 |
Philips Ultrasound LLC 5000 Compact Series Ultrasound Systems [Model numbers: 5500, 5300] |
|
| 12 Apr 2024 |
ResMed Corp (Sponsored by Resmed Pty Ltd) Airview 4.44 [Product code: 22240, 22241, 22242] |
|
| 12 Apr 2024 |
Baxter Healthcare Corporation Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, Hillrom Welch Allyn Spot Vision Screener VS100, Power Cords |
|
| 12 Apr 2024 |
Medline Industries, Lp Blood Pressure Unit [Model or catalogue number: MDS4001PLUS, MDS4001, MDS4001LA] |
|
| 12 Apr 2024 |
Agilent Technologies Singapore (International) Pte Ltd. 1) Coverstainer, Dako Coverstainer Cpo [Model or catalogue number: CS100; Lot or serial number: CS10030,CS10040,CS10026]; 2) Dako Coverstainer, Dako Coverstainer Cpo [Model or catalogue number: CS100; Lot or serial number: CS10030,CS10040,CS10026] |
|
| 11 Apr 2024 |
Swemac Innovation AB (Sponsored by Medical & Optical Instruments Australia Pty Ltd) Motec Wrist Arthrodesis System [Angled Double Taper 15° Short (Part number: 41-3101S); Angled Double Taper 15° Medium (Part number: 41-3102S); Angled Double Taper 15° Long (Part number: 41-3103S); Angled Double Taper 15° Extra long (Part number: 41-31014S); Lot numbers: All] |
|
| 11 Apr 2024 |
Airway Surgical Appliances Ltd. 7392 PCP Folding Bathtub Transfer Bench [Model or Catalogue Number: 73922401001, 73922401500] |
|
| 11 Apr 2024 |
"Cardinal Health Jackson-Pratt 3-Spring Reservoir Kits [Jackson-Prat Universal Connector Pvc Tubing Anti Reflux Transparent Y (Model or Catalogue Number: SU130-4601; Lot or Serial Number: 210751D6); Jackson-Pratt 3-Spring Reservoir Kits (Model or Catalogue Number: SU130-403D, SU130-401D, SU130-402D); Jackson-Pratt 3-Spring Reservoir With Silicone Adapters, 400ml (Model or Catalogue Number: SU130-475; Lot or Serial Number: 231251D5]" |
|
| 11 Apr 2024 |
Getinge Leg holder [Item number: 100380A0] |
|
| 11 Apr 2024 |
UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: 美國FDA Safety Communication |
|
| 11 Apr 2024 |
St Jude Medical Cardiac Rhythm Management Division (Sponsored by Abbott Medical Australia Pty Ltd) myMerlinPulse Patient Application [Model number: APP1004 (Android) and APP1005 (iOS)] |
|
| 11 Apr 2024 |
Abbott Medical (Sponsored by Abbott Medical Australia Pty Ltd) myMerlin Mobile Application (iOS) version 1.0.1003 [Model number: APP1001] |
|
| 11 Apr 2024 |
Abbott Medical (Sponsored by Abbott Medical Australia Pty Ltd) myMerlin Application software versions v.1.0.6000, v.1.0.6001, or v.1.0.6002 [Model: APP1000 (Android), APP1001 (iOS)] |
|
| 11 Apr 2024 |
Synovo Production ACETABULAR FIXATION CUP, ACETABULAR BEARING and Femoral Resurfacing Cup |
|
| 11 Apr 2024 |
Abbott Medical Merlin.net Web Application and Database [Model: APP1000 (Android), APP1001 (iOS)] |
|
| 11 Apr 2024 |
Philips North America PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989 |
|
| 11 Apr 2024 |
Stryker Communications Chromophare Surgical Light System [REF CH00000001] |
|
| 11 Apr 2024 |
ConvaTec, Inc ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in |
|
| 10 Apr 2024 |
Fisher & Paykel Healthcare Ltd (Sponsored by Fisher & Paykel Healthcare Pty Ltd) Airvo 2 devices [Airvo 2 and myAirvo 2] |
|
| 10 Apr 2024 |
Philips Ultrasound Llc Ultrasound System 5500, Ultrasound System 5500CV |
|
| 10 Apr 2024 |
Cook Ireland Limited EchoTip Ultra High Definition Ultrasound Access Needle, EchoTip Ultra Endoscopic Ultrasound Needle |
|
| 10 Apr 2024 |
Ortho-Clinical Diagnostics Inc. Ortho Vision Analyzer and Ortho Vision Max Analyzer |
|
| 10 Apr 2024 |
Bio-Rad Medical Diagnostics Gmbh DiaClon ABO/D+ Reverse-Group |
|
| 10 Apr 2024 |
Swemac Innovation AB, Sweden Motec Wrist Radius Hemi Prosthesis |
|
| 10 Apr 2024 |
Micromed S.p.A. a socio unico (Natus) BRAIN QUICK SOFTWARE version 3.05.00 |
|
| 10 Apr 2024 |
KARL STORZ SE & Co. KG LASER Application Instrument, 23 cm and LEUNIG-GREVERS LASER Application |
|
| 10 Apr 2024 |
Green Power Trading UK Limited Lithium-Ion Battery |
|
| 09 Apr 2024 |
Medline Industries, LP Issues a Nationwide Recall of Convenience Kits Containing Nurse Assist 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP |
|
| 09 Apr 2024 |
Bolton Surgical Ltd (Device Technologies Australia Pty Ltd) Weislander Self Retaining Retractor 14cm BL |
|
| 09 Apr 2024 |
RaySearch Laboratories AB (publ) (Emergo Asia Pacific Pty Ltd T/a Emergo Australia) RayStation RayPlan 7 through 2024A including some service packs |
|
| 09 Apr 2024 |
Merit Medical Systems Inc. Prelude Roadster Guide Sheath |
|
| 09 Apr 2024 |
Stryker EXETER 2.5 IM PLUG |
|
| 08 Apr 2024 |
Microbiologics Inc KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b [REF 0209P and REF 0209K] |
|
| 08 Apr 2024 |
Human Care Hc Sweden Ab Altair 330 lbs w/o Hanger Bar [REF: 55200H-NA, 55220H-NA] and Roomer S 220 kg w/o Hanger Bar [REF: 55300H-NA] |
|
| 08 Apr 2024 |
AusDiagnostics Pty Ltd Respiratory Pathogens (16-well) Step 1 Tubes [Catalogue numbers: 20620S, 20613S; Batch numbers: S3108211, S3106493] |
|
| 08 Apr 2024 |
Medline Industries, Lp 5 Inch Curved Mosquito Forceps, Adson Forceps, Standard, 4.75 In [Model or catalog number: DYNJ04052; Lot or serial number: 2023021590, 2023111390], Sterile Scissors [Model or catalog number: DYND04000, DYND04006; Lot or serial number: Multiple] |
|
| 08 Apr 2024 |
MEDLINE INDUSTRIES, LP - Northfield Bed Assist Bars - Medline |
|
| 08 Apr 2024 |
Vyaire Medical, Inc. Airlife Adult Manual Resuscitator |
|
| 08 Apr 2024 |
Philips Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system |
|
| 05 Apr 2024 |
Medos International Sàrl Recalls Cerenovus CEREBASE DA Guide Sheath due to Cracking of the Distal Catheter Shaft |
|
| 05 Apr 2024 |
SleepNet Corporation Mojo, Mojo 2, iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask |
|
| 05 Apr 2024 |
Teleflex and Arrow International Recall ARROW QuickFlash Radial Artery and Radial Artery/Arterial Line Catheterization Kits for Increased Resistance That May Lead to Vessel Injuries, Narrowing, or Blockage |
|
| 05 Apr 2024 |
Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation |
|
| 05 Apr 2024 |
Product Defect Alert: A40/30 BiPAP Series |
|
| 05 Apr 2024 |
Product Defect Correction: Fanttest COVID-19 / Influenza A&B Antigen Test Kit - Potential for control line variability |
|
| 05 Apr 2024 |
Abbott GmbH ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35; Alinity i Anti-HCV Reagent Kit, List Number 08P0521 |
|
| 05 Apr 2024 |
O&M HALYARD, INC. HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) [Model No. 69110; UDI-DI: 20680651691105; Lot No. CG22292XXX] |
|
| 05 Apr 2024 |
Karl Storz Endoscopy Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only [UDI: 04048551050255/ All Lots]; Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE [UDI: 04048551259788/ All Lots]; Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only [UDI: 04048551193587/ All Lots] |
|
| 05 Apr 2024 |
Navinetics Inc NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 [UDI/DI 10850023620276, Lot Number 331401724] |
|
| 05 Apr 2024 |
Technicality Inc. Trumpet, Needle Guide, Cat# TMS-200 [Lot Numbers: 22190 & 22497] |
|
| 05 Apr 2024 |
MEDLINE INDUSTRIES, LP - Northfield Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS [a) MDS4001, UDI/DI 100888277361228, Lot Numbers: 230280001, 230380001, 230680001, 230780001, 230880001; b) MDS4001LA, UDI/DI 100884389106955, Lot Numbers: 230480003, 230780003, 231180003; c) MDS4001PLUS, UDI/DI 100888277362089, Lot Numbers: 230280004, 230480004, 230780004, 231080004] |
|
| 05 Apr 2024 |
Zimmer Biomet NexGen CR-Flex Femoral Component, Porous, Size E, Right [Item number: 00-5952-015-02; Lot numbers: 64138317, 64275541] |
|
| 05 Apr 2024 |
Medtronic HeartWare Ventricular Assist Device (HVAD) System |
|
| 05 Apr 2024 |
Heartsine Technologies, Ltd. Heartsine Samaritan PAD 350P [Model or catalog number: SAM 350P; Lot or serial number: Mulitple] , Heartsine Samaritan PAD 360P [Model or catalog number: SAM 360P; Lot or serial number: Mulitple], Heartsine Samaritan PAD 500P [Model or catalog number: SAM 500P; Lot or serial number: Mulitple] |
|
| 05 Apr 2024 |
Ningbo Matrixendo Medical Instrument Co Ltd (Sponsored by CK Surgitech Pty Ltd) Bedside clean kit enzymatic imbibed sponge and container [Product code: CK-BCK; Lot number: 20231010] |
|
| 05 Apr 2024 |
Southern Implants (Pty) Ltd Temporary Healing Abutments |
|
| 05 Apr 2024 |
"Siemens Healthineers AG Artis system [Artis Q floor; UDI-DI: 4056869009971], Artis Q ceiling [UDI-DI:4056869009988], Artis Q biplane [UDI-DI: 4056869009995], Artis Q zeego [UDI-DI: 4056869010007], Artis Q.zen floor [UDI-DI: 4056869010014], Artis Q.zen ceiling [UDI-DI: 4056869010021], Artis Q.zen biplane [UDI-DI: 4056869010038], Artis Q zeego [UDI-DI: 4056869012711], Artis zee floor [UDI-DI: 4056869010045], Artis zee ceiling [UDI-DI: 4056869010052], Artis zee multi-purpose [UDI-DI:4056869010076], Artis zee biplane [UDI-DI: 4056869010069], Artis zee floor MN [UDI-DI: 4056869010090], Artis zee biplane MN [UDI-DI: 4056869010106], Artis zeego [UDI-DI: 4056869010083b], Artis zee III floor [UDI-DI: 4056869012643], Artis zee III ceiling [UDI-DI: 4056869012650], Artis zee III multi-purpose [UDI-DI: 4056869012667], Artis zee III biplane [UDI-DI: 4056869012674] Artis zeego III [UDI-DI FU: 4056869012681], Artis zee III floor MN 4056869012698, Artis zee III biplane MN " |
|
| 05 Apr 2024 |
Provita medical gmbh & co. kg Straight IV-Pole [Article number: 353683; UDI-DI: 4260661457742], Angled IV-Pole [Article number: 353692; UDI-DI: 4260661457735] in combination with Medstrom Solo® bed |
|
| 05 Apr 2024 |
Össur Rheo Knee [Catalog number: RKN130002, RKN130003, RKN130005, RKN13006A, RKN120008], Rheo Knee XC [Catalog number: RKNXC0002, RKNXC0003, RKNXC0005, RKNXC006A] |
|
| 05 Apr 2024 |
NRT X-Ray A/S Intelli-C [Ref: 03500000, 03500010] and Celex X-ray devices [Ref: 03200000, 03200010] |
|
| 05 Apr 2024 |
Mathys Ltd Bettlach Affinis Inverse Drill-bit 2.5, Gen2 [Item number: 61.34.0184; Batch number: All batch numbers lower than 2277885], Affinis Inverse Drill-bit 3.2, Gen2 [Item number: 61.34.0185; Batch number: All batch numbers lower than 2277886] |
|
| 05 Apr 2024 |
Maquet Cardiopulmonary GmbH CARDIOHELP-I [UDI-DI: 04037691658384; Item number: 701048012; Serial number: 90410081, 90410082 , 90410112 , 90410137] |
|
| 05 Apr 2024 |
FH ORTHO group EASYMOVE CURVED BLADE LINVATEC HALL [Ref: 270666; Lot number: All Lots], EASYMOVE CURVED BLADE SYNTHES [Ref: 270667; Lot number: All Lots], EASYMOVE CURVED BLADE STRYKER [Ref: 270668; Lot number: All Lots] |
|
| 05 Apr 2024 |
East Midlands Pharma Limited (EM Pharma) Calendula and Hamamelis Spray [Batch number: EM223723, EM233777, EM233782, EM233783, EM233788, EM233821, EM233824, EM233851, EM233920, EM233915, EM233926, EM233941, EM233961] |
|
| 05 Apr 2024 |
Honeywell Safety Products USA Eyesaline Emergency Eyewash ; Eyesaline Solution [Lot number: 70502221, 70503221, 70504221, 70505221, 70506221, 70509221, 70510221, 70511221, 70512221, 70613221, 70614221, 70615221, 70616221, 70617221, 70703221, 70705221, 70706221, 70707221, 70708221, 70711221, 71010221, 71011221, 71012221, 70418231, 70420231, 70421231, 70424231, 70425231, 70426231, 70427231, 70428231, 70501231, 70508231, 70509231, 70511231, 70512231, 70522231, 70525231, 70526231, 70601231, 70605231, 70608231, 70609231, 70613231, 70614231, 70615231, 70619231, 70620231, 70621231] |
|
| 05 Apr 2024 |
Medline Industries, Lp AHS Paracervical/Pudendal Kit [Model or catalogue number: DYNJRA2210; Lot or serial number: 23JBX245, 23LBN930], Paracervical/Pudendal Blk Kit [Model or catalogue number: DYNJRA9046; Lot or serial number: 23JBX369, 23LBL612, 23LBV326, 23JBX367, 23JBX370, 23LBV325, 23LBA896, 23JBX368, 23LBH751] |
|
| 05 Apr 2024 |
Biomerieux, Inc. Vitek 2 System - Susceptibility Test Cards [Model or catalogue number: 423340, 423341; Lot or serial number: 1402761504, 1412754504] |
|
| 05 Apr 2024 |
Respironics Inc. Omnilab Advanced [Model or catalogue number: 1044278; Lot or serial number: All lots.] |
|
| 05 Apr 2024 |
費雪派克醫療保健有限公司 呼吸濕化治療儀 [涉及產品型號、規格: PT101AZ, PT100AZ] |
|
| 05 Apr 2024 |
辛迪思有限公司 Synthes GmbH 椎間融合器 Cages [涉及產品型號、規格: 870.925S, 870.923S; 識別信息 / 批號: 7L09053, 6L82339] |
|
| 03 Apr 2024 |
Medtronic HeartWare Ventricular Assist Device (HVAD) System: Update regarding HVAD power source management and Autologs feature |
|
| 03 Apr 2024 |
士卓曼(中國)投資有限公司 牙科種植用延長器 |
|
| 03 Apr 2024 |
邦美骨科公司 Biomet Orthopedics 膝關節組件 |
|
| 03 Apr 2024 |
GE MEDICAL SYSTEMS SCS 通用電氣醫療系統兩合公司 醫用血管造影X射線機 |
|
| 03 Apr 2024 |
力康華耀生物科技(上海)有限公司 嬰兒培養箱 |
|
| 03 Apr 2024 |
高級滅菌產品公司 過氧化氫低溫等離子滅菌器Sterilizer; 過氧化氫低溫等離子滅菌系統Sterilizer |
|
| 03 Apr 2024 |
西恩尤斯股份有限公司 Xenios AG 體外心肺支持輔助設備 |
|
| 03 Apr 2024 |
Respironics Inc (Sponsored by Philips Electronics Australia Ltd) BiPAP Devices [BiPAP A30, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro] |
|
| 02 Apr 2024 |
Philips Medical Systems DMC GmbH (Sponsored by Philips Electronics Australia Ltd) Mobile Diagnostic wDR 2.x Systems |
|
| 02 Apr 2024 |
CooperSurgical Inc (Sponosred by Endotherapeutics Pty Ltd) Endosee Advance Cannula Device |
|
| 02 Apr 2024 |
Abbott Molecular Inc (Sponsored by Abbott Australasia Pty Ltd Molecular Division) Alinity m System |
|
| 02 Apr 2024 |
Vivo Surgical Private Limited (Sponsored by E & L May Pty Ltd) KLARO In Vivo Surgical Lighting |
|
| 02 Apr 2024 |
EMS Electro Medical Systems SA (Sponsored by EMS Oceania Pty Ltd) AIRFLOW PROPHYLAXIS MASTER or AIRFLOW One |
|
| 02 Apr 2024 |
Smith & Nephew Medical Ltd. Renasys Edge Canister With Solidifier(300,800ml) |
|
| 02 Apr 2024 |
柯惠有限責任公司Covidien llc 一次性使用腔鏡下預置芯片切割吻合器釘匣 |
|
| 02 Apr 2024 |
Emergency Products & Research O.T.D - Optimum Traction Device - Street Orange |
|
| 02 Apr 2024 |
Baxter Healthcare Corporation Hill-Rom PRO+ 36" MRS Surface |
|
| 02 Apr 2024 |
Medical Action Industries, Inc. IV Start Kit, containing 1 Saline Syringe 5ml |
|
| 02 Apr 2024 |
Masimo Corporation Rad-G Pulse Oximeter, Rad-G Pulse Oximeter With Temperature |
|
| 02 Apr 2024 |
X-NAV Technologies, LLC A) X-Guide Handpiece Adaptor Sleeve 1; B) X-Guide Handpiece Adaptor Sleeve 3 |
|
| 02 Apr 2024 |
Boston Scientific Corporation OptiCross Coronary Imaging Catheter |
|
| 02 Apr 2024 |
MEDLINE INDUSTRIES, LP - Northfield Centurion kits and other medical devices |
|
| 02 Apr 2024 |
DeRoyal Industries Inc GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART |
|
| 02 Apr 2024 |
Boston Scientific Corporation Obsidio Conformable Embolic |
|
| 02 Apr 2024 |
Life Technologies Corporation Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD |
|
| 02 Apr 2024 |
Puritan Medical Products Company, LLC HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H |
|
| 02 Apr 2024 |
Terumo Cardiovascular Systems Corporation Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A |
|
| 02 Apr 2024 |
Bolton Medical Inc RELAY PRO Thoracic Stent-Graft System |
|
| 02 Apr 2024 |
Philips Medical Systems Nederland B.V. Ingenia Ambition X |
|
| 28 Mar 2024 |
"Fresenius Medical Care Holdings, Inc. 1) stay-safe /Safe Lock Catheter Ext. 12 in; 2) stay-safe /Luer Lock Adapter 4 in; 3) stay-safe /Luer Lock Catheter Ext. 12 in; 4) stay-safe /Luer Lock Catheter Ext. 18 in; 5) stay-safe /Luer Catheter Ext. 6 in" |
|
| 28 Mar 2024 |
Miltenyi Biotec CliniMACS Prodigy TS 310 [UDI-DI: 04049934003226], CliniMACS Prodigy Instrument [UDI: 04049934135415], CliniMACS Prodigy LP-TCRα/β-19 System Application |
|
| 28 Mar 2024 |
MicroPort CRM XFine leads [Models: XFine TX25D, XFine TX26D, XFine JX24D; XFine JX25D] connected to MicroPort CRM ALIZEA or BOREA pacemakers |
|
| 28 Mar 2024 |
Medtronic Palindrome Precision H Chronic Catheter Kit – 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet |
|
| 28 Mar 2024 |
Medtronic Hugo robotic-assisted surgery (RAS) system surgeon console |
|
| 28 Mar 2024 |
EKF-diagnostic GmbH Quo-Lab A1c Test Kit |
|
| 28 Mar 2024 |
Boston Scientific EXPO 5F Angiographic Catheters |
|
| 28 Mar 2024 |
Beckman Coulter DxI 9000 Access Immunoassay Analyzer |
|
| 28 Mar 2024 |
Ortho-Clinical Diagnostics VITROS Performance Verifier I [Product Code: 8067324; GTIN: 10758750004317; Lot No.: Q1174], VITROS Performance Verifier II |
|
| 28 Mar 2024 |
HMC Premedical SPA ENFit Double Lumen Replogle Tube |
|
| 28 Mar 2024 |
Philips Medical Systems DMC GmbH Mobile Diagnostic wDR 2.x Systems |
|
| 28 Mar 2024 |
Stryker Trident II Hemispherical and PSL Shells |
|
| 28 Mar 2024 |
Philips Magnetic Resonance (MR) systems |
|
| 28 Mar 2024 |
Yourgene Health UK Limited IONA Nx cfDNA Library Preparation Dx Kit |
|
| 28 Mar 2024 |
Swemac Innovation AB Motec Wrist Arthrodesis System |
|
| 28 Mar 2024 |
Ossenberg GmbH Forearm Crutches 220 and 230 with interchangeable handles |
|
| 28 Mar 2024 |
Endotherapeutics Pty Ltd Endosee Advance Cannula Device |
|
| 28 Mar 2024 |
Abbott Australasia Pty Ltd Molecular Division Alinity m System |
|
| 27 Mar 2024 |
Olympus Australia Pty Ltd POWERSEAL Sealer and Divider |
|
| 27 Mar 2024 |
Gambro Lundia AB AK 98, AK 98 (SW 2), AK 98 (SW 3) |
|
| 27 Mar 2024 |
Alcon Laboratories Incorporated (Sponsored by Alcon Laboratories Australia Pty Ltd) Alcon Custom Pak containing Oasis Medical 27G Chang Hydrodissection Cannulas |
|
| 27 Mar 2024 |
美敦力公司 Medtronic Inc. 體外引流裝置 External Drainage and Monitoring System |
|
| 26 Mar 2024 |
Philips Medical Systems CareEvent & Patient Information Center iX (PlC iX) |
|
| 26 Mar 2024 |
Advanced Instruments, LLC OsmoPRO MAX Automated Osmometer |
|
| 26 Mar 2024 |
Cipher Surgical OpClear Disposable Procedure Kit |
|
| 26 Mar 2024 |
Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used |
|
| 26 Mar 2024 |
Smiths Medical ParaPAC plus Model 300 and Model 310 Ventilator |
|
| 26 Mar 2024 |
Medline Industries Recalls Certain Kits and Trays Containing Sterile Water Based Products Under Recall by Nurse Assist |
|
| 26 Mar 2024 |
箭牌國際公司 Arrow International LLC 動脈穿刺導管組 |
|
| 25 Mar 2024 |
Covidien Situate Laparotomy Sponge, RF and X-ray Detectable |
|
| 25 Mar 2024 |
ConvaTec, Inc Convatec EsteemBody Soft Convex |
|
| 25 Mar 2024 |
Alcon Research, LLC SYRINGE,BULB, 2OZ/60CC,GREEN, Part: 300055070 |
|
| 25 Mar 2024 |
Olympus Corporation of the Americas InstaClear Lens Cleaner |
|
| 25 Mar 2024 |
Olympus Medical Systems Corp. Medical Single Use Electrosurgical Knives |
|
| 25 Mar 2024 |
ARROW INTERNATIONAL Inc. ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter) |
|
| 25 Mar 2024 |
Angiodynamics, Inc. MINI STICK MAX |
|
| 25 Mar 2024 |
Spineart SA (Sponsored by Spineart Australia Pty Ltd) PERLA TL 25D SCREW device |
|
| 25 Mar 2024 |
LivaNova Australia Pty Ltd Custom Tubing Pack |
|
| 25 Mar 2024 |
Depuy Ireland Uc ATTUNE AFFIXIUM Knee System Tibial Base |
|
| 25 Mar 2024 |
Fresenius Medical Care AG & Co. KGaA Fresenius Medical Care Haemodialysis Machines Series 4008/5008/6008 |
|
| 25 Mar 2024 |
Landauer microStar Reader |
|
| 25 Mar 2024 |
深圳泰康醫療設備有限公司 臂式電子血壓計 |
|
| 25 Mar 2024 |
Philips Medical Systems Nederland B.V. Magnetic Resonance (MR) Systems |
|
| 22 Mar 2024 |
Abiomed Inc. Impella 5.0 [Model or catalogue number: 005064; All Lots], Impella 5.5 with Smart Assist [Model or catalogue number: 0550-0004; All Lots], Impella Cp [Model or catalogue number: 0048-0004; All Lots], Impella Cp With Smart Assist [Model or catalogue number: 0048-0044; All Lots] |
|
| 22 Mar 2024 |
Legency Remedies Private Limited Sodium Chloride Irrigation Solution 0.9% w/v, Sodium Chloride Inhalation Solution 0.9% w/v, Sodium Chloride Eyewash Solution 0.9% w/v |
|
| 22 Mar 2024 |
Baxter Healthcare Corporation HDS Traction Boot II [REF: AR-6529-23] |
|
| 22 Mar 2024 |
Randox Laboratories Ltd. Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution [Catalog No.: IT2691; GTIN: 05055273204032; Batch No./Lot No.: 647343/2154IT-2158IT, 647342/2154IT-2158IT, 634886/2112IT-2116IT, 634887/2112IT-2116IT, 627224/2112IT-2116IT, 627222/2112IT-2116IT] |
|
| 22 Mar 2024 |
Vyaire Medical, Inc. Recalls AirLife Manual Resuscitators Due to Manufacturing Defect That Can Lead to Injury or Death |
|
| 22 Mar 2024 |
Preat Corp Preat Nobel Active/Conical-compatible RP Titanium Blank [REF 9000967; Model Number: 9000967 UDI-DI code: 00842092165867 Lot Numbers: 235650, 234294, 233667, 233885, 233439, and 231489] |
|
| 22 Mar 2024 |
Zimmer Inc (Sponsored by Zimmer Biomet Pty Ltd) Zimmer Periarticular Locking Plate System, Distal Lateral Fibula Locking Plate [Item number: 47-2357-018-04; Description: ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile; Lot number: 64396818] |
|
| 22 Mar 2024 |
Shimadzu Corp (Sponsored by Shimadzu Medical Systems Oceania Pty Ltd) Shimadzu CVS System - Trinias units [Reference number: SVHI-E24C006; Serial numbers: M1E585D57001, M1E58C157001] |
|
| 22 Mar 2024 |
Immucor Inc (Sponsored by Paragon Care Group Australia Pty Ltd trading as Immulab) Panocell – 10 Reagent Red Blood Cells [Lot number: 03797; Reference number: 0003032; UDI-DI number: 10888234000396; Expiry date: 22 Mar 2024] |
|
| 22 Mar 2024 |
Think Surgical, Inc. Assembly, Array Guide TMINI [REF: 109101] |
|
| 22 Mar 2024 |
In2Bones, SAS I.B.S 6.5-C Compression screw - diam 6.5mm lg 75mm [Part Number S65 ST175] |
|
| 22 Mar 2024 |
Thommen Medical AG impression coping, repositionable, short, screw-retained, PF 4.0 |
|
| 21 Mar 2024 |
Medtronic Inc. Abre Venous Self-expanding Stent System |
|
| 21 Mar 2024 |
Siemens Healthcare Diagnostics, Inc. DCA Systems HbA1c Reagent Kit [Siemens Material Number: 10311134; UDI/DI: 00630414532806; Lot: 9640093, 0645103, 0648103, 0648103, 0648103, 0637093, 0641093, 0642093, 0647103, 0653103, 0655103] |
|
| 21 Mar 2024 |
InfuTronix, LLC Voluntary Removal Announcement for the InfuTronix Nimbus Ambulatory Infusion Pump System |
|
| 21 Mar 2024 |
Randox Laboratories Ltd (Sponsored by Randox Australia Pty Ltd) Evidence MultiSTAT - IVD [Catalogue number: EV4115] |
|
| 21 Mar 2024 |
Coloplast A/S Ureteral Dilator (Ch/Fr 12-14, length 48 cm) [Model/Catalogue/part numbers: RBD014] |
|
| 21 Mar 2024 |
Sarnova HC, Llc 1) Curaplex Nasal Intubation Kit with 6mm Endotrol Tube [Item Number: 023060S]; 2) Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube [Item Number: 023070S] |
|
| 21 Mar 2024 |
"Mckesson Medical-Surgical Inc. Corporate Office 1) Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis; 2) Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult; 3) Steris Corporation Endo Cleaning Indicator VERIFY"" RESITEST""; 4) Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mL; 5) Abbott Point of Care Control Control i-STAT Level 3 1.7 mL" |
|
| 20 Mar 2024 |
UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication |
|
| 20 Mar 2024 |
威利魯西有限公司 Willy Rüsch GmbH 醫用掌上型壓力泵 Endotest |
|
| 20 Mar 2024 |
Resmed Pty Ltd Astral 100 and Astral 150 ventilators |
|
| 20 Mar 2024 |
美敦力公司 Medtronic Inc. 壓力泵裝置 |
|
| 20 Mar 2024 |
美國瑞毅醫療科技有限公司 Wright Medical Technology, Inc. 全踝關節手術器械包 INFINITY Total Ankle System Instruments |
|
| 20 Mar 2024 |
碧迪公司 Becton, Dickinson and Company 酵母菌鑒定板 BD Phoenix YEAST ID |
|
| 19 Mar 2024 |
Medtronic Hugo Robotic-Assisted Surgery (RAS) System: Hugo RAS Tower and Surgeon Console |
|
| 19 Mar 2024 |
Sleepnet Corporation Issues Worldwide Recall of CPAP and BIPAP Masks with Magnets Due to Potential Interference with Certain Medical Implants |
|
| 18 Mar 2024 |
One Lambda Inc (Sponsored by Thermo Fisher Scientific Australia Pty Ltd) LABType SSO Typing Tests and LABType XR/CWD DNA Typing Kits |
|
| 18 Mar 2024 |
Hangzhou Fanttest Biotech Co Ltd (Sponsored by Australia Health Products Central Pty Ltd) Fanttest COVID-19/lnfluenza A&B Antigen Test Kit |
|
| 18 Mar 2024 |
Medartis AG (Sponsored by Medartis Australia & New Zealand Pty Ltd) Medartis APTUS Wrist Plates |
|
| 18 Mar 2024 |
MEDLINE INDUSTRIES, LP - Northfield CVS Health Waterproof Wound Tracking Dressing |
|
| 18 Mar 2024 |
Retractable Technologies, Inc. EasyPoint Needle |
|
| 18 Mar 2024 |
ResMed Corp ResScan 7.0 on AirSense 11 AutoSet device |
|
| 18 Mar 2024 |
Baxter Healthcare Corporation CLEARLINK Non-DEHP Solution Set Luer Lock Adapter |
|
| 18 Mar 2024 |
Exactech Australia Pty Ltd Equinoxe Shoulder reverse total shoulder (rTSA) UHWMPE and anatomic total shoulder (aTSA) UHMWPE devices |
|
| 18 Mar 2024 |
Medtronic Australasia Pty Ltd Cannulae Devices |
|
| 18 Mar 2024 |
Siemens Healthcare Pty Ltd Atellica CH analysers |
|
| 18 Mar 2024 |
Waldemar Link GmbH & Co. KG (Mfg Site) SPII Model Lubinus |
|
| 15 Mar 2024 |
奧森多臨床診斷(美國)股份有限公司 Ortho Clinical Diagnostics (QuidelOrtho) 生化通用質控品 [涉及產品型號、規格及批次: 生化通用質控品I: 質控品I 12x3mL; 稀釋液 12x5mL; 生化通用質控品II: 質控品II 12x3mL; 稀釋液 12x5mL; 識別信息: 生化通用質控品 I批次: Q1174; 生化通用質控品 II 批次: R1176] |
|
| 15 Mar 2024 |
富士瑞必歐株式會社 FUJIREBIO INC. 涎液化糖鏈抗原KL-6校準液 [涉及產品型號、規格及批次: 1瓶 x 3濃度 (1.5mL/瓶); 識別信息: 批號: FYX4083C; FYX4114C] |
|
| 15 Mar 2024 |
上海醫光儀器有限公司 醫用內窺鏡冷光源 [涉及產品型號、規格及批次: LG100] |
|
| 15 Mar 2024 |
生命科技控股私人有限公司 Life Technologies Holdings Pte Ltd 基因測序系統 Personal Genome Machine Dx System [涉及產品型號、規格及批次: PGM Dx] |
|
| 15 Mar 2024 |
上海諾幫生物科技有限公司 生物玻璃骨填充材料 [涉及產品型號、規格及批次: 夥粒狀: 1g; 識別信息: 01230401、01230601、01231104] |
|
| 15 Mar 2024 |
Avanos Recalls MIC Gastric – Jejunal Feeding Tube Kits Containing Sterile Water Based Products Under Recall by Nurse Assist |
|
| 15 Mar 2024 |
Medos International Sarl CERENOVUS CEREBASE DA Guide Sheath |
|
| 15 Mar 2024 |
Device Technologies Australia Pty Ltd Unimax Medical Systems – Detachable Endo Pouch |
|
| 15 Mar 2024 |
Siemens Healthcare Pty Ltd MAGNETOM Biograph mMR [Product code: 10433372] |
|
| 15 Mar 2024 |
Randox Australia Pty Ltd Calibration Serum Level 3 [Catalog Number: CAL2351; GTIN: 05055273200966; Batch Numbers: 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE] |
|
| 15 Mar 2024 |
Smiths Medical Asd, Inc. 1) Medfusion Model 4000 Syringe Infusion Pump; 2) Medfusion Syringe Infusion Pumps |
|
| 15 Mar 2024 |
邁柯唯重症監護有限公司 Maquet Critical Care AB 呼吸機 [涉及產品型號、規格及批次: SERVO-U, SERVO-AIR] |
|
| 14 Mar 2024 |
Covidien llc Covidien Auto Suture Structural Balloon Trocar & Covidien Auto Suture Blunt Tip Trocar |
|
| 14 Mar 2024 |
Baxter Healthcare Corporation STERIS Boot Assembly, Traction Device, OT 1000 |
|
| 14 Mar 2024 |
Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 [UDI-DI: 00811505030122; Software versions: 5.2.1/5.2.2] |
|
| 14 Mar 2024 |
Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 [UDI-DI: 00811505030122; Software versions: 5.0.1 and earlier] |
|
| 14 Mar 2024 |
Philips Mobile Diagnostic wDR 2.x Systems |
|
| 14 Mar 2024 |
Invacare Rea AB (Sponsored by Invacare Australia Pty Ltd) NordBed Kid (Paediatric Bed) |
|
| 14 Mar 2024 |
Howmedica Osteonics Corporation Trident II Clusterhole HA Acetabular Shell |
|
| 14 Mar 2024 |
Wright Medical Technology Inc. MIS Sterile Instrument Pack |
|
| 14 Mar 2024 |
Peter Lazic Gmbh L-Aneurysm Clip TITANIUM Paddle-Clip |
|
| 14 Mar 2024 |
Peter Lazic Gmbh D-Clip Standard/Mini Applier |
|
| 13 Mar 2024 |
Olympus Medical Systems Corp. Various Olympus Medical Endoscopes |
|
| 13 Mar 2024 |
Cardinal Health Cardiovascular, Bypass and Hepatobiliary Packs |
|
| 12 Mar 2024 |
DiaMed GmbH Reagents for antibody screening tests |
|
| 12 Mar 2024 |
Symbios Orthopédie S.A. ORIGIN knee system |
|
| 12 Mar 2024 |
NuVasive Specialized Orthopedics, Inc. MAGEC System (MAGEC X) |
|
| 12 Mar 2024 |
Epic Systems Corporation. Epic's Regulated Decision Support Framework |
|
| 12 Mar 2024 |
Draeger Perseus A500 (MK06000) |
|
| 12 Mar 2024 |
SYNOVIS LIFE TECHNOLOGIES INC. (ST. PAUL) Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch [FA-2024-008] (FSN) |
|
| 12 Mar 2024 |
B. Braun Medical Ltd NOVOSYN |
|
| 12 Mar 2024 |
Abbott Recalls HeartMate Touch Communication System for Unintentional Pump Start and Stop |
|
| 12 Mar 2024 |
Synovis Life Technologies, Inc. (Baxter International Inc.) Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch [FA-2024-010] (FSN) |
|
| 12 Mar 2024 |
Synovis Life Technologies, Inc. (Baxter International Inc.) Peri-Guard Repair Patch and Supple Peri-Guard Repair Patch [FA-2024-010] (Letter) |
|
| 11 Mar 2024 |
Synovis Life Technologies, Inc. A Subsidiary Of Baxter International Inc Baxter Flo-Thru, Flo-Rester and Vascular Probe |
|
| 11 Mar 2024 |
Philips Medical Systems Philips CareEvent & Patient Information Center iX (PIC iX) |
|
| 11 Mar 2024 |
Agfa Australia Pty Ltd DX-D100 Mobile |
|
| 11 Mar 2024 |
Bruder Healthcare Company Thermalon Sinus Mask |
|
| 11 Mar 2024 |
Philips Electronics Australia Ltd Incisive CT |
|
| 11 Mar 2024 |
廣州伽美化妝品有限公司 康瑞保傷口護理軟膏 |
|
| 08 Mar 2024 |
Waldemar Link GmbH & Co. KG (Mfg Site) Embrace Drill Tower, Wedged (25mm) [Item Number: 645-081/62; UDI/DI: 04026575534715], Embrace Drill Tower, Standard/Lateral (25mm) [Item Number: 645-081/63; UDI/DI: 04026575534722] |
|
| 08 Mar 2024 |
Randox Laboratories Ltd Microalbumin Calibrator Series (mALB CAL) [Catalogue number: MA1567; Batch / Lot number: 619282 / 1094MA-1098MA, Catalogue number: MA2426; Batch / Lot number: 602114/1083MA-1087MA, 636645/ 1108MA-1112MA, 662429/ 1083MA-1087MA], Microalbumin Liquid Control [Catalogue number: MA1361; Batch / Lot number: 631698/ 1102MA&1103MA], Liquid Urine Control - Level 3 [Catalogue number: UC5075; Batch / Lot number: 1298UC] |
|
| 08 Mar 2024 |
Medicina Limited ENFit Double Lumen Replogle Tube [Product code: NF02L; Batches: 19I09004, 21F18002, 23C03045, 23C03046] |
|
| 08 Mar 2024 |
Luminex Corporation NxTAG Respiratory Pathogen Panel [Catalog/Part Number: I051C0449] and NxTAG Respiratory Pathogen Panel + SARS-CoV-2 [Catalog/Part Number: I056C047] |
|
| 08 Mar 2024 |
Waldemar Link GmbH & Co. KG Link OptiStem, Rasp Handle Stainless Steel [UDI-DI: 04026575284658; Lot or serial number: C010108, C151519] |
|
| 08 Mar 2024 |
CONMED Corporation Hip Preservation System, Signature Series 5.5mm HPS Spherical Bur [Catalog no.: HPS-HB11; Lot Codes: 1349719, 1349720, 1349721, 1349722, 1349723] |
|
| 08 Mar 2024 |
Aidence Veye Lung Nodules 3.22.0 [UDI-DI: B865VEYELUNGNOD0322X0] |
|
| 08 Mar 2024 |
Canon Medical Systems Corporation Vantage Orian [Model or catalogue number: MRT-1550/YP, MRT-1550/YX; Lot or serial number: YXB2182001, YPA1982001] |
|
| 08 Mar 2024 |
Medline Industries, Lp Norm Saline 0.9% Sodium Chlor 110ml Ster Cup [Model or catologue number: DYND40540; Multiple Lot or serial number], Normal Saline F/Irrig 100ml Screw Top Bt [Model or catologue number: RDI30296; Multiple Lot or serial number], Solution,Saline,Sterile,500 Ml, Bottle [Model or catologue number: DYND500MLS; Multiple Lot or serial number], Ster Water F/Irr&Suct Foil Lid Cup 110ml [Model or catologue number: DYND40570; Multiple Lot or serial number], Sterile Water F/Irrig 100ml Screw Top Bt [[Model or catologue number: RDI30295; Multiple Lot or serial number] |
|
| 08 Mar 2024 |
Cook Medical Dilators - Coons Taper; Entuit Secure Adjustable Gastrointestinal Suture Anchor Sets; Chiba Biopsy Needles |
|
| 08 Mar 2024 |
Howmedica Osteonics Corp. X3 TRIATHLON CS INSERT; NO 3 TRIATHLON TS PLUS TIB INS X3 POLY ; NO 4 TRIATHLON TS PLUS TIB INS X3; |
|
| 08 Mar 2024 |
Medtronic Neurosurgery Recalls Duet External Drainage and Monitoring System Catheter Tubing due to a Potential for the Catheter Disconnection from the Patient Line Stopcock Connectors |
|
| 08 Mar 2024 |
Ventec Life Systems Recalls VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) for Manufacturing Issue with Bonded Spiral Wrap |
|
| 08 Mar 2024 |
Olympus (Gyrus ACMI, Inc.) OLYMPUS Soltive SuperPulsed Laser System (including SOLTIVE PRO Thulium Fiber Laser System (EGTFL-SLS) and SOLTIVE PREMIUM Thulium Fiber Laser System (EGTFL-PLS) |
|
| 08 Mar 2024 |
Beckman Coulter DxA 5000 Automation System |
|
| 08 Mar 2024 |
SYNOVIS LIFE TECHNOLOGIES INC. (ST. PAUL) (SRN US-MF-000028264) (Baxter) Flo-Rester, Flo-Thru, Vascular Probe, Ma Recette. |
|
| 08 Mar 2024 |
Baxter Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, Vascular Probe Intravascular Probe, Ma Recette Mitonnee Leg MP 6. |
|
| 07 Mar 2024 |
Philips Electronics Australia Ltd Allura Xper, Allura Centron, and Azurion Systems |
|
| 07 Mar 2024 |
Beckman Coulter Inc (Sponsored by Beckman Coulter Australia Pty Ltd) DxI 9000 Access Immunoassay Analyser - IVD [Product Code/Catalogue Number: C11137; Multiple serial numbers; Software: 1.16.2 and below] |
|
| 07 Mar 2024 |
Elekta Instrument AB (Sponsored by Elekta Pty Ltd) Disposable Biopsy Needle Kit [Product Description: 911933; Batch Number: 837838839] |
|
| 07 Mar 2024 |
Paragon 28, Inc. 1) Phantom TTC Nail, 10.0 X 200mm, Right; 2) Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L; 3) Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R |
|
| 07 Mar 2024 |
Invacare Corporation Invacare Homecare Series Bed and Invacare G-Series Beds [Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW] |
|
| 07 Mar 2024 |
GE Healthcare MAC VU360 V1.02 SP05 12 Lead ECG Post Acquisition Preview Screen [Product number: 2030360-001] |
|
| 07 Mar 2024 |
Baxter Healthcare Recalls ExactaMix Pro 1200 and Pro 2400 Due to a Software Error |
|
| 06 Mar 2024 |
Respironics Inc (Sponsored by Philips Electronics Australia Ltd) Trilogy Evo, Trilogy Evo O2, Trilogy EV300 |
|
| 05 Mar 2024 |
富士膠片醫療健康株式會社 數字化彩色超聲波診斷裝置 |
|
| 05 Mar 2024 |
美國雅培公司 Abbott Laboratories 肌紅蛋白測定試劑盒 (化學發光微粒子免疫檢測法) ARCHITECT STAT Myoglobin Reagent Kit |
|
| 05 Mar 2024 |
德培依(美國)骨科股份有限公司 DePuy Orthopaedics, Inc. 半肩關節系統 Global Shoulder System |
|
| 05 Mar 2024 |
德恩歐美達公司 Datex-Ohmeda, Inc. 蒸發器 |
|
| 05 Mar 2024 |
西門子醫學診斷股份有限公司 Siemens Healthcare Diagnostics Inc. 甘油三酯測定試劑盒(GPO-PAP法) |
|
| 04 Mar 2024 |
Synthes (USA) Products LLC Multiple medical devices |
|
| 04 Mar 2024 |
Aesculap Inc DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU; DISP.HASSON TROCAR 10/110MM, Product Code EK230SU; DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU; DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU; DISP.HASSON TROCAR 12/110MM, Product Code EK240SU |
|
| 04 Mar 2024 |
Covidien llc (Sponsored by Medtronic Australasia Pty Ltd) Covidien Auto Suture Structural Balloon Trocar & Covidien Auto Suture Blunt Tip Trocar |
|
| 04 Mar 2024 |
OrthoPediatrics Corp (Sponsored by Orthopediatrics AUS Pty Ltd) Wrench, Cannulated Socket 10mm, Wrench, Combo 10mm, Wrench, Swivel 10mm, Orthex Wrench 7mm |
|
| 04 Mar 2024 |
Smiths Medical ASD Inc (Sponsored by Smiths Medical Australasia Pty Ltd) CADD-Solis Ambulatory Infusion Pumps |
|
| 04 Mar 2024 |
Smiths Medical ASD Inc (Sponsored by Smiths Medical Australasia Pty Ltd) CADD-Solis Ambulatory Infusion Pumps |
|
| 04 Mar 2024 |
Caesarea Medical Electronics Limited (Sponsored by Becton Dickinson Pty Ltd) BD BodyGuard MicroSets |
|
| 04 Mar 2024 |
Avanos Medical, Inc. 1) MIC* Gastric-Jejunal Feeding Tube Kits; 2) MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors |
|
| 04 Mar 2024 |
Qiagen Pty Ltd EZ2 Connect MDx instrument |
|
| 04 Mar 2024 |
Olympus Corporation of the Americas Colonoscope |
|
| 04 Mar 2024 |
Waldemar Link GmbH & Co. KG (Mfg Site) LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell |
|
| 04 Mar 2024 |
Acumed LLC Acu-Loc and Acu-Loc 2 bone plates, screws and accessories |
|
| 04 Mar 2024 |
United Orthopedic Corporation USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray; USTAR II Knee System Cemented curved stem, RHS, Non Coated; USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray |
|
| 04 Mar 2024 |
Gyrus ACMI, Inc. (Sponsored by Olympus Australia Pty Ltd) Olympus Soltive Premium SuperPulsed Laser System |
|
| 01 Mar 2024 |
GRAPHENANO DENTAL SL GRAPHENANO DENTAL G-CAM [Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 95 Multichroma 24LA1, REF GC00113; f) 95 Multichroma 16LB2, REF GC00131; g) 95 Multichroma 14LA2, REF GC00157; h) 95 Multichroma 20LB2, REF GC00098; i) 95 Multichroma 20LBL2, REF GC00114; j) 95 Multichroma 16LA3,5, REF GC00132; k) 95 Multichroma 14LA1, REF GC00158; l) 95 Multichroma 24LB1, REF GC00099; m) 95 Multichroma 20LA3,5, REF GC00115; n) 95 Multichroma 16LA3, REF GC00133; o) 95 Multichroma 16LC2, REF GC00091; p) 95 Multichroma 14LBL2, REF GC00134; q) 95 Multichroma 24LBL2, REF GC00092; r) 95 Multichroma 24LA3,5, REF GC00101; s) 95 Multichroma 20LA3, REF GC00117; t) 95 Multichroma 14LB1, REF GC00135; u) 95 Multichroma 24LB2, REF GC00094; v) 95 Multichroma 20LA2, REF GC00119; w) 95 Multichroma14LA3,5, REF GC00137; x) 95 Multichroma 14LC2, REF GC00095; y) 95 Multichroma 24LA3, REF GC00104; z) 95 Multichroma14LA3, REF GC00138; Mulitple Serial Number] |
|
| 01 Mar 2024 |
Follow Instructions for Safe Use of Electrical Operating Room Tables - Letter to Health Care Providers |
|
| 01 Mar 2024 |
Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication |
|
| 01 Mar 2024 |
AusDiagnostics Pty Ltd Low RNA Reagent Cassette - IVD [Catalogue number: 40331; version: 03; Batch numbers: C298133RL, C299183RL, C297907RL, C298045RL] |
|
| 01 Mar 2024 |
Carl Zeiss Meditec AG VisuMax [Device serial number: 1124489], VISUMAX 600 & VISUMAX 800 [Device serial number: 9511100017, 9511100001, 1249152, 9511100004, 9511100019, 9511100020, 9511100018] - Preventive laser source replacement |
|
| 01 Mar 2024 |
Megadyne Reiterates Intended Use Population Change for Megadyne Mega Soft Universal and Universal Plus Patient Return Electrodes |
|
| 01 Mar 2024 |
貝克曼庫爾特生物醫學股份有限公司 Beckman Coulter Biomedical GmbH 全自動樣品處理系統 DxA Automation System |
|
| 01 Mar 2024 |
貝克曼庫爾特(美國)股份有限公司 Beckman Coulter, Inc. 不飽和鐵結合力測定試劑盒 (Nitroso-PSAP法) UIBC |
|
| 01 Mar 2024 |
辛迪思有限公司 Synthes GmbH 髓內釘系統 Intramedullary Nailing System、矯形外科（骨科）手術器械-擴髓，灌注，吸引系統 RIA-Reamer Irrigator Aspirator、金屬髓內釘系統Metallic Intramedullary Nailing System、椎間融合器 OPAL [涉及產品型號、規格及批次: (產品型號: 08.803.231S; 04.008.378S; 04.037.144S; 04.037.944S; 314.746S; 識別信息(批號): 427P153; 41P2222; 4489P98; 3744P37; H802995; H803000; H803020; H830033; UDI/ DI: 7611819318489; 10886982087331; 10886982096562; 10886982098047; 10886982189080)] |
|
| 01 Mar 2024 |
Stryker Canada ULC Erich Arch Bar Roll and Obwegeser Raspatory |
|
| 01 Mar 2024 |
CooperSurgical Origio Sperm Wash Media [Part number: 84055060A, 84055060D, and 84051010A; lots: 230922-018006, 230922-018008, and 230922-018009] |
|
| 29 Feb 2024 |
Thoratec Corporation Heartmate 3 LVAS Kits with Heartmate 3 Outflow Grafts & Heartmate II LVAS Kits with Heartmate II Outflow Grafts |
|
| 29 Feb 2024 |
Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire |
|
| 29 Feb 2024 |
Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication |
|
| 29 Feb 2024 |
Abbott Molecular, Inc. Abbott Vysis MDM2 / CEP 12 FISH Probe Kit [REF: 01N15-010; GTIN: 00884999035362; Lot: #381146, #381870, #382179 #387021, #528081], Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe [REF: 01N34-020; GTIN: 00884999000766; Lot: #522756], Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe [REF: 01N33-020; GTIN: 00884999000759; Lot: #381411], Abbott Vysis PTEN/CEP 10 FISH Probe Kit [REF: 04N62-020; GTIN: 00884999009301; Lot: #382133], Abbott Vysis TelVysion 1p SpectrumGreen Probe [REF: 05J03-001; GTIN: 00884999009882; Lot: #381111], Abbott Vysis TelVysion 4P SpectrumGreen Probe [REF: 05J03-004; GTIN: 00884999009912; Lot: #381102], Abbott Vysis TelVysion 22q SpectrumOrange Probe [REF: 05J04-022; GTIN: 00884999010451; Lot: #530242], Wash station: M1000 Wash Station Assembly & DITI Slide [REF: 04J72-28; UDI-DI: 00884999006676] |
|
| 29 Feb 2024 |
NxStage MDS Corporation NxStage Cartridge Express with Speedswap [Catalog No. CAR-535; UDI-DI: M535CAR5350; Lots: 20878001, 30978013, 30978032, 31178011, 31178019] |
|
| 29 Feb 2024 |
Qiagen GmbH (Sponsored by Qiagen Pty Ltd) therascreen MGMT Pyro Kit - IVD [Catalogue number: 971061; Lot numbers: 175030723, 175034299] |
|
| 29 Feb 2024 |
Wright Medical Technology Inc (Sponsored by Stryker Australia Pty Ltd) HV Sterile Screws [Multiple products] |
|
| 29 Feb 2024 |
Olympus Corporation of the Americas Recalls Laser-Compatible Olympus Bronchoscopes for Risk of Endobronchial Combustion and Patient Burns |
|
| 29 Feb 2024 |
Medtronic Neurosurgery Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites |
|
| 28 Feb 2024 |
RaySearch Laboratories AB (publ) RayStation/RayPlan 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A |
|
| 28 Feb 2024 |
Roche Elecsys Troponin T hs, Elecsys Troponin T hs STAT |
|
| 28 Feb 2024 |
BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication |
|
| 28 Feb 2024 |
Avanos Medical, Inc. MIC* Gastric-Jejunal Feeding Tube Kits |
|
| 28 Feb 2024 |
Beaver-Visitec International Inc (Sponsored by Beaver-Visitec International Australia Pty Ltd) Irrigation Handle (20/SP) |
|
| 28 Feb 2024 |
Shenzhen Lutejiacheng Technology Co.,Ltd. Wearable Breast Pumps [Model or Catalogue Number: S9 M1 S9 PRO S12 PRO S12] |
|
| 27 Feb 2024 |
Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment Due to Potential Lack of Sterility |
|
| 27 Feb 2024 |
EMS (ELECTRO MEDICAL SYSTEMS S.A.) WATER Bottle [EG-121], NIGHT CLEANER Bottle [EG-120], PIEZON Bottle [EG-111], CLEANER Bottle [EG-1000] |
|
| 27 Feb 2024 |
AusDiagnostics Step 2 Plates for Respiratory Pathogens 24-well |
|
| 27 Feb 2024 |
北京綠源恒泰醫療器械有限公司 臂式電子血壓計 |
|
| 27 Feb 2024 |
Philips DIVA 24 Inch Widescreen LCD Touch Display |
|
| 27 Feb 2024 |
Ivoclar Vivadent AG Bluephase Style 100-240 V |
|
| 27 Feb 2024 |
Intersurgical Ltd. FILTANEB, CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE NONVENTED MASK KIT WITH FILTER AND TUBE, 2.1M |
|
| 27 Feb 2024 |
Thoratec Corporation 1) HEARTMATE 3 LVAS KITS & HEARTMATE 3 OUTFLOW GRAFTS; 2) HEARTMATE II LVAS KITS & HEARTMATE II OUTFLOW GRAFTS |
|
| 27 Feb 2024 |
Vyaire Medical AirLife Adult Manual Resuscitators |
|
| 27 Feb 2024 |
MEDLINE INDUSTRIES, LP - Northfield Multiple kits, trays, and packs |
|
| 27 Feb 2024 |
Biomet Spain Orthopaedics, S.L. Biomet Tibial Modular System |
|
| 27 Feb 2024 |
PEROUSE MEDICAL (VYGON) POLYPERF SAFE |
|
| 27 Feb 2024 |
Randox Laboratories Ltd Randox IgM reagent |
|
| 26 Feb 2024 |
MRP, LLC dba Aquabiliti AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807 |
|
| 26 Feb 2024 |
Medagent Inc Rebstock Holding rod for fixation |
|
| 26 Feb 2024 |
Ventec Life Systems, Inc. VOCSN Patient Breathing Package |
|
| 26 Feb 2024 |
IMPULSE DYNAMICS USA INC OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices |
|
| 26 Feb 2024 |
MEDLINE INDUSTRIES, LP - Northfield MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES |
|
| 26 Feb 2024 |
Fresenius Medical Care AG & Co KGaA Stay Safe Catheter Extension Luer-Lock 25cm, 32cm & 40cm |
|
| 26 Feb 2024 |
HeartSine Technologies Ltd HeartSine samaritan PAD |
|
| 26 Feb 2024 |
PTW-FREIBURG Software VERIQA |
|
| 26 Feb 2024 |
Alphatec Spine, Inc. IdentiTi ALIF Standalone Interbody System |
|
| 26 Feb 2024 |
EMD Millipore Corporation Schiff Reagent, Hotchkiss-McManus |
|
| 26 Feb 2024 |
W.L. Gore & Associates, Inc. GORE VIABIL Short Wire Biliary Endoprosthesis |
|
| 26 Feb 2024 |
Zyno Medical LLC Zyno Medical Z800 Large Volume Infusion Pumps |
|
| 26 Feb 2024 |
Randox Laboratories Ltd (Sponsored by Randox Australia Pty Ltd) CYSTATIN C CALIBRATOR and CONTROL LEVEL 2 and 3 |
|
| 26 Feb 2024 |
Diamed GmbH (Sponsored by Bio-Rad Laboratories Pty Ltd) Anti-k |
|
| 26 Feb 2024 |
Beckman Coulter Inc (Sponsored by Beckman Coulter Australia Pty Ltd) Access Substrate 4 x 130ml [Includes the Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems; Part Number: 81906; Multiple Lot and Expiry Dates] |
|
| 26 Feb 2024 |
3M Company (Sponsored by 3M Australia Pty Ltd) 3M Tube Securement Device |
|
| 26 Feb 2024 |
Abiomed, Inc. Automated Impella Controller (AIC) |
|
| 23 Feb 2024 |
3M Company - Health Care Business 3M Specialty Blade Assembly used with used with 3M Surgical Clipper |
|
| 23 Feb 2024 |
Bio-Rad Laboratories Inc (Sponsored by Bio-Rad Laboratories Pty Ltd) QXDx BCR-ABL %IS Kit [Product UDI: 03610521171980; Catalogue Number:12006134; Serial/Lot Numbers: 64549423, 64556965, 64562663, 64572053; Software Version: v1.7.4] |
|
| 23 Feb 2024 |
Fujifilm Healthcare Americas Corporation Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0, Synapse CV 6. with AR |
|
| 22 Feb 2024 |
Boston Scientific Corporation CRBS POLARSHEATH STEERABLE SHEATH [Material number: M004CRBS3050; Batch Number: 32895945, 32895947, 32903274, 32903275, 32903276, 32903277, 32903278, 32903340, 32999267, 33000331, 33000333, 33000334, 33000337, 33000338, 33000339, 33052646, 33052647, 33052648, 33052649, 33061576, 33171976] |
|
| 22 Feb 2024 |
Medtronic Xomed, Inc. NIM EMG Endotracheal Tube [Model Number: 8229306; UDI: 00763000745813, 00643169789524, 00643169358690, 00763000882389, Model Number: 8229307; UDI: 00763000745820, 00643169358713, 00643169789531, 00763000882396, Model Number: 8229308; UDI: 00763000745837, 00643169358737, 00643169789548], CONTACT EMG Endotracheal Tube [Model Number: 8229506; UDI: 00643169789555, Model Number: 8229507; UDI: 00643169789562, 00763000745851, Model Number: 8229508; UDI: 00643169789579, 00763000745868] |
|
| 22 Feb 2024 |
Sonictec Pty Ltd Fanttest COVID-19/Influenza A&B Antigen Test Kit [Product Identifiers: I2210004 to I2210006, I2212002 to I2212006 and all batches after; Expiry Date: 09/2023 to 05/2025] |
|
| 22 Feb 2024 |
Mölnlycke Mölnlycke Procedure Trays |
|
| 22 Feb 2024 |
BD BD MAX Enteric Viral Panel-NR [REF: 443987; Lot Numbers: 3081625] |
|
| 22 Feb 2024 |
Medivance Inc (Sponsored by Bard Australia Pty Ltd) Neonatal ArcticGel Pads |
|
| 22 Feb 2024 |
Olympus Soltive SuperPulsed Laser System |
|
| 22 Feb 2024 |
Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication |
|
| 21 Feb 2024 |
Medtronic Covidien Signia Small Diameter Curved Tip Intelligent Reload |
|
| 21 Feb 2024 |
麥迪萬斯股份有限公司 Medivance Inc 醫用控溫毯 ArcticGel Pads |
|
| 21 Feb 2024 |
Health Canada: Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) for the Treatment of Peripheral Arterial Disease (PAD) and the Potential Risk of Long-Term All-Cause Mortality |
|
| 20 Feb 2024 |
Joerns Healthcare Ltd (Sponsored by Enable Lifecare PTY LTD) Oxford Classic Floor Lifter |
|
| 20 Feb 2024 |
深圳鴻益生物科技有限公司 醫用紅外額溫計 |
|
| 19 Feb 2024 |
HeartSine Technologies Ltd HeartSine samaritan PAD |
|
| 19 Feb 2024 |
B. Braun Medical, Inc. Epidural tray |
|
| 19 Feb 2024 |
Canon Medical System, USA, INC. X-ray system and INFX-8000F |
|
| 19 Feb 2024 |
AMD Medicom Inc. HENRY SCHEIN EARLOOP MASKS LEVEL 3 (BLUE) |
|
| 19 Feb 2024 |
Boston Scientific Corporation EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 |
|
| 19 Feb 2024 |
Mobius Imaging, LLC. Airo Mobile CT System |
|
| 19 Feb 2024 |
Medtronic Inc. Abre Venous Self-expanding Stent System |
|
| 19 Feb 2024 |
Windstone Medical Packaging, Inc. Aligned Medical Solutions |
|
| 19 Feb 2024 |
Cardinal Health Dover 100% Silicone Foley Catheters and others |
|
| 19 Feb 2024 |
Medos International Sarl Cerebase Da Guide Sheath |
|
| 19 Feb 2024 |
Baxter Healthcare Corporation Baxter Exactamix Pro 1200; Baxter Exactamix Pro 2400 |
|
| 19 Feb 2024 |
Stryker, Inc. Trevo Pro 18 Microcatheter and Trevo Trak 21 Microcatheter |
|
| 19 Feb 2024 |
Howmedica Osteonics Corporation Triathlon Total Knee Systems |
|
| 16 Feb 2024 |
Quidel Corporation Sofia 2 Flu + SARS Antigen FIA [UDI-DI: 30014613339229; Lot number : 709083] |
|
| 16 Feb 2024 |
SEDECAL SA MobileDiagnost wDR [Model numbers: 712001, 712002, 712004, 712006, and 712007] |
|
| 16 Feb 2024 |
Fujifilm Healthcare Americas Corporation Synapse Picture Archiving And Communications Systems [Model or catalogue number: SYNAPSE PACS VERSION 7.1.X SYNAPSE PACS VERSION 7.2.X SYNAPSE PACS VERSION 7.3.0X SYNAPSE PACS] |
|
| 16 Feb 2024 |
Mediplas Respiratory Products Sdn Bhd (Sponsored by Swirl Technologies Pty Ltd T/A Parker Healthcare) Disposable Analgesia Breathing Circuit 3.0m EXPANDABLE 22mmID Tubing, Filter, Hand piece with One-way Valve and Mouthpiece [Batch Number: 1272308; Part Number: MC/3200/F] |
|
| 16 Feb 2024 |
Origio A/S (Sponsored by Origio Australasia Pty Ltd) CooperSurgical SupraSperm 100 Gradient Medium [Part Number: 10970060A; Lot Number: 230331-013796] |
|
| 16 Feb 2024 |
Shimadzu Corp (Sponsored by Shimadzu Medical Systems Oceania Pty Ltd) Xray Screening table handle [S/N: MQC3548CA001] |
|
| 16 Feb 2024 |
Smiths Medical ASD Inc paraPAC plus Ventilator [Model: 310; Product Code: P310NAU] |
|
| 16 Feb 2024 |
卡麥德醫療器械有限公司 [奧林巴斯貿易(上海)有限公司] 内窺鏡用送水泵 [涉及産品型號、規格及批次: MAJ-1606; 批次號: 20252700 、20256336 、20256338、20261228 、20276938] |
|
| 16 Feb 2024 |
Phadia AB Phadia 200 and Phadia 200 Software 1.6.12 [Material Number: 12-4300-00] |
|
| 15 Feb 2024 |
Wallac Oy Vanadis View Plate [Product Number: 3224-0010; Product Lot Number: 1074676201; UDI: (01)06438147370511(17)240229(10)746762, Product Lot Number: 1074767501; UDI: (01)06438147370511(17)240331(10)747675, Product Lot Number: 1074868601; UDI: (01)06438147370511(17)240531(10)748686, Product Lot Number: 1074868701; UDI: (01)06438147370511(17)240531(10)748687] |
|
| 15 Feb 2024 |
Meyra GmbH iCHAIR SKY electric wheelchair |
|
| 15 Feb 2024 |
Medtronic NIM EMG Endotracheal Tube [Model Number: 8229306; UDI: 00763000745813, 00643169789524, 00643169358690, 00763000882389, Model Number: 8229307; UDI: 00763000745820, 00643169358713, 00643169789531, 00763000882396, Model Number: 8229308; UDI: 00763000745837, 00643169358737, 00643169789548], CONTACT EMG Endotracheal Tube [Model Number: 8229506; UDI: 00643169789555, Model Number: 8229507; UDI: 00643169789562, 00763000745851, Model Number: 8229508; UDI: 00643169789579, 00763000745868] |
|
| 15 Feb 2024 |
Medtronic DLP Vessel Cannula [Model Number: 30000, Lot Number: 2023020890, 202305C126, 2023020889] |
|
| 15 Feb 2024 |
Medtronic LINQ II Insertable Cardiac Monitoring Systems [Model: LNQ22] |
|
| 15 Feb 2024 |
Waldemar Link GmbH & Co. KG SPII Model Lubinus, Hip Prosthesis Stem [Multiple Model Number] |
|
| 15 Feb 2024 |
Genedrive Diagnostics Limited MT-RNR1 ID Kit [Catalog number: ID-RNR1-01; Lot number: 230311, 231501] |
|
| 15 Feb 2024 |
Musculoskeletal Transplant Foundation, Inc. AFT Straight Tube (1/2 Filled) [Product Code: MQV (bone void filler); Donor Lot number: 02921115411127], AFT Diverted Tube (3/4 Filled) [Product Code: MQV (bone void filler); UDI-DI: W4184227005T0473; Donor Lots number: 00322029241137 and 00322039641144] |
|
| 15 Feb 2024 |
Microbiologics Inc Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet) [REF: 8184; UDI-DI: 70845357041448; Lot number: 8184-68, 8184-65, 8184-66, 8184-67, 8184-69, 8184-70, 8184-71] |
|
| 15 Feb 2024 |
B. Braun Melsungen AG Original Perfusor Line [Product Code: 8255172; Batch number: 23F20E8SB4 - PVC, LL, 50 CM, Product Code: 8255253; Batch number: 23E26E8SM3, 23F06E8SM3, 23F12E8SM3 - PVC, LL, 300 CM; Product Code: 8722862; Batch number: 23E25E8SB5, 23F11E8SB5 - PVC, LL, 200 CM, Product Code: 8722960; Batch number: 23F12E8SB4, 23E31E8SB5 - PVC, LL, 150 CM] |
|
| 15 Feb 2024 |
Abiomed, Inc. Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system [Product Code: 005042 - Impella 2.5, Product Code: 005062 - Impella 5.0, Product Code: 005082- Impella LD, Product Code: 004334 - Impella RP, Product Code: 0046-0035 - Impella RP with SmartAssist, Product Code: 1000323 - RP Flex with SmartAssist, Product Codes: 0550-0008 and 1000100 - Impella 5.5 with SmartAssist, Product Code: 0048-0032 - Impella CP, Product Codes: 100080 and 0048-0045 - Impella CP with SmartAssist] |
|
| 15 Feb 2024 |
Arrow International LLC Arrow QuickFlash Radial Artery Catheterisation Kits and Sets & Arrow QuickFlash Radial Artery/Arterial Line Catheterisation Kit |
|
| 15 Feb 2024 |
Philips Medical Systems Nederland B.V. Azurion Systems [Azurion 3 (Model: 722221, 722222, 722280); Azurion 5 (Model: 722227, 722228); Azurion 7 (Model: 722223, 722224, 722225, 722226)] |
|
| 15 Feb 2024 |
Philips Medical Systems DMC GmbH (Philips North America) A) ProxiDiagnost N90 [Ref: (1)706100 (2)706110]; B) ProxiDiagnost upgrade [Ref:706150] |
|
| 15 Feb 2024 |
Wipro GE Healthcare Private Ltd. GE Healthcare neonatal incubator; Care Plus Hood Field Replacement Unit (FRU) kit; Care Plus Hood Door FRU kit; Lullaby Incubator Model Hood FRU kit; Lullaby Incubator Model Hood Door FRU kit |
|
| 15 Feb 2024 |
Abiomed, Inc. Impella catheters: (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist |
|
| 15 Feb 2024 |
Stryker Australia Pty Ltd Grays Osteotome Cup Cutting Tips [Catalogue Number: 62105100, 62105200] |
|
| 15 Feb 2024 |
Fujifilm Corporation FUJIFILM MOBILE DIGITAL X-RAY SYSTEM FDR nano |
|
| 15 Feb 2024 |
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes VA-LCP Clavicle Plate 2.7, shaft, CS1, right [Product code: 02.112.621S; Lot number: 1201P12] |
|
| 14 Feb 2024 |
Navilyst Medical, Inc. Mini-Stick Max Coaxial Microintroducer Kit |
|
| 14 Feb 2024 |
Intersurgical Ltd. Neonatal, Nasal Cannula With Curved Prongs And Tube, 2.1m |
|
| 14 Feb 2024 |
Hologic, Inc. Panther System |
|
| 09 Feb 2024 |
Ivoclar Vivadent AG 義獲嘉偉瓦登特公司 氫氧化鈣糊劑 |
|
| 09 Feb 2024 |
Carey & Co Ltd (Sponsored by Tacmed Australia Pty Ltd ) Slishman Traction Splint (Gen 2) |
|
| 09 Feb 2024 |
Arthrex Inc (Sponsored by Arthrex Australia Pty Ltd) Knotless TensionTight Button Implant System |
|
| 09 Feb 2024 |
Parker Laboratories Inc. Tensive Conductive Adhesive Gel |
|
| 09 Feb 2024 |
Synthes GmbH RIA System - Tube Assembly |
|
| 09 Feb 2024 |
Medline Industries, LP Cardiac Cath SHSC-LF; Cath Radial SHSC-LF |
|
| 09 Feb 2024 |
NeuMoDx, a QIAGEN Company HIV-1 Quant Test Strips (REF 300500) |
|
| 09 Feb 2024 |
Illustrious Healthcare Solutions Critical Care Transfer Stack (CCTS) |
|
| 09 Feb 2024 |
GE HealthCare Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator |
|
| 09 Feb 2024 |
Medtronic Surgilon Braided Nylon sutures, Sofsilk Braided Silk sutures, Monosof Monofilament Nylon Sutures, Ti-Cron Coated Braided Polyester Sutures and Steel Monofilament Stainless Steel Sutures |
|
| 09 Feb 2024 |
CooperSurgical, Inc. Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776; Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776 |
|
| 09 Feb 2024 |
Brasseler USA I Lp Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023 |
|
| 09 Feb 2024 |
Globus Medical, Inc. ExcelsiusGPS Cannula A, 9mm x 250mm |
|
| 09 Feb 2024 |
Ivoclar Vivadent, Inc. Article No. NA6050411, Valiant PhD No. 1 Econo |
|
| 09 Feb 2024 |
Becnkam Coulter, Inc. 貝克曼庫爾特(美國)股份有限公司 總甲狀腺素測定試劑盒(化學發光法) |
|
| 09 Feb 2024 |
株式會社 島津製作所 醫用血管造影X射線機 |
|
| 09 Feb 2024 |
奧林巴斯醫療株式會社 氣腹機 |
|
| 09 Feb 2024 |
Ortho-Clinical Diagnostics, Inc. 奧森多臨床診斷(美國)股份有限公司 全自動免疫分析儀;全自動生化免疫分析儀 |
|
| 09 Feb 2024 |
Ortho-Clinical Diagnostics, Inc. 奧森多臨床診斷(美國)股份有限公司 全自動免疫分析儀;全自動生化免疫分析儀 |
|
| 09 Feb 2024 |
Siemens Healthcare Diagnostics Inc. 美國西門子醫學診斷股份有限公司 促紅細胞生成素測定試劑盒(微粒子化學發光免疫分析法) 脊柱外科手術導航系統 |
|
| 08 Feb 2024 |
Beckman Coulter Ireland, Inc. iRICELL, IQ 200 and DxU Urine Analyzers |
|
| 08 Feb 2024 |
Sunmed Holdings, LLC Dba Ventlab, LLC Airflow, SafeSpot and Horizon Resuscitators |
|
| 08 Feb 2024 |
Fujifilm Irvine Scientific, Inc. Sperm separation media [UDI-DI: 00857515006009; Lot 0000020693] |
|
| 08 Feb 2024 |
Globus Medical, Inc. 1) Globus Medical Cranial Drill with Stop, 2.40mm [Ref : 6143.1834S]; 2) Globus Medical Cranial Drill with Stop, 3.20mm [Ref: 6143.1842S]; 3) Globus Medical Cranial Drill, 6.00mm [Ref: 6143.1870S] |
|
| 07 Feb 2024 |
BioFire Diagnostics, LLC BIOFIRE FILMARRAY Pneumonia Panel and BIOFIRE FILMARRAY Pneumonia Panel plus |
|
| 07 Feb 2024 |
Applied Medical Resources Corporation (Sponsored by Applied Medical Australia Pty Ltd) Epix Universal Clip Applier |
|
| 07 Feb 2024 |
Arrow International LLC Subsidiary of Teleflex Incorporated (Sponsored by Teleflex Medical Australia Pty Ltd) Arrow QuickFlash Radial Artery Catheterisation Set |
|
| 07 Feb 2024 |
柯惠有限責任公司 Covidien llc 非吸收性聚酯縫線 Tricron Coated Braided Polyester Nonabsorbable Suture、非吸收性尼龍縫線 Surgilon Coated Braided Nylon Nonabsorbable Suture |
|
| 07 Feb 2024 |
邁道國際有限公司Medos International SARL 遠端輸送導管 Cerebase DA Guide Sheath |
|
| 06 Feb 2024 |
奧林巴斯醫療株式會社 電子十二指腸內窺鏡 |
|
| 06 Feb 2024 |
庫克公司Cook Incorporated 取石網籃 NGage Nitinol Stone Extractor |
|
| 05 Feb 2024 |
G & H Wire Company FLEXSelect 5/16" Amber Latex Elastics |
|
| 05 Feb 2024 |
MEDLINE INDUSTRIES, LP - Northfield MEDLINE ADULT BLOOD CULTURE KIT and other products |
|
| 05 Feb 2024 |
Vortex Surgical Inc. Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE |
|
| 05 Feb 2024 |
THOR Photomedicine Ltd NovoTHOR Whole Body Light Pod, Gen 3.0 |
|
| 05 Feb 2024 |
Barco N.V. Barco MDSC-8527 NXF |
|
| 05 Feb 2024 |
Alma Lasers Ltd. Alma TED |
|
| 05 Feb 2024 |
Cardinal Health 200, LLC Cardinal Health Monoject Syringes |
|
| 05 Feb 2024 |
Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps |
|
| 05 Feb 2024 |
Do Not Use Certain Cardinal Health Monoject Luer-Lock and Enteral Syringes –FDA Safety Communication |
|
| 05 Feb 2024 |
Thoratec Corp. HeartMate Touch Communication System |
|
| 05 Feb 2024 |
Olympus BICOAG Hemostasis Probes [Model: CD-B622LA; Lot No.: KR214212] |
|
| 05 Feb 2024 |
Butterfly Network Inc. Butterfly iQ+ Ultrasound System (USB-C) COO Taiwan [Model or catalog number: 900-20036-04; Multiple lot or serial numbers] |
|
| 05 Feb 2024 |
Voco Gmbh 1) Ionolux [Mutilple model or catalog numbers]; 2) Ionostar Plus [Mutilple model or catalog numbers] |
|
| 05 Feb 2024 |
Philips North America 1) Ingenia 1.5T (Product Number 781396); 2) Ingenia Elition X (Product Number 781358); 3) Ingenia Ambition X (Product Number 781356) |
|
| 02 Feb 2024 |
Olympus Corporation EZDilate Fixed Wire Balloon & EZDilate Wire Guided Balloon |
|
| 02 Feb 2024 |
TriMed Inc. Volar Bearing Plate |
|
| 02 Feb 2024 |
MICROVENTION INC. TERUMO HydroPearl Compressible Microspheres for Embolisation |
|
| 02 Feb 2024 |
Aesculap Inc JACOBSON DUROGRIP TC Micro Needle Holder, MILLS DUROGRIP TC Micro Needle Holder |
|
| 02 Feb 2024 |
AtriCure, Inc. Cryo Module Accessories Domestic CMA-OUS |
|
| 01 Feb 2024 |
Datex-Ohmeda, Inc. (GE HealthCare) EVair air compressor [Model numbers: M1230849 and M1230847; UDI/DI: 010084068210234621; Multiple Serial Numbers], EVair 03 (Jun-air) air compressor [Model numbers: 1609000 and 1609002; Multiple Serial Numbers], EvAir CPRSR Kit Upgrade [Model numbers: M1230849 and M12308471; Multiple Serial Numbers] |
|
| 01 Feb 2024 |
Abbott GmbH (Sponsored by Abbott Australasia Pty Ltd Diagnostic Division) The Alinity s System - IVD [List Number: 06P16-01; Multiple serial numbers] |
|
| 01 Feb 2024 |
XTANT Medical Holdings, Inc Cortera Spinal Fixation System [REF: 150100-85050; UDI-DI: 00810076564005; Lot number: AP23000143] - Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length |
|
| 01 Feb 2024 |
FX SHOULDER Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm [REF: 115-3210; UDI-DI: 03701037309551; Lot number: U0191] |
|
| 01 Feb 2024 |
"Siemens Healthcare Diagnostics Inc (Sponsored by Siemens Healthcare Pty Ltd) Atellica UAS 800 Urine Sediment Analyser & Atellica 1500 Automated Urinalysis System - IVD [Material Number: 11065004; UDI: 00630414001357; Software Version: All versions up to and including v4.0.400] ; " |
|
| 01 Feb 2024 |
Joerns Healthcare Ltd Oxford [Model: Mini, Midi, Major & Maxi] |
|
| 01 Feb 2024 |
Maquet Cardiovascular, LLC Recalls Atrium Express Dry Suction Dry Seal Chest Drain Containing Sterile Water Based Products Under Recall by Nurse Assist |
|
| 01 Feb 2024 |
Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error |
|
| 01 Feb 2024 |
Maquet Cardiopulmonary GmbH Bubble Sensor BS 3/8x3/32 L1.7 [Article no. 701055720; Affected Serial No.: 90041745 - 90042097 (274 pcs.)] |
|
| 01 Feb 2024 |
GBUK Banana Clip Sling [Multiple Product Codes and Lot Numbers] |
|
| 31 Jan 2024 |
RSR Ltd RSR LEM25 RiaRSR VGCC Ab Kit - Anti-human IgG |
|
| 31 Jan 2024 |
Arthrex Inc DX FiberTak Suture Anchor, ST & NDLs |
|
| 31 Jan 2024 |
Aidacare Pty Ltd Aspire FLX Bed |
|
| 31 Jan 2024 |
Philips Ultrasound, Inc. (Sponsored by Philips Electronics Australia Ltd) Philips EPIQ Series Ultrasound Systems |
|
| 29 Jan 2024 |
REM Systems Pty Ltd EQUASHIELD Closed System Transfer Device, Spike Tubing |
|
| 29 Jan 2024 |
W & H Australasia Pty Ltd Dental Surgical Handpieces without light |
|
| 29 Jan 2024 |
Excelsior Medical Llc Syringe, Sterile, Field Flush 10 Ml |
|
| 29 Jan 2024 |
Diasorin Inc. DiaSorin LIAISON HSV-2 Type Specific IgG |
|
| 29 Jan 2024 |
C.R. Bard Inc Bard Nasogastric Sump Tube, Bard Nasogastric Sump Tube , Bard PreVent Anti-Reflux Filter with ENFit, Bard Lopez Valve with ENFit, Bard Suction Connector with ENFit |
|
| 29 Jan 2024 |
American Contract Systems, Inc. Procedural convenience kits and trays |
|
| 29 Jan 2024 |
TERRAGENE S.A. Terragene Integron, Terragene Integron IT26-C with extender Benco Dental Chemical Integrator, Tuttnauer (WTL198-0082), Terragene Integron (PCD26-C) and Terragene Bionova PCD (PCD222-C) |
|
| 29 Jan 2024 |
KENT IMAGING, INC. Snapshot NIR |
|
| 29 Jan 2024 |
Philips Medical Systems Nederland B.V. (Philips North America) Achieva 1.5T, Achieva 1.5T Conversion, Achieva 3.0T, Ingenia Ambition X, Intera 1.5T, SmartPath to dStream for 1.5 |
|
| 26 Jan 2024 |
Maquet Critical Care AB Servo-n HFOV |
|
| 26 Jan 2024 |
Technopath Manufacturing Ltd (Sponsored by Abbott Australasia Pty Ltd Diagnostic Division) Technopath Multichem IA Plus, Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3 and Multichem P |
|
| 26 Jan 2024 |
Hazard Alert: Shoulder Modular Replacement Metal Back Liner (SMR MB L1 Liner) |
|
| 26 Jan 2024 |
瑞思邁私人有限公司 ResMed Pty Ltd 面罩及管路附件、面罩 Mask Air, oxygen、鼻面罩 Mask Air, oxygen |
|
| 26 Jan 2024 |
Medtronic Neuromodulation Model A710 Intellis Clinician Programmer Application, version 2.0.97 |
|
| 26 Jan 2024 |
Canadian Hospital Specialties Ltd. Doing Business As Chs Med-Rx P-Eggy Chest Drain Valve |
|
| 25 Jan 2024 |
Hologic, Inc. PANTHER FUSION System REF 912101000 |
|
| 25 Jan 2024 |
SEDECAL SA Sedecal X Optima URS digital mobile diagnostic x-ray system |
|
| 25 Jan 2024 |
Abbott GmbH (Sponsored by Abbott Australasia Pty Ltd Diagnostic Division) The Alinity s System - IVD |
|
| 25 Jan 2024 |
Abbott GmbH (Sponsored by Abbott Australasia Pty Ltd Diagnostic Division) The Alinity s System - IVD |
|
| 25 Jan 2024 |
Philips Medical Systems Nederland B.V. Spectral CT 7500 |
|
| 24 Jan 2024 |
Aligned Medical Solutions Convenience kits containing saline |
|
| 24 Jan 2024 |
邁柯唯心肺醫療有限責任公司 MAQUET Cardiopulmonary GmbH 血液濃縮器 |
|
| 24 Jan 2024 |
株式會社島津製作所 醫用血管造影X射線機 [涉及產品型號、規格: Trinias] |
|
| 24 Jan 2024 |
株式會社島津製作所 醫用血管造影X射線機 [涉及產品型號、規格: Trinias] |
|
| 24 Jan 2024 |
捷銳士股份有限公司 Gyrus ACMI, Inc. 一次使用雙極高頻手術器械 |
|
| 24 Jan 2024 |
深圳市愛立康醫療股份有限公司 臂式電子血壓計 |
|
| 24 Jan 2024 |
Lima Orthopaedics (Sponsored by Lima Orthopaedics Australia Pty Ltd) SMR MB L1 Liner |
|
| 24 Jan 2024 |
Medtronic Inc (Sponsored by Medtronic Australasia Pty Ltd) The Duet External Drainage and Monitoring System (EDMS) |
|
| 23 Jan 2024 |
INTEGRA PAIN MANAGEMENT Integra Cranial Access Kit, without drugs |
|
| 23 Jan 2024 |
HS Hospital Service AMICA GEN |
|
| 23 Jan 2024 |
FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-IPST |
|
| 23 Jan 2024 |
Eurosets S.r.l. EURIK180V INSERTION KIT-VENOUS; EURIK180VL INSERTION KIT-VENOUS LARGE; EURIK80A INSERTION KIT-ARTERIAL |
|
| 23 Jan 2024 |
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. DORC Directional Laser Probe |
|
| 23 Jan 2024 |
3M Deutschland GmbH 3M Surgical Clipper Blade Assembly and 3M Specialty Blade Assembly |
|
| 22 Jan 2024 |
Cardinal Health 200, LLC CardinalHealth Suction Canister Liner, MEDI-VAC CRD |
|
| 22 Jan 2024 |
Getinge Usa Sales Inc Maquet PowerLEDII OR Light System and Others |
|
| 22 Jan 2024 |
Samsung Electronics Co., Ltd. GM85 Digital Diagnostic Mobile X-Ray System |
|
| 22 Jan 2024 |
Randox Laboratories Ltd. Calibration Serum Level 3 CAL2351 |
|
| 22 Jan 2024 |
Randox Laboratories Ltd. Calibration Serum Level 3. CAL 3 |
|
| 22 Jan 2024 |
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292 |
|
| 22 Jan 2024 |
Thoratec Corporation HeartMate Touch Communication System |
|
| 22 Jan 2024 |
Southmedic Inc. Oxy2Mask |
|
| 22 Jan 2024 |
Abbott Laboratories (USA) (Sponsored by Abbott Australasia Pty Ltd Diagnostic Division) Alinity s System |
|
| 22 Jan 2024 |
Philips Medical Systems Nederland B.V. Philips Allura XPER, Allura Centron and Azurion Systems |
|
| 22 Jan 2024 |
Tornier, Inc Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V |
|
| 22 Jan 2024 |
Accure Acne, Inc Accure Laser System |
|
| 22 Jan 2024 |
Xcision Medical Systems, LLC GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System [Ref: XMSGP030A09.07-0.01] |
|
| 22 Jan 2024 |
Waldemar Link GmbH & Co. KG (Mfg Site) Link Patella Glide Resection Guide |
|
| 22 Jan 2024 |
Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, VITROS Immunodiagnostic Products Anti-HBs Calibrators |
|
| 22 Jan 2024 |
Randox Laboratories Ltd Calibration Serum Level 3 |
|
| 22 Jan 2024 |
Globus Medical, Inc. ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit [Part number 6203.2100; UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109] |
|
| 19 Jan 2024 |
PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID COVID-19 Rapid Antigen At-Home Test [REF: P0040; Lot: 22S0388-R01] |
|
| 19 Jan 2024 |
Steris Corporation V. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable, Overall Length 7 (18 cm)- Intended to cut through tape and bandages |
|
| 19 Jan 2024 |
Smiths Medical Asd Inc Multiple Products |
|
| 19 Jan 2024 |
Smiths Medical ASD, Inc. Medfusion Syringe Infusion Pumps |
|
| 19 Jan 2024 |
Covidien LLC McGRATH Mac 2 Laryngoscope Blade |
|
| 19 Jan 2024 |
Philips Medical Systems Nederland B.V. Philips Achieva, Intera and Ingenia Systems |
|
| 19 Jan 2024 |
ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices |
|
| 19 Jan 2024 |
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication |
|
| 19 Jan 2024 |
Maquet Cardiopulmonary GmbH Hemoconcentrator Set & Hemoconcentrator Set With Softline Coating |
|
| 19 Jan 2024 |
Caesarea Medical Electronics Ltd. Cardinal Health Monoject syringes |
|
| 19 Jan 2024 |
Aesculap AG Disposable Hasson Trocar 12/110mm |
|
| 19 Jan 2024 |
Cardinal Health Sofsilk Braided Silk Sutures |
|
| 19 Jan 2024 |
Percussionaire Corporation Distal Phasitron [Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit) |
|
| 19 Jan 2024 |
Percussionaire Corporation High Frequency Transport Phasitron Breathing Circuit Kit |
|
| 18 Jan 2024 |
Philips Medical Systems Nederland B.V. Azurion 7 M20 FlexArm system with Maquet Magnus Table |
|
| 18 Jan 2024 |
Johnson & Johnson Surgical Vision, Inc. TECNIS Toric II OptiBlue IOL Models ZCW |
|
| 17 Jan 2024 |
Stryker Scorpio, Duracon, PCA, Trident |
|
| 17 Jan 2024 |
邁柯唯心肺醫療有限責任公司 Maquet Cardiopulmonary GmbH 心肺輔助膜式氧合器;體外迴圈套包 |
|
| 17 Jan 2024 |
GE ULTRASOUND KOREA, Ltd. 與超聲診斷儀適配的超聲探頭 [涉及產品型號: IC9-RS; 相關的超聲診斷儀:VOLUSON S10 S10, VOLUSON S10 Expert; VOLUSON P6, VOLUSON P8, VOLUSON S6, VOLUSON S8; LPGIQ S8; VOLUSON SWIFT, VOLUSON SWIFT+; LOGIQ P7, LOGIQ P8, LOGIQ P9, LOGIQ P10 ] |
|
| 17 Jan 2024 |
Mölnlycke Procedure Trays: Emergency Chest Reopening Pack , ANZ Emergency Chest Re-opening Pack, Pack de Reesternotomia d’emergència, Specialset Thorax NKS, NZ Emergency Chest Re-opening Pack, Acute thorax tray, Emergency Chest Reopening Pack |
|
| 17 Jan 2024 |
Medline Drainage Bag reference DB1000 and Wound Drainage system reference SDS200B+DB1000 |
|
| 17 Jan 2024 |
Corcym S.r.l. Perceval Plus Suturless Aortic Heart Valve |
|
| 17 Jan 2024 |
LABORATOIRES URGO 法國優格公司 矽酮粘貼邊聚氨酯泡沫敷料 |
|
| 17 Jan 2024 |
Ansell Healthcare Europe NV (Ansell N.P.Sdn. Bhd., 安思爾 N.P. 有限公司) 一次性使用滅菌橡膠外科手套 |
|
| 17 Jan 2024 |
ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility |
|
| 17 Jan 2024 |
貝朗梅爾松根股份有限公司 B. Braun Melsungen AG 中心靜脈導管; 一次性使用中心靜脈導管包 (Certofix 和 ProSet Certofix) |
|
| 15 Jan 2024 |
Limacorporate S.p.A PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates |
|
| 15 Jan 2024 |
Sarnova HC, LLC Curaplex Field Cric Kit with ET Tube; Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm |
|
| 15 Jan 2024 |
Philips North America Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871 |
|
| 15 Jan 2024 |
ROi CPS LLC regard Operative LAP |
|
| 15 Jan 2024 |
Maquet Cardiovascular, LLC Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection ; Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit |
|
| 15 Jan 2024 |
Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 [Mutiple serial mumbers] |
|
| 15 Jan 2024 |
Philips Medical Systems Nederland B.V. 1) Ingenia Ambition X [Product Number 781356]; 2) Ingenia Ambition S [Product Number 781359] |
|
| 15 Jan 2024 |
Balt USA LLC Optima Coil System [Multiple model and lot numbers] |
|
| 15 Jan 2024 |
RRR Manufacturing Pty Ltd CellAED 2.2 |
|
| 15 Jan 2024 |
Ortho-Clinical Diagnostics, Inc. QMS Tacrolimus Calibrators |
|
| 15 Jan 2024 |
Oakworks Inc Ultrasound EA (Ergonomic Advantage) |
|
| 15 Jan 2024 |
Howmedica Osteonics Corporation HRIS Acet Cup Cut Tip 26x140 and HRIS Acet Cup Cut Tip 32x140 |
|
| 15 Jan 2024 |
GE Healthcare IITS USA Corp Centricity High Acuity Anesthesia and Centricity Anesthesia |
|
| 15 Jan 2024 |
Serf (Compliance Management Solutions) Disposable Cup Impactors (ICJ) packaged with NOVAE STICK 47 cemented dual mobility cups |
|
| 12 Jan 2024 |
Nipro Corporation (Sponsored by Nipro Australia Pty Ltd) Surefuser+ [Model Number: SFS-1002DP, SFS-1001DP, SFS-10-25PG, SFS-10-25PG, SFS-1.5-25P; Lot Number: 23H09P, 23H10P, 23H17P, 23H19P, 23H21P] |
|
| 12 Jan 2024 |
Covidien llc (Sponsored by Medtronic Australasia Pty Ltd) PM7100 INVOS Reusable Sensor Cables [Part Number: PMAC71RSC; Lot Number: 2023-05-04] |
|
| 12 Jan 2024 |
Maquet Cardiopulmonary GmBH (Sponsored by Getinge Australia Pty Ltd) RF-32#Centrifugal Pump with FLOWPROBE [Item number: 701005308; UDI: 4037691085364; Serial Number: 3000284766] |
|
| 12 Jan 2024 |
ResMed Ltd. Recalls Continuous Positive Airway Pressure (CPAP) Masks with Magnets due to Possible Magnetic Interference with Certain Medical Devices |
|
| 12 Jan 2024 |
Cosmedent, Inc. FlexiCups Medium Blue |
|
| 12 Jan 2024 |
Icotec Ag VADER pedicle system, torque wrench (Catalog Number 42-702) and VADER pedicle system, torque wrench (Catalog Number 42-703) |
|
| 12 Jan 2024 |
戈爾及同仁有限公司 W. L. Gore & Associates, Inc 人工血管 GORE PROPATEN Vascular Graft [涉及產品型號、規格: H470080W (原廠H470080系列對應型號)] |
|
| 12 Jan 2024 |
Canadian Hospital Specialties Ltd. Doing Business As Chs MED-RX Wound Management Kits and Catheter Trays |
|
| 12 Jan 2024 |
飛利浦醫療系統荷蘭有限公司 Philips Medical Systems Nederland B.V. 磁共振成像系統、醫用磁共振成像系統 [涉及產品的型號、規格: INTERA ACHIEVA 1.5T; ACHIEVA 3.0T; Intera 1.5T; Ingenia 3.0T CX] |
|
| 12 Jan 2024 |
Immunostics, Inc. Detector H. Pylori [Catalog Number: IHP-30] |
|
| 12 Jan 2024 |
愛德華茲生命科學有限責任公司 Edwards Lifesciences LLC 心臟瓣膜成形環 Annuloplasty Ring [涉及產品的型號: 5200;規格: 5200M24, 5200M26, 5200M28, 5200M30, 5200M32, 5200M34, 5200M36, 5200M38, 5200M40] |
|
| 11 Jan 2024 |
Beckman Coulter iQ200 Series Analyzers and DxU 850m and 840m Iris Analyzers |
|
| 11 Jan 2024 |
Getinge / Atrium Medical Corporation Issues Medical Device Correction for Nurse Assist Syringes Provided with Express Drains |
|
| 11 Jan 2024 |
Arcomed AG (Sponsored by Arcomed Pty Ltd) Syramed µSP6000 Chroma HYP with battery [Art. No. 6T-HYBA-01 + 6T-HYBA-W-BA] and Volumed µVP7000 Chroma HYP with battery [Art. No. 7T-HYBA-01 + 7T-HYBA-W-BA] |
|
| 11 Jan 2024 |
Abbott Laboratories 1) Alinity i Processing Module REF 03R65-01; 2) Alinity c Processing Module REF 03R67-01; 3) ARCHITECT c4000 Processing Module REF: 02P24-01, 02P24-02, 02P24-40, 01R24-56, 01R25-56 |
|
| 11 Jan 2024 |
GE HealthCare Potential Exposure to Certain Chemicals with Use of GE HealthCare EVair and EVair03 Compressors with Certain Ventilators – Letter to Health Care Providers |
|
| 10 Jan 2024 |
Thermo Fisher Scientific Urea |
|
| 10 Jan 2024 |
Waldemar Link GmbH & Co. KG Endo-Model System, Distal Femor.Spacer, Endo-Model RotationKnee Pr., UHMWPE,medium, left, 65 mm, Endo-Model System, Distal Femor.Spacer,Endo-Model RotationKnee Pr., UHMWPE,medium, right, 65 mm; |
|
| 10 Jan 2024 |
Greiner Bio One Gmbh Vacuette 4 Ml Fx Sodium Fluoride / Potassium Oxalate Tube] |
|
| 10 Jan 2024 |
Maquet Cardiopulmonary Gmbh Rotaflow Centrifugal Pump With Bioline |
|
| 09 Jan 2024 |
Insulet Corporation Recalls Omnipod 5 Android App due to a Software Error |
|
| 09 Jan 2024 |
Cardinal Health Medi-Vac CRD Suction Canister Liner 1L |
|
| 08 Jan 2024 |
ECOLAB Incidin OxyWipe S |
|
| 08 Jan 2024 |
Philips Medical Systems Nederland B.V. Azurion 7 System |
|
| 08 Jan 2024 |
Bio-Rad Medical Diagnostics GmbH Anti-D (Uppercase) I (Lowercase) A (Superscript) |
|
| 08 Jan 2024 |
Natus Medical Incorporated External Drainage System Collection Bag and EDS 3 CSF External Drainage System |
|
| 08 Jan 2024 |
Beaver Visitec International, Inc. Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807 |
|
| 08 Jan 2024 |
Townsend Design Custom made device dynamic ankle-foot orthosis (AFO) and Custom made device dynamic ankle-foot orthosis (KAFO) |
|
| 08 Jan 2024 |
Analytic Technology Corp (AngioDynamics) Pulse*Spray Infusion Systems 3fx135x120 |
|
| 08 Jan 2024 |
美國西門子醫學診斷股份有限公司 Siemens Healthcare Diagnostics Inc. 免疫球蛋白M測定試劑盒(免疫比濁法) |
|
| 08 Jan 2024 |
Insulet Corporation Omnipod 5 App |
|
| 08 Jan 2024 |
荷蘭飛利浦醫療系統公司 Philips Medical Systems Nederland B.V. 醫用磁共振成像系統、磁共振成像系統 Achieva 1.5T、Intera 1.5T |
|
| 08 Jan 2024 |
Philips Medical Systems Nederland B.V. 1) Brightview Gamma Camera System W/ 3/4" Cystal & Detector Caudal Cephalic Tilt; 2) Brightview Gamma Camera System W/ 3/8" Crystal And Detector Caudal Cephalic Tilt; 3) Brightview Gamma Camera System With 3/8" Crystal; 4) Brightview Gamma Camera With 3/4" Crystal; 5) Brightview XCT Imaging System - Tilt System |
|
| 08 Jan 2024 |
Exactech Australia Pty Ltd Equinoxe Reverse Shoulder Constrained Humeral Liner |
|
| 08 Jan 2024 |
DUBOIS CHEMICALS AUSTRALIA PTY LTD AntiBac San |
|
| 08 Jan 2024 |
Zimmer Biomet Spine Inc. Vitality Polyaxial Screw, 7.5mmx 50mm |
|
| 08 Jan 2024 |
Cordis US Corp MYNXGRIP 5F [REF MX5021] |
|
| 08 Jan 2024 |
Bard Peripheral Vascular Inc BD Recanalization System |
|
| 08 Jan 2024 |
Philips Healthcare (Suzhou) Co., Ltd. Incisive CT |
|
| 08 Jan 2024 |
Beaver Visitec International, Inc. Xstar Kojo Safety Slit Knife, 2.5mm 45, Bevel Up |
|
| 05 Jan 2024 |
Bio-Rad Laboratories Anti-Dia (DI1) [Catalog Number 808270; UDI 07611969951956; SRN DE-MF-000019864] |
|
| 05 Jan 2024 |
ROi CPS LLC Regard Dressing change kit [Item Number 800026006; UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270] |
|
| 05 Jan 2024 |
Keystone Industries KeySplint Hard Clear [Item No.: 4220011; UDI: UDI +H66842200111/$3251116NB3628L Lot No. NB3628] |
|
| 05 Jan 2024 |
Cordis Cashel (Sponsored by Cordis Australia Pty Ltd) Cordis OPTEASE Retrievable Vena Cava Filter and OPTEASE Retrieval Catheter [A) OPTEASE Retrievable Vena Cava Filter; Catalog Numbers: 466F210AF, 466F210AJ, 466F210BJ; B) OPTEASE Retrieval Catheter; Catalog Number:466C210F] |
|
| 05 Jan 2024 |
Gyrus ACMI, Inc SOLTIVE SuperPulsed Laser Ball Tip Fiber Single Use [Model or catalog number: TFL-FBX200BS; Lot or serial number: KR262848] |
|
| 05 Jan 2024 |
柯惠有限責任公司 Covidien llc 非吸收性尼龍縫線 Surgilon Coated Braided Nylon Nonabsorbable Suture [涉及產品的型號、規格: 88861919-71, 88861919-51] |
|
| 04 Jan 2024 |
Evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers |
|
| 04 Jan 2024 |
萬華普曼生物工程有限公司 促黃體生成素檢測試劑盒(膠體金免疫層析法) [涉及產品的型號、規格: 條型：1人份/袋，5袋/盒; 識別信息: 22080060] |
|
| 04 Jan 2024 |
Medline Industries, LP Left Heart SMGH-LF 2 [Model or Catalogue Number: DYNJ41932F; Lot or Serial Number: 23FBO002, 23FBR760, 23HBM924] |
|
| 04 Jan 2024 |
Canon Medical Systems Corporation Vantage Orian-Main Unit [Model or Catalog Number: MRT-1550/YX, MRT-1550/XD, MRT-1550/YP; Lot or Serial Number: All Lots] |
|
| 04 Jan 2024 |
Astoria-Pacific, Inc. Spotcheck - Neonatal Galt Microplate Reagent Kit [Model or Catalog Number: 81-4061-00K, 81-4000-60K; Lot or Serial Number: 231011, 230813] |
|
| 04 Jan 2024 |
Zimmer Biomet Dermacarriers II Skin Graft Carriers, 3:1 Ratio [Item Number: 00219501300, 00219501300; Lot Number: 65292843, 65390419] |
|
| 04 Jan 2024 |
Encore Medical, LP 1) Reverse Shoulder System e+ [REF: 509-01-032]; 2) All-Poly e + Patella, Domed Tri-Peg, 9x38mm [REF: 130-03-738] |
|
| 04 Jan 2024 |
Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication |
|
| 04 Jan 2024 |
Becton Dickinson Pty Ltd BD BBL Sensi-Disc [Multiple Product names, codes and lot numbers] |
|
| 04 Jan 2024 |
Beckman Coulter Australia Pty Ltd DxI 9000 Access Immunoassay Analyser [REF Number: 33410, C11137] |
|
| 03 Jan 2024 |
Cardinal Health Cardinal Health Presource Packs |
|
| 03 Jan 2024 |
Mirion Technologies (Capintec), Inc. Captus 4000e Thyroid Uptake System, all models |
|
| 02 Jan 2024 |
Atrium Medical Corporation Atrium Oasis Drain Single W / AC |
|
| 02 Jan 2024 |
韓國沃蘭牙科器械有限公司 WARANTEC CO., Ltd. 種植體螺絲起 |
|
| 02 Jan 2024 |
卡爾史托斯有限公司 KARL STORZ SE & Co. KG 鼻竇鏡無源器械Non-active Instruments for Sinoscopes;支氣管鏡無源器械Non-active Instruments for Bronchoscope;宮腔電切鏡及附件Endoscopes of Gynecology and Accessories;宮腔鏡無源器械Non-active Instruments for Endoscopes of Gynecology |
|
| 29 Dec 2023 |
邁柯唯心肺醫療有限責任公司Maquet Cardiopulmonary GmbH 心肺轉流熱交換水箱Heater-Cooler Unit [涉及產品型號、規格: HCU40; 序列號:90440220, 90440259, 90442336, 90442337, 90442299] |
|
| 29 Dec 2023 |
邁柯唯有限責任公司 MAQUET GmbH 醫用支撐腿架 Leg Holder [涉及產品型號、規格及批次: 100380A0; 序列號: 576、577、 578、579、580] |
|
| 29 Dec 2023 |
美敦力泌力美公司 Medtronic MiniMed 混合閉環胰島素輸注系統 [涉及產品型號、規格: MMT-1890; 序列號: NG3105252H 和 NG3401062H] |
|
| 29 Dec 2023 |
美國施樂輝有限公司 Smith & Nephew, Inc. 迷你萬向鎖定接骨板系統 EVOS Mini-Fragment Plating System [涉及產品型號、規格: 72402450N EVOS 2.4mm T7 星形頭皮質骨自攻螺釘，50mm(不銹鋼); 涉及批號：23FM12358, 醫療器械唯一標識：00885556446195] |
|
| 28 Dec 2023 |
MEDLINE INDUSTRIES, LP Tracheostomy Care and Cleaning Trays |
|
| 28 Dec 2023 |
B Braun Medical Limited LEONARD BUTTON EYELET WIRING TI (PAK10) [Product code: HS-075-01-W; Batch numbers: 58130373] |
|
| 28 Dec 2023 |
HSV-2 Tests for Genital Herpes Can Produce False Reactive Results - Letter to Clinical Laboratory Staff and Health Care Providers |
|
| 28 Dec 2023 |
Fresenius Medical Care Holdings, Inc. Liberty Select Cycler [Model numbers RTLR180343 and RTLR180111] |
|
| 28 Dec 2023 |
Landauer Landauer microSTARii reader [Model Numbers: 18000-000/18001-000/18007-000] |
|
| 28 Dec 2023 |
Lifeglobal Group Llc Global Medium [Model or catalog number: LGGG-050, LGGG-100, LGGG-020; Lot ot serial number: 231020-018742, 231020-018741, 231020-018743] |
|
| 28 Dec 2023 |
Gyrus Acmi, Inc TFL Fiber Cleaver and Stripper [Mutiple Model or catalogue number; All lots] |
|
| 28 Dec 2023 |
Siemens Healthcare GmbH ARTIS pheno, ARTIS icono biplane and ARTIS icono floor with VE OR Table |
|
| 28 Dec 2023 |
Occlutech GmbH Figulla Flex II ASD Procedure Pack [REF/ Art. No: 29ASD12F, 29ASD13F, 29ASD15F, 29ASD16F, 29ASD18F] |
|
| 28 Dec 2023 |
Philips Medical Systems Nederland B.V. Philips Azurion System R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2 |
|
| 28 Dec 2023 |
Cardinal Health Kangaroo Enteral Feeding Pump Sets |
|
| 28 Dec 2023 |
Steris Corporation Hookup Accessories used with MEDIVATORS ADVANTAGE PLUS and ADVANTAGE PLUS Pass Thru Automated Endoscope Reprocessors |
|
| 28 Dec 2023 |
Smiths Medical Medfusion Model 4000 and 3500 syringe infusion pumps [SKU/Model/Item: 3500E, 3010E; Affected Device Serial Numbers: M05377, M05179] |
|
| 28 Dec 2023 |
Samsung Electronics Digital Diagnostic Mobile X-ray System GM85 |
|
| 28 Dec 2023 |
Ortho Clinical Diagnostics (QuidelOrtho) VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators [Product Code (Unique Device Identifier): 1787753 (10758750006502); 1524693 (1075875000633); Affected Lot(s): 5051 5060 5070 5081 5090 5100; Expiry: 26-Dec-2023 13-Jan-2024 28-Jan-2024 06-Apr-2024 07-May-2024 04-Jun-2024] |
|
| 28 Dec 2023 |
OriGen Biomedical Accessory Sets Syringes RF-T15 and 15-RF60-T [Lot(s): V23276, V23277, V23278, V23639, V23281] |
|
| 28 Dec 2023 |
Löwenstein Medical SE & Co. KG Intensive Care Ventilators elisa 300, elisa 500, elisa 600, elisa 800 and elisa 800VIT with the following software versions: Software level 2.10.x – all software versions including 2.10.6 Software level 2.13.x – all software versions including 2.13.2 |
|
| 28 Dec 2023 |
Maquet Cardiopulmonary GmbH (MCP)/Getinge HLS Sets |
|
| 28 Dec 2023 |
Evolan Pharma AB Viscopaste PB7 [Device Model/Catalogue/part number(s): 4948; Affected serial or lot number range: D300381] |
|
| 28 Dec 2023 |
Philips Medical Systems Nederland B.V. Spectral CT 7500 (728333), Spectral CT 7500 China (728340), and Spectral CT on Rails (728334) |
|
| 27 Dec 2023 |
Steris Corporation Dual Articulating Head Rest |
|
| 27 Dec 2023 |
Philips Medical Systems Nederland B.V. Brightview Gamma Camera System with Crystal & Detector Caudal And Cephalic Tilt |
|
| 27 Dec 2023 |
Agilent Technologies Belgium Alissa Interpret |
|
| 27 Dec 2023 |
Philips Medical Systems (Cleveland), Inc 單光子發射計算機斷層掃描系統, 單光子發射及X射線電腦斷層成像系統 |
|
| 27 Dec 2023 |
生物梅里埃美國股份有限公司 bioMerieus, Inc 革蘭氏陰性細菌鑑定卡 |
|
| 27 Dec 2023 |
Zeus Scientific, Inc. ZEUS ELISA Parvovirus B19 IgG Test System and ZEUS ELISA Parvovirus B19 IgM Test System |
|
| 27 Dec 2023 |
Abbott Laboratories Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated |
|
| 27 Dec 2023 |
Vereinigte Papierwarenfabriken GmbH (VP) (Sponsored by Med-Con Pty Ltd) Stericlin Flat Roll 150mmx200m - 800304 |
|
| 22 Dec 2023 |
ResMed Notifies Customers About Updated Instructions and Labeling for Masks with Magnets Due to Potential Interference with Certain Medical Devices |
|
| 22 Dec 2023 |
AT-OS Srl (Sponsored by Device Technologies Australia Pty Ltd) DCA-70 / DCI-70 Drying Cabinets |
|
| 22 Dec 2023 |
Medline Industries, Lp Nurse Assist Products in Medline Surgical Kit |
|
| 22 Dec 2023 |
Howmedica Osteonics Corporation Scorpio and Duracon Total Knee Systems |
|
| 22 Dec 2023 |
Medline Industries, LP. Issues a Voluntary Nationwide Recall of Various Lots of Tracheostomy Care and Cleaning Trays |
|
| 22 Dec 2023 |
Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 [Mutiple serial mumbers] |
|
| 22 Dec 2023 |
BK Medical Australia Pty Ltd bkActiv 2300 Ultrasound Systems 2300-56 and 2300-66 [Multiple serial numbers] |
|
| 22 Dec 2023 |
MEDEX SECUFILL patient lines X50 [Product Code: SECU002; Batch Number: LX221001; Expiry date: 07/03/2025] |
|
| 21 Dec 2023 |
"Busse Hospital Disposals 1) Tracheostomy Care Tray – Sterile – Latex Free ; 2) Dressing Change Tray – Sterile – Latex Free ]; Tracheostomy Care Set – Sterile – Latex Free " |
|
| 21 Dec 2023 |
Aero Healthcare Aerowash Eyewash and Wound Irrigation Ampoules [Multiple batches] |
|
| 21 Dec 2023 |
郡是醫療株式會社 可吸收性敷料使用人工皮膚 [涉及產品的型號、規格及批次: PN-F40030, PN-F82060, PN-F82090, PN-F82120, PN-S40030;識別信息: 批號: 230224, 220702, 221207, 221208, 230224, 221106, 221204] |
|
| 21 Dec 2023 |
Beckman Coulter iQ200 Series Analyzers and DxU 850m and 840m Iris Analyzers; DxU 850m/840m Microscopy Analyzers; iQ200 Series Urine Microscopy Analyzers ; Rev 2 Flowcell Capsule Spare; iQ Waste Well Adapter |
|
| 21 Dec 2023 |
VBM Medizintechnik GmbH (Sponsored by Medtronic Australasia Pty Ltd) MANUJET III With Jet Vent Cath [Model: 30-01-003; Multiple Batch numbers] |
|
| 21 Dec 2023 |
Hologic Inc Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay [Product Code: PRD-07400 (ASY-16066)] |
|
| 21 Dec 2023 |
XVIVO Perfusion AB (Sponsored by Emergo Asia Pacific Pty Ltd T/a Emergo Australia) XVIVO Disposable Lung Circuit [Model Number: HQV89200] |
|
| 21 Dec 2023 |
BD Switzerland Sarl Alaris GH Plus Guardrails Syringe Pump [Model or Catalog Number: 8002MED01-G] |
|
| 21 Dec 2023 |
奧林巴斯醫療株式會社 電子支氣管內窺鏡 [涉及產品的型號、規格及批次: BF-1TQ290、BF-MP290F、BF-H290] |
|
| 21 Dec 2023 |
Covidien llc 可吸收釘修補固定器 [涉及産品的型号、規格: ABSTACK 15, ABSTACK 15V, ABSTACK 30, ABSTACK 30X] |
|
| 21 Dec 2023 |
Philips North America Llc CT x-ray system [System code: 728143 and 728144] |
|
| 21 Dec 2023 |
密西根重症監護顧問公司 MC3 Inc. 一次性使用膜式氧合器Nautilus ECMO Oxygenator [涉及産品的型号、規格: 48145, 48135] |
|
| 21 Dec 2023 |
碧迪醫療公司Becton Dickinson Medical（S）Pte.Ltd. 一次性使用無菌注射器帶/不帶注射針Hypodermic syringes with/without needle [涉及産品的型号、規格: Luer-Lok Tip BD 5ML Syringe; 識別信息: 2326052] |
|
| 21 Dec 2023 |
史賽克神經介入公司Stryker Neurovascular 微導管 [涉及産品的型号、規格: 90238, 90338] |
|
| 20 Dec 2023 |
Renishaw Mayfield SARL neuroinspire neurolocate [047.0107C/DE, 047.0107B/ES, 047.0107C/FR, 047.0107C/IT, 047.0107C/EN] |
|
| 20 Dec 2023 |
Molnlycke Healthcare UK 1) Neo Large Positioner with Cover 12x20 [Product number: 1400200-10; Batch numbers: 21429049, 21492545, 22026936, 22140658, 22488285, 23042291]; 2) Neo Medium Full Body Positioner with Cov [Product number: 1400206-10; Batch numbers: 21434862, 22376680, 23035977, 23012109]; 3) Neo Large Full Body Positioner with Cove [Product code: 1400213-02; Batch number: 18030013]; 4) Neo Small Tube Positioner with Disposabl [Product number: 1400222-02; Batch number: 19010002]; 5) Neo Large Tube Positioner with Cover 60 [Product number: 1400224-02; Batch number: 19070029] |
|
| 20 Dec 2023 |
Meru Bugzi [Serial numbers: E30001 to E30294] |
|
| 20 Dec 2023 |
Cardinal Health Dover™ 100% Silicone Foley Catheter [Multiple product codes; Multiple lot numbers] |
|
| 20 Dec 2023 |
For-De Group Pty Ltd Space Saver Shower Stool [SKU: RG554H2 – 4-Legged Shower Stool] |
|
| 19 Dec 2023 |
Olympus Single Use Distal Cover (MAJ-2315) |
|
| 18 Dec 2023 |
Olympus Single Use Distal Cover Model: MAJ-2315; All Lot Numbers |
|
| 18 Dec 2023 |
MEGADYNE MEGADYNE MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodess |
|
| 18 Dec 2023 |
Vero Biotech, LLC VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette |
|
| 18 Dec 2023 |
CHANGE HEALTHCARE CANADA COMPANY Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4 |
|
| 18 Dec 2023 |
CardioQuip, LLC 1) CardioQuip Modular Cooler-Heater |
|
| 18 Dec 2023 |
Inpeco S.A. Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD |
|
| 18 Dec 2023 |
APN Health LLC Navik 3D v2, [REF: NAVIK3D] |
|
| 18 Dec 2023 |
Olympus Corporation of the Americas ACMI Roller Bar Electrodes |
|
| 18 Dec 2023 |
Baxter Healthcare Corporation Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set |
|
| 18 Dec 2023 |
C.R. Bard Inc Sensica Urine Output System |
|
| 18 Dec 2023 |
Abbott Ireland Diagnostics Division Alinity i HBsAg Reagent Kit |
|
| 18 Dec 2023 |
Recall: Logiwash and Legency Remedies Sodium Chloride 0.9% ampoules |
|
| 18 Dec 2023 |
Legency Remedies Private LOGIWASH Sodium Chloride for Irrigation 0.9% ALL batches ( 2386053E & 2386054E); Expiry Date: 03/2028 |
|
| 18 Dec 2023 |
Integra LifeSciences Corp. CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P |
|
| 18 Dec 2023 |
Q-Med AB (Sponsored by Galderma Australia Pty Ltd) Sculptra Poly L Lactic Acid Vials 150mg Powder for Injection |
|
| 18 Dec 2023 |
AusDiagnostics Pty Ltd Low RNA Reagent Cassette; 40331 [Lot Numbers: C297749RL, C297192RL; Expiry date: 19-Sep-2024, 12-Sep-2024] |
|
| 18 Dec 2023 |
Phadia AB (Sponsored by Abacus dx Pty Ltd) ImmunoCAP Rare Allergen k220, Allergen component rHev b 6.02 Latex |
|
| 18 Dec 2023 |
Atrium Medical Corporation (Sponsored by Getinge Australia Pty Ltd) Sterile Water Syringe supplied with Atrium Express Dry Suction Dry Seal Chest Drain |
|
| 18 Dec 2023 |
Maquet Critical Care AB (Sponsored by Getinge Australia Pty Ltd) Flow Family Anesthesia systems |
|
| 18 Dec 2023 |
廣州市康燭醫療器械有限公司 中頻脈沖治療儀 |
|
| 18 Dec 2023 |
廣東名立醫療科技有限公司 一次性使用醫用口罩 |
|
| 15 Dec 2023 |
Resmed Pty Limited Airtouch and Airfit ResMed Masks |
|
| 15 Dec 2023 |
Welch Allyn Inc Q-Stress and X-Scribe Cardiac Stress Testing Systems Version 6 or higher |
|
| 15 Dec 2023 |
Wallac Oy (Sponsored by Revvity Pty Ltd) NeoBase 2 Non-derivatized MSMS kit |
|
| 15 Dec 2023 |
Philips Medical Systems Nederland B.V. Azurion Systems with software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 |
|
| 14 Dec 2023 |
Abbott Automation Solutions GmbH GLP systems Track |
|
| 14 Dec 2023 |
MEDLINE INDUSTRIES, LP - Northfield Multiple Products |
|
| 14 Dec 2023 |
Trudell Healthcare Solutions Inc. Trudell Sterile Water |
|
| 14 Dec 2023 |
Encore Medical, LP RSP Glenoid Baseplate, 30mm P2 Porous Coated |
|
| 13 Dec 2023 |
Roche Potential false negative Influenza A H1N1 Results with select Roche assays used on the cobas 5800/6800/8800 systems |
|
| 13 Dec 2023 |
The Insides Company The Insides Driver (Driver) |
|
| 13 Dec 2023 |
Medtronic Limited NIM TriVantage EMG Endotracheal Tube Model Numbers 8229706, 8229707, 8229708, 8229736, 8229737, and 8229738 |
|
| 13 Dec 2023 |
VOSTRA GmbH Rhinotamp and Rhinotamp latexfrei |
|
| 13 Dec 2023 |
Swemac Innovation AB, Sweden Radius PE Cup Ø15mm |
|
| 13 Dec 2023 |
Karl Storz SE& Co. KG Multiple Products |
|
| 13 Dec 2023 |
Integra Lifesciences Production Corporation The CODMAN VPV SYSTEM |
|
| 13 Dec 2023 |
BD CME/BD BodyGuard Infusion Pump Systems |
|
| 13 Dec 2023 |
Amity Ltd Virusolve+ Concentrate and Virusolve+ Ready To Use |
|
| 13 Dec 2023 |
以色列通用電氣醫療影像系統有限公司 GE Medical systems Israel, Functional Imaging 單光子發射斷層掃描裝置;單光子發射斷層及X射線電腦體層攝影成像系統; 單光子發射及X射線電腦斷層成像系統 Discovery NM 630, Discovery NM/CT 670 Pro, Discovery NM/CT 670 CZT |
|
| 13 Dec 2023 |
奧森多臨床診斷(英國)有限責任公司 Ortho Clinical Diagnostics (QuidelOrtho) 乙型肝炎病毒表面抗體檢測試劑盒（化學發光法） |
|
| 13 Dec 2023 |
羅氏診斷公司 Roche Diagnostics GmbH 活化部分凝血活酶時間檢測試劑盒(凝固法) aPTT Screen; aPTT; aPTT Lupus |
|
| 13 Dec 2023 |
徠卡生物系統（紐卡斯爾）有限公司 脫臘液 BOND Dewax Solution |
|
| 13 Dec 2023 |
太平洋醫材股份有限公司 抽痰包 [涉及產品的型號、規格及批次: 型號:I21012, 規格: 4.00mm(12Fr)x460mm; 批次: 403310; 識別資訊: 22012748] |
|
| 13 Dec 2023 |
北京朋來製藥有限公司 醫用防護口罩 |
|
| 13 Dec 2023 |
Bio-Rad (Sponsored by Bio-Rad Laboratories Pty Ltd) Monolisa HCV Ag/Ab ULTRA V2 |
|
| 13 Dec 2023 |
Gyrus Acmi Inc (Sponsored by Olympus Australia Pty Ltd) Paparella-Type Vent Tube - 240044 |
|
| 12 Dec 2023 |
GALLINI S. R. L. 穿刺活檢針 |
|
| 11 Dec 2023 |
Encore Medical, LP DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED; DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L |
|
| 11 Dec 2023 |
Medtronic Inc. Medtronic SynchroMed |
|
| 11 Dec 2023 |
Bebig Isotopentechnik Gmbh SagiPlan 2.2, CE0344, Rx Only |
|
| 11 Dec 2023 |
Riverpoint Medical, LLC Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) |
|
| 11 Dec 2023 |
Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive |
|
| 11 Dec 2023 |
Maquet Medical Systems USA CARDIOHELP Emergency Drive Part Numbers 701048002 and 701076205 |
|
| 11 Dec 2023 |
Meridian Bioscience Inc Para-Pak Clean Vial; Para-Pak Zn-PVA/10% Formalin; Cardinal Health Clean Stool Transportation System |
|
| 11 Dec 2023 |
Limacorporate S.p.A PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 |
|
| 11 Dec 2023 |
Liberty Medical Solutions, LLC Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation |
|
| 11 Dec 2023 |
BioReference Health, LLC The 4Kscore Test |
|
| 08 Dec 2023 |
Gyrus ACMI, Inc. SOLTIVE Laser System |
|
| 08 Dec 2023 |
Randox Laboratories Ltd. RANDOX Total Bilirubin |
|
| 08 Dec 2023 |
Luminex Corporation Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018 |
|
| 08 Dec 2023 |
Stanbio Laboratory, LP STAT-Site M BHB Test Strips |
|
| 08 Dec 2023 |
CooperSurgical, Inc. H/S ELLIPTOSPHERE CATH 5 Fr; H/S ELLIPTOSPHERE CATH 5 FR Set; H/S CATHETER SET FR 5 with Integated Stylet |
|
| 08 Dec 2023 |
Canadian Hospital Specialties Ltd. Doing Business As CHS Med-RX I.V. Set Stopcock |
|
| 07 Dec 2023 |
Remington Medical, Inc. Remington MEDICAL Drainage Bag |
|
| 07 Dec 2023 |
Hologic, Inc. Aptima CMV Quant Assay |
|
| 07 Dec 2023 |
Stryker Spine LITe Decompression Tube Snake Arm |
|
| 07 Dec 2023 |
Nurse Assist, LLC Multiple Products |
|
| 07 Dec 2023 |
Medtronic Navigation, Inc. Sterile Percutaneous Reference Pin |
|
| 07 Dec 2023 |
Vyaire Medical vyaire Flexible Patient Circuit |
|
| 07 Dec 2023 |
Abiomed Europe GmbH Impella Introducer Kits |
|
| 06 Dec 2023 |
史派克公司 Spectranetics Corporation 一次性使用鐳射光纖導管CLiRpath Turbo & Turbo elite Excimer Laser Ablation Catheters |
|
| 06 Dec 2023 |
Maquet Cardiovascular, LLC /Getinge VasoView HemoPro Endoscopic Vessel Harvesting |
|
| 06 Dec 2023 |
碧迪公司Becton, Dickinson and Company 預充式導管沖洗器 BD Pre-filled Flush Syringes |
|
| 06 Dec 2023 |
蔚藍紐帶科技有限公司Blue Belt Technologies, Inc. 膝關節置換手術導航系統 Surgical Navigation System |
|
| 06 Dec 2023 |
奧林巴斯醫療株式會社 纖維鼻咽喉內窺鏡、電子膀胱腎盂內窺鏡、電子膀胱腎盂鏡、纖維膀胱腎盂鏡 |
|
| 05 Dec 2023 |
B. Braun Melsungen AG Combitrans / Combidyn Monitoring Sets |
|
| 05 Dec 2023 |
Thermo Fisher Scientific Mueller Hinton + Horse Blood + NAD (4MM) |
|
| 05 Dec 2023 |
Siemens Healthineers Sensis; Sensis Bibe Hemo; Sensis Vibe Combo |
|
| 05 Dec 2023 |
Philips Trilogy Evo and Trilogy Evo O2 Ventilators |
|
| 05 Dec 2023 |
Össur Power Knee Battery |
|
| 05 Dec 2023 |
Exactech, Inc. Exactech Knee, Hip, Shoulder and Ankle polyethylene products |
|
| 05 Dec 2023 |
Cook Incorporated Tuohy-Borst Adapter |
|
| 05 Dec 2023 |
BALT Extrusion SAS FARGO and CRISTAL BALLOON (CBV) |
|
| 05 Dec 2023 |
B. Braun Melsungen AG Combitrans / Combidyn Monitoring Sets |
|
| 05 Dec 2023 |
Baxter Healthcare Corporation Amia Automated PD Set With Cassette |
|
| 05 Dec 2023 |
Cardinal Health Webril Undercast Padding |
|
| 04 Dec 2023 |
B. Braun Medical, Inc. Infusomat Administration Sets |
|
| 04 Dec 2023 |
Legency Remedies Private (Sponsored by Interpharma Pty Ltd) Sodium Chloride 0.9% 30ml plastic ampoules |
|
| 04 Dec 2023 |
Atrium Medical Corporation Atrium Firm PVC Thoracic Catheter 36FR Straight |
|
| 04 Dec 2023 |
Abiomed, Inc Automated Impella Controller (AIC) |
|
| 04 Dec 2023 |
CardioQuip, LLC CardioQuip Modular Cooler-Heater |
|
| 04 Dec 2023 |
Boston Scientific Corporation Zoom Programming System |
|
| 04 Dec 2023 |
Thor Photomedicine Ltd Multiple Products |
|
| 04 Dec 2023 |
Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal Chest Drain |
|
| 04 Dec 2023 |
AURIS HEALTH INC Monarch Platform |
|
| 04 Dec 2023 |
Stryker Medical Division of Stryker Corporation ProCurity bed series |
|
| 04 Dec 2023 |
Staar Surgical Company Multiple Products |
|
| 04 Dec 2023 |
Elekta, Inc. Multiple Products |
|
| 04 Dec 2023 |
Carestream Health, Inc. DRX Revolution Mobile X-Ray System |
|
| 04 Dec 2023 |
Smiths Medical Asd, Inc. Multiple Products |
|
| 04 Dec 2023 |
Canon Medical Systems Corporation Vantage Galan 3T |
|
| 04 Dec 2023 |
Baxter Healthcare (Sponsored by Welch Allyn Australia Pty Limited) E-Scibe |
|
| 04 Dec 2023 |
Randox Laboratories Ltd COPPER (Cu) |
|
| 04 Dec 2023 |
Baxter Healthcare SA Hemostatic Products |
|
| 04 Dec 2023 |
Synovis Life Technologies, Inc. A Subsidiary Of Baxter International Inc Synovis Intravascular Probes, Shunts and Patches |
|
| 01 Dec 2023 |
Recall: Interpharma Sodium Chloride 0.9% 30mL ampoules |
|
| 01 Dec 2023 |
Aizu Olympus Co., Ltd. EVIS EXERA III COLONOVIDEOSCOPE, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE |
|
| 01 Dec 2023 |
EMD Millipore Corporation Lugol s Iodine Solution 500ML |
|
| 01 Dec 2023 |
Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication |
|
| 01 Dec 2023 |
Unauthorized blood glucose (sugar)-reading smartwatches may pose serious health risks to people with diabetes |
|
| 01 Dec 2023 |
William A Cook Australia Pty Ltd MINC+ Benchtop Incubator |
|
| 30 Nov 2023 |
Boston Scientific INGENIO, VITALIO, and ADVANTIO dual chamber (DR) extended life (EL) pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps) |
|
| 30 Nov 2023 |
Actim Oy PROM and Partus products |
|
| 30 Nov 2023 |
Breas Medical, Inc. with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc |
|
| 30 Nov 2023 |
Intuitive Surgical, Inc. Da Vinci Single-Site Wristed Needle Driver |
|
| 30 Nov 2023 |
Nouvag AG Dispenser DP 30 |
|
| 30 Nov 2023 |
Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men - Letter to Health Care Providers |
|
| 30 Nov 2023 |
Promedics Orthopaedics Ltd Elastic Wrist/Thumb Brace products [Lot Number: 075213, 077370, 077903, 077990, 078102, 078448] |
|
| 30 Nov 2023 |
nal von minden GmbH NADAL Strep A Test |
|
| 30 Nov 2023 |
Drägerwerk AG & Co. KGaA Anesthesia Workstation Atlan |
|
| 29 Nov 2023 |
Potential contamination of some saline products with Ralstonia pickettii |
|
| 29 Nov 2023 |
Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating: FDA Safety Communication |
|
| 29 Nov 2023 |
Intuitive Surgical Inc da Vinci X/Xi SureForm 45 |
|
| 29 Nov 2023 |
Advanced Sterilization Products, Inc. STERRAD 100NX Sterilizers and STERRAD NX Sterilizers |
|
| 29 Nov 2023 |
Schiller Medical DEFIGARD Touch-7 |
|
| 29 Nov 2023 |
Medical Precision BV (Sponsored by Gamma Gurus Pty Ltd) Comfort Marker 2.0 Safety Needle used with the Medical Precision Comfort Marker 2.0 Patient Marking System |
|
| 29 Nov 2023 |
Leica Biosystems Nussloch Gmbh Histocore Pegasus |
|
| 29 Nov 2023 |
Maquet Cardiopulmonary Gmbh A) Heart Lung Perfusion Pack With Softline; B) Perfusion Set With Bioline Coating |
|
| 28 Nov 2023 |
Unomedical A/S Recalls VariSoft Infusion Sets Due to Damage to the Connector Piece Causing Unexpected Disconnections |
|
| 28 Nov 2023 |
Integra Pain Management Cranial Access Kit |
|
| 28 Nov 2023 |
Exocad Gmbh Exoplan |
|
| 28 Nov 2023 |
ITL Asia Pacific Sdn Bhd (Sponsored by ITL Australia Pty Ltd) Intravenous Cannula Insertion Pack |
|
| 28 Nov 2023 |
Acute Innovations LLC (Sponsored by Medical & Optical Instruments Australia Pty Ltd) Low Profile Primary Guide |
|
| 28 Nov 2023 |
Dentsply Sirona Pty Ltd Atlantis Abutment in Ti - Straumann Bone Level 3.3 NC |
|
| 27 Nov 2023 |
奧林巴斯醫療株式會社 電子腹腔內窺鏡 [涉及產品的型號、規格及批次: LTF-S190-5; LTF-S190-10] |
|
| 27 Nov 2023 |
bioMérieux VIDAS CK-MB [Reference Number: 30421; Lot Number/Serial Number/ Product version: 1009900940; Product Expiration Date (if applicable): 25-Jan-2024] |
|
| 27 Nov 2023 |
Atricure, Inc. Atricure Cryo Module Accessories [Model or catalogue number: CMA-US; Lot or serial number: 131614, 129674] |
|
| 27 Nov 2023 |
Ortho-Clinical Diagnostics Inc. Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide) [Model or catalogue number: 826 2396; Lot or serial number: 5732-3598- 4651, 5732-3598-4650] |
|
| 27 Nov 2023 |
Becton Dickinson Infusion Therapy Systems Inc. BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533 [UDI-DI: 00382903825332, Lot: 3166524, Expiration: 2026/05/31] |
|
| 27 Nov 2023 |
PATH (PATH MEDICAL GmbH) A) SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098 [UDI-DI: 04260223142437; Serial Numbers: 201015-201029]; B) SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2 [UDI-DI: 04260223145377; Serial Numbers: 290402-290403, 290405-290408, 290422-290433, 290435-290443, 29044]; C) AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP [UDI-DI: 04260223143298; Serial Numbers: 260446-260468]; D) SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S [UDI-DI: 04260223142475; Serial Numbers: 280117] |
|
| 27 Nov 2023 |
廣東同德藥業有限公司 一次性使用醫用口罩 [生産批號: 221106; 涉及産品的型號、規格及批次: 耳掛式 (17.5cm x 9.5cm)] |
|
| 27 Nov 2023 |
Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel: potential risk of infection |
|
| 27 Nov 2023 |
Philips Medical Systems Nederland B.V. Business Unit Magnetic Resonance-site Best 醫用磁共振成像系統 [涉及產品型號、規格: Panorama HFO; 識別資訊（如批號）: 37067, 37149, 37188] |
|
| 24 Nov 2023 |
Philips Achieva 1.5T MRI System [Product: 781296; Serial Numbers: 32306 and 33117] |
|
| 24 Nov 2023 |
Smiths Medical Asd, Inc. Pump, Medfusion, Model 4000 [Model or catalogue number: 4000-0101-249, 4000-0101-50, 4000-0105-51, 4000-0601-01, 4000-0106-00, 4000-0100-50, 4000-0101-51, 4000-0100-249] |
|
| 24 Nov 2023 |
Smiths Medical Asd, Inc. 1) Medfusion Syringe Infusion Pumps [Model or catalogue number: 3500VX-500, 3500VX-415, 3500, 3500-415, 3500-306, 3500-414, 3500-500, 3500SD, 3500VX, 3500BC, 3500VX-306]; 2) Pharmguard Toolbox Version 1.5 [Model or catalogue number: 22-3510-51] |
|
| 24 Nov 2023 |
Schiller Medical Defigard Touch7 Monitor And Defibrillator [Model or Catalogue Number: 1-128-9900; All Lots] |
|
| 24 Nov 2023 |
Bd Switzerland Sarl Bd Smartsite Low Sorbing Extension Set [Model or Catalogue Number: 10013902] |
|
| 23 Nov 2023 |
Getinge 701048012 CARDIOHELP-i and 701072780 CARDIOHELP-i (US-Version) with the parts venous probe 701048804 (accessory) + 701069333 (spare part) |
|
| 23 Nov 2023 |
Getinge 701048012 Cardiohelp-i; 701072780 Cardiohelp-i [All Serial Numbers] |
|
| 23 Nov 2023 |
Instrumentation Laboratory 1) GEM Premier 3000 PAK - pH, pCO2, pO2, Hct [Part Numbers: 00024307504, 00024330004, 00024345004]; 2) GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++ [Part Numbers: 00024307507, 00024315007, 00024330007, 00024345007, 00024360007]; 3) GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate [Part Numbers: 00024315009, 00024330009, 00024345009, 00024360009] |
|
| 23 Nov 2023 |
Ortho Clinical Diagnostics ORTHO BioVue Cassettes [Affected Products ORTHO Blood Grouping Reagents: Ortho BioVue System Reverse Diluent (ABD/Reverse Cassette), Ortho BioVue System Control (Rh/K Cassette), Ortho BioVue System Control (Rh/K II Cassette), Ortho BioVue System Anti-Human Globulin Anti-IgG-C3d; polyspecific Neutral Solution (Poly/ Neutral Cassette), Ortho BioVue System Control Reverse Diluent (ABO-Rh/Reverse Grouping Cassette); Product Code (Unique Device Identifier): 6986736 (10758750032112), 707250/707280 (10758750008117) (10758750008087), 6986735 (10758750031634), 707310/707355 (10758750008148), (10758750008179); 707100/707155 (10758750007943) (10758750008049); Affected Lot(s): ABF056F, RHP123J, RHK049J, PLN079F, ABR390F; Expiry: 01-Sep-2023. 06-Sep-2023, 30-Sep-2023, 02-Oct-2023] |
|
| 23 Nov 2023 |
Mo-vis Scoot Control [Device Model/Catalogue/part number(s): P015-61 Scoot Control R-net, P015-65 Scoot Control R-net Bundle, P015-66 Scoot Control R-net Bundle Short, P015-71 Scoot Control LiNX, P015-75 Scoot Control LiNX Bundle, P015-76 Scoot Control Bundle Short, P015-51 Scoot Control Throttle R Assembly, P015-52 Scoot Control Throttle L Assembly, P015-53 Scoot Control Throttle Set; Unique Device Identifier(s) (UDI-DI): 05407008320119, 05407008320126, 05407008320817, 05407008320867, 05407008321000, 05407008321017; Affected serial or lot number range: All production units from 2023: Scoot Controls R-net (P015-61/65/66): 3114, 3148-3154 and 3170-4385; Scoot Controls LiNX (P015-71/75/76): 1000-1024; Scoot Control Throttle Sets (P015-51/52/53): PO1997] |
|
| 23 Nov 2023 |
Medtronic Guardian 4 Sensor [Manufacturer's Product Number/Catalog Number: MMT-7040C1, MMT-7040C2 , MMT-7040C3, MMT-7040QC, MMT-7040D1, MMT-7040D2 ; Multiple LOT Numbers] |
|
| 23 Nov 2023 |
Medtronic Guardian 4 Sensor [Manufacturer's Product Number/Catalog Number: MMT-7040C1, MMT-7040C2 , MMT-7040C3, MMT-7040QC, MMT-7040D1, MMT-7040D2 ; Multiple LOT Numbers] |
|
| 23 Nov 2023 |
Kirchner & Wilhelm GmbH + Co. KG SwiSto3 {lontophoresis device) [Model: Surface electrodes with sponge pockets, Spare sponge pockets, alone; Ref: 05.19080.001, 05.19090.001] |
|
| 23 Nov 2023 |
Cepheid Xpert Xpress CoV-2/Flu/RSV plus [Single Registration Number (SRN): US-MF-000010979; Unique Device Part Number Identifier (UDI): 07332940008000; Part Number: XP3COV2/FLU/RSV-10; All batch number, lot number] |
|
| 23 Nov 2023 |
Actim Actim Partus Test [Catalogue Number: 31931ETAL, 31930ETAL; All Lot numbers] |
|
| 23 Nov 2023 |
ACON Biotech (Hangzhou) Co., Ltd. ACON FLOWFLEX SARS-CoV-2 [Lot Numbers with confirmed issue: COV2095027, COV2075016, COV2105020, COV2105014, COV2105020, COV2105021, COV2105024, COV2105049; Lot numbers with suspected issue: COV2105042, COV2105002, COV2105006, COV2105009, COV2105010, COV2105023, COV2105033, COV2105034, COV2105043, COV2105050, COV2105051, COV2105055, COV2105057, COV2105058, COV2115019, COV3025001, COV3025013; Device Model/Catalogue/part number(s): 1 Packs and 5 Packs] |
|
| 23 Nov 2023 |
LEONI CIA CABLE SYSTEMS ORION System with software OSS v6.0 and OSS v7.0 [Part Number: 1SOPT00003 [UDI-DI: (01)03700383510017 SN: 100000001141] |
|
| 23 Nov 2023 |
Avanos Medical, Inc. AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, [Product code 221038; UDI/DI 00609038945064, Lot Numbers: 30112716, 30122936, 30116495, 30122179, 30116496, 30124942, 30117487, 30126227, 30117488, 30124946, 30117632, 30127429, 30117633, 30127494, 30113925, 30137504, 30119101, 30153170, 30119102, 30151042, 30116223, 30194152, 30123991] |
|
| 23 Nov 2023 |
Medtronic Neuromodulation Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators [UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N; UDI/DI 00763000724436, Serial Numbers: NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N] |
|
| 23 Nov 2023 |
Roche Diagnostics Operations, Inc. Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503) [All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)] |
|
| 23 Nov 2023 |
Physio-Control, Inc. LIFEPAK 15 AC Power Adapter [Model or Catalog Number: 11140-000098] |
|
| 23 Nov 2023 |
SunMed Holdings, LLC A) Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations; B) Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations; C) Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations; D) Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations; E) Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations; F) Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations; G) Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations; H) Curaplex manual resuscitators with integrated manometer, multiple accessory configurations; I) Medline manual resuscitators with integrated manometer, multiple accessory configurations |
|
| 23 Nov 2023 |
Sage Products Inc stryker Sage PrimaFit External Urine Management System for the Female Anatomy [GTIN 00618029600417, Lot Codes: 93667, 93614, 93613] |
|
| 23 Nov 2023 |
Ambu A/S (Sponsored by AMBU Australia Pty Ltd) Ambu aView 2 Advance [Catalogue Number: 405011000, 405011000AUS1, 405011000AUS2; All versions and lot numbers] |
|
| 23 Nov 2023 |
Randox Australia Pty Ltd RX Daytona Plus (with ISE & without ISE) [Catalogue Number: RX4040, RX4041] |
|
| 23 Nov 2023 |
BioFire Diagnostics, LLC FilmArray TORCH [Model/Part Number: HTFA-ASY-0104; UDI-DI Code: 00815381020253; Serial Numbers: All serial numbers] |
|
| 22 Nov 2023 |
Resmed Pty Ltd Resmed Masks with Magnets |
|
| 22 Nov 2023 |
Resmed Pty Ltd ResMed Masks with Magnets [AirFit N10, AirFit N10 for Her, AirFit N20, AirFit N20 for Her, AirTouch N20, AirTouch N20 for Her, AirFit F20, AirFit F20 for Her, AirTouch F20, AirTouch F20 for Her, AirFit F30, AirFit F30i; All lot numbers] |
|
| 22 Nov 2023 |
深圳市先亞生物科技有限公司 紅細胞壽命測定呼氣試驗儀 [涉及產品型號、規格：III型采氣用具；識別資訊 （如批號）：2023090601] |
|
| 22 Nov 2023 |
Voluntary Recall of SoClean Equipment Intended for Use with CPAP Devices and Accessories: FDA Safety Communication |
|
| 22 Nov 2023 |
Utak Laboratories Inc UTAK Validity Control 2 and 3, UTAK Validity Control 2, UTAK Validity Control 3[Lot Number: C8933, D1950, 10445226; Unique Device Identification (UDI): 00630414974750C893320231130, 00630414974750D195020240930, 00630414979984D182120240831; Expiry Date: 30/11/2023, 31/08/2024, 30/09/2024] |
|
| 22 Nov 2023 |
Becton Dickinson and Company BD BACTEC Micro MGIT Calibration Vial [Lot Number: 2209320, 2067938; Catalogue Number: 441049] |
|
| 22 Nov 2023 |
Ardo medical AG Master Vacuum Pumps [Model or catalog number: 30.00.30, 30.00.35, 17-8689; Lot or serial number: 2315316, 2315317] |
|
| 21 Nov 2023 |
Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps |
|
| 21 Nov 2023 |
B. Braun Medical Inc. Infusomat Space Pump IV Set with Anti-Siphon Valve [Products: Infusomat Space Pump Burette IV Set With Anti-Siphon Valve, Infusomat Space Pump IV Set With Anti-Siphon Valve, Infusomat Space Pump Low Adsorption IV Set With Anti-Siphon Valve, Infusomat Space Pump Y-Type Blood IV Set With Anti-Siphon Valve; Model or catalog number: 363032, 363422, 363901, 363433, 363420, 363424, 363904, 363421, 363423, 363430, 363410, 363902, 363419; Lot numbers lower than 0061902124] |
|
| 21 Nov 2023 |
Abbott Rapid Diagnostics Pty Ltd ID NOW Instrument. An in vitro diagnostic medical device (IVD) [Part Number: NAT-000, NAT-000S; All serial numbers] |
|
| 20 Nov 2023 |
ROi CPS LLC Regard CV PK [ Item Numbers a) 880289014, b) 880289015] |
|
| 20 Nov 2023 |
PB Medical Pty Ltd METRAN JPAP Travel CPAP Machines [Serial Numbers: P1808E00428 to JP1808E00447] |
|
| 20 Nov 2023 |
Randox Australia Pty Ltd 1) Calibration Serum Level 3; 2) Human Assayed Multi-Sera Level 2 and Level 3 |
|
| 20 Nov 2023 |
Groupe Sebbin FatWasher 800 [Device model: Reference LS 08 001; Affected batch: N010306] |
|
| 20 Nov 2023 |
JRI Orthopaedics Ltd. SECURUS Distal Locking Screw 30mm [Catalogue Reference: 110-00-30; Lot Number: 119820; UDI-DI / GTIN; 05032982029088] |
|
| 20 Nov 2023 |
Integra Lifesciences Production Corporation Codman Cranial Hand Drill [UDI: 10381780514961; Catalog Number: 826607; Lot number: 6563961, 6568711, 6568709, 6568710] |
|
| 20 Nov 2023 |
Feather Safety Razor Co., Ltd., Japan Micro Feather Disposablle Ophthalmic Scalpel With Plastic Handle [Device Model/Catalogue/Part Number(s): P-700 (REF 200200700), P-715 (REF 200200715), P-722 (REF 200200722), P-730 (REF 200200730), P-745 (REF 200200745) and USP-745 (REF 200500745); Type / REF: P-700 / 200200700, P-715 / 200200715, P-722 / 200200722, P-730 / 200200730, P-745 / 200200745, USP-745 / 200500745; Multiple Lot] |
|
| 20 Nov 2023 |
E & O Laboratories Ltd Saline with Beads [Unique Device Identifier(s) (UDI-DI): 5060484111321; Device Model/Catalogue/part number(s): BM0385; Affected serial or lot number range: 04104324, 04104343, 04104558] |
|
| 20 Nov 2023 |
Arthrex GmbH Disposable Cerclage Tensioner [Part No. AR-7820; Lot No.: 3039129043; UDI: 00888867373976] |
|
| 20 Nov 2023 |
Abbott Alinity m HCV AMP Kit [List Number: 08N50-090; LotNumbers:383203,385720,381581,382447; Unique Device Identifiers (UDis): ( 01)00884999047648( 10 )383203(17 )241230(240 )o8N 50-090 ( 01)0088499904 7648(10 )385720( 17)250226(240 )o8N 50-090 (01)00884999047648(10)381581(17)241006(240)08N50-090 (01)00884999047648(10)382447(17)241111(240)08N50-090] |
|
| 20 Nov 2023 |
力康華耀生物科技（上海）有限公司 肌電生物回饋儀 [涉及產品型號、規格：HF3000；識別資訊 （如批號）：HF0802810002] |
|
| 20 Nov 2023 |
上海樂合生物科技有限公司 特異性生長因數測定試劑盒（化學法）[涉及產品型號，規格：50mL (R1 40mL x 1, R2 10mL x 1)，校準品：2mL x 1，質控品：1mL x 1；批號：20230210] |
|
| 20 Nov 2023 |
上海樂合生物科技有限公司 小而密低密度脂蛋白膽固醇測定試劑盒（直接清除法）[涉及產品型號，規格：40mL (R1 30mL x 1, R2 10mL x1) 120 mL (R1 45mL x 2, R2 30mL x1)校準品：1mL x 1質控品1: 1mL x 1質控品2: 1mL x 1；批號：20230407] |
|
| 20 Nov 2023 |
MicroPort Orthopedics Inc.微創骨科股份有限公司 人工膝關節系統 [涉及產品的型號、規格: ETPKN4SL; 批次: MP1966173] |
|
| 20 Nov 2023 |
瑞士捷邁公司 Zimmer GmbH 髖關節假體-陶瓷股骨頭和襯墊 Hip Joint Prostheses-Ceramic Femoral Head and Liner [產品編號: 00-8777-040-01 (批號: 3145299); 00-8777-040-02(批號: 3145300)] |
|
| 20 Nov 2023 |
奧林巴斯醫療株式會社 攝像頭、內窺鏡攝像系統、內窺鏡用攝像頭、內窺鏡攝像裝置 [涉及產品的型號、規格: CH-S190-XZ-E, CH-SI90-XZ-Q, CH-S200-XZ-EA, CH-S200-XZ-EB CH-S400-XZ-EA, CH-S400-XZ-EB, CH-SC2-ID, OTV-S7H-IN, OTV-S7H-1D, OTV-S7PROH-HD-10E, OTV-S7PROH-HD-10Q, OTV-S7PROH-HD-12E, OTV-S7PROH-HD-12Q] |
|
| 20 Nov 2023 |
美國施樂輝有限公司 Smith & Nephew, Inc. 迷你萬向鎖定接骨板系統 [涉及產品的型號、規格: 72402712N EVOS 2.7mm T8 星形頭皮質自攻螺釘，(不銹鋼); 涉及批號:21FM19250，醫療器械唯一標識: 00885556449691] |
|
| 20 Nov 2023 |
美敦力公司 Medtronic Inc. 程式控制充電套件 [涉及產品的型號、規格:97745; 批次:NLDl 72060N;NLD142952N;NL D172064N;NLD142947N;NLD1 42942N;NLD172061N;NLD172 062N;NLD172063N;NLD17206 6N;NLD160337N;NLD163006N ;NLD142943N;NLD163007N;N LD142944N;NLD163008N;NLD 160338N;NLD163009N;NLD16 0339N;NLD163010N;NLD1603 40N;NLD163011N;NLD163003 N;NLD163012N;NLD163004N; NLD163013N;NLD163005N] |
|
| 20 Nov 2023 |
MEDLINE INDUSTRIES, LP - Northfield A) ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 [UDI/DI 40889942604723 (case), 10889942604722 (unit): Lot Numbers: 23EMI373, 23EMF712, 23DMF155, 23CMH026]; B) PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561 [UDI/DI 40193489402811 (case), 10193489402810 (unit): Lot Numbers: 23EMF711, 23CMH027]; C) CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562 [UDI/DI 40193489402446 (case), 10193489402445 (unit): Lot Numbers: 23DMF156, 23CMH030, 23CMD955]; D) 24 BLOOD CULTURE KIT, REF DYNDH1632 [UDI/DI 40193489916141 (case), 10193489916140 (unit): Lot Numbers: 23EMF710, 23DMF154, 23DMA779]; E) BLOOD CULTURE KIT, REF DYNDH1647B [UDI/DI 40195327267002 (case), 10195327267001 (unit): Lot Numbers: 23CMH028, 23CMD954] |
|
| 20 Nov 2023 |
Philips North America Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 [UDI-DI: 00884838103627; Lot Code: 1005] |
|
| 20 Nov 2023 |
Musculoskeletal Transplant Foundation, Inc. DBX Demineralized Bone Matrix Putty 10cc [Model Number: 038100; GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025] |
|
| 17 Nov 2023 |
Philips Medical Systems Nederland B.V. Ingenuity CT & Brilliance CT 64 with software version 4.1.7 |
|
| 17 Nov 2023 |
Asensus Surgical Inc. Senhance Surgical System |
|
| 17 Nov 2023 |
Microbiologics Inc 1) KWIKSTIK, P. venetum [Catalog numbers: 0794P (2-pack), 0794K (6-pack)]; 2) LYFO-DISK, P. venetum [Catalog number: 0794L] |
|
| 17 Nov 2023 |
Pulse Oximeter Accuracy and Limitations: FDA Safety Communication |
|
| 17 Nov 2023 |
Maquet Cardiopulmonary GmBH CARDIOHELP System [Multiple serial numbers] |
|
| 17 Nov 2023 |
Philips North America Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 [UDI-DI: 00884838103627; Lot Code: 1005] |
|
| 17 Nov 2023 |
Covidien llc (Sponsored by Cardinal Health Australia 503 Pty Ltd) Kangaroo Enteral Feeding Pump Sets: Kangaroo Joey Pump Set 1000 mL [Product Code: 666106-]; Kangaroo Joey ENPlus Spike Set [Product Code: 777501]; Kangaroo Joey ENPlus 3-in-1 Set [Product code: 777503]; Kangaroo Pump Set 1000 mL EZ Bag [Product code: 777106] (All product manufactured from April 2022 with lot numbers 22D to July 2023 to lot numbers 23G) |
|
| 17 Nov 2023 |
Respironics Inc DreamStation Auto CPAP - Care Orchestrator [AUX500S15; Serial number: J32217410F40C] |
|
| 16 Nov 2023 |
ResMed Ltd. ResMed Masks with Magnets [AirFit N10, AirFit N10 for Her, AirFit N20, AirFit N20 for Her, AirTouch N20, AirTouch N20 for Her, AirFit, F20, AirFit F20 for Her, AirFit F20 NV, AirTouch F20, AirTouch F20 for Her, AirFit F30, AirFit F30i] |
|
| 16 Nov 2023 |
Kilitch Healthcare India Limited Lubricant Eye Drops & Multi-Symptom Eye Drops |
|
| 16 Nov 2023 |
美國FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection (Update) |
|
| 16 Nov 2023 |
Physio-Control, Inc. A) LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 [UDI: 00883873988022/ Serial number: 38370274]; B) LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 [UDI: 00883873979426/ Serial number: 38290540 38291328 38315311 38315314 38324196 38324199 38332345 38898631]; C) LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 [UDI: 00883873979358/ Serial number: 38166543]; D) LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 [UDI: 00883873911648/ Serial number: 40644322 40644323 40644331 42221204 42934131]; E) LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 [UDI: 00883873884331/ Serial number: 49618486]; F) LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 [UDI: 00883873871713/ Serial number: 44174756, 46013280, 46966395, 48149013]; G) LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 [UDI: 00883873871706/ Serial number: 46687975]; H) LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 [UDI: 00883873871690/ Serial number: 43393466 44142362 44739628 44742060 47821623 49025144 49663485 49887344]; I) LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 [UDI: 00883873871683/ Serial number: 48839976]; J) LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 [UDI: 00883873871669/ Serial number: 48433670 and 48744028] |
|
| 16 Nov 2023 |
Bard Peripheral Vascular, Inc. Bard Mission Disposable Core Biopsy Instrument and Kit [Catalogue numbers: 1410MSK, 1416MSK, 1610MSK, 1616MSK, 1810MSK, 1816MSK, 1820MSK, 1825MSK, 2010MSK, 2016MSK, 2020MSK; Multiple lot numbers] |
|
| 16 Nov 2023 |
Thorasys Thoracic Medical Systems Inc C2 Airwave Oscillometry System [Lot numbers: 142467, 142468, 142469, 142470, 142471, 142472, 142473, 142474, 142475, 142476, 14247, 142478, 142479, 142480, 142481, 142482] |
|
| 16 Nov 2023 |
Siemens Medical Solutions USA, Inc Mobilett Mira wireless (VA20) mobile x-ray system(s) [Model Number: 10273100; UDI: 04056869009117; Serial: 1511 2168 2525 2633] |
|
| 16 Nov 2023 |
Ion Beam Applications S.A. PROTEUS 235 [PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0.] |
|
| 15 Nov 2023 |
Maquet Cardiopulmonary GmbH 701048012 CARDIOHELP-i and 701072780 CARDIOHELP-i (US-Version) with the parts venous probe 701048804 (accessory) + 701069333 (spare part) |
|
| 15 Nov 2023 |
Nobel Biocare AB IPS CaseDesigner Software [IPS CaseDesigner 2.2 for Windows 64-bit; IPS CaseDesigner 2.2 for MAC; IPS CaseDesigner 2.3 for Windows 64-bit; IPS CaseDesigner 2.3 for MAC] |
|
| 15 Nov 2023 |
Siemens Healthcare Diagnostics Inc RAPIDPoint 500 and 500e Systems Measurement Cartridges (with lactate) [Material numbers: 10491447, 10491448, 10491449; Unique Device Identifiers (UDI): 00630414589756, 00630414589763, 00630414589770] |
|
| 15 Nov 2023 |
深圳市理邦精密儀器股份有限公司 生物刺激反饋儀 [涉及産品的型号、規格及批次: Q3、 Q6、 Q9、 Q10、 Q12] |
|
| 15 Nov 2023 |
Ypsomed Australia Pty Ltd CamAPS FX and mylife CamAPS [Product code: 64648] |
|
| 15 Nov 2023 |
Philips Electronics Australia Ltd HeartStart Intrepid Monitor/Defibrillator [Product code: 867172] |
|
| 14 Nov 2023 |
廣州醒目醫藥科技有限公司 碘伏棉球 [涉及產品的型號、規格及批次: DFMQ-2 25球/瓶; 批號:22110802] |
|
| 13 Nov 2023 |
Siemens Healthcare GmbH 1) 數字化X射線攝影透視系統; 2) 數字化泌尿X射線系統; 3) 數字化X射線攝影透視系統 [涉及產品規格、型號: Luminos Agile Max; Uroskop Omnia Max; Luminos dRF Max] |
|
| 13 Nov 2023 |
Randox Australia Pty Ltd Serology ToRCH IgM Positive Control (IVD) [Catalogue number: SR10349; Lot number: 157SR; Expiry: 28/05/2024] |
|
| 13 Nov 2023 |
Jeisus Medical Inc. 傑希思醫療公司 Nd:TAG Laser surgery equipment Nd:YAG激光治療儀 [涉及產品規格、型號: TRI-BEAM; 識別信息: TPID22048] |
|
| 13 Nov 2023 |
Fujifilm Corporation 富士膠片株式會社 1) 血氨質控品; 2) 多項目低值質控品; 3)多項目高值質控品; 4) 電解質質控品; 5) C-反應蛋白測定試劑盒（速率法） |
|
| 13 Nov 2023 |
Diamed GmbH 達亞美有限責任公司 全自動血型分析儀 [涉及產品規格、型號: IH-500] |
|
| 13 Nov 2023 |
Young Dental Manufacturing I, LLC CONTRA GRAY (soft) TURBO PLUS CUPS [REF: 153112; UDI/DI: 10302731631127; Lot Number: 223466] |
|
| 13 Nov 2023 |
Becton, Dickinson And Company BD Biosciences BD CD11b APC, CE [Model or catalog number: 333143; Lot or serial number: 3114710] |
|
| 13 Nov 2023 |
Medtronic Navigation, Inc. StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software & StealthStation FlexENT System, with StealthStation ENT software |
|
| 13 Nov 2023 |
飛利浦醫療系統硏發和製造中心有限公司 數字化醫用X射線攝影系統、透視攝影X射線機 [涉及產品的型號、規格及批次: ProxiDiagnost N90 (10001031, 20000185, 20000186, 20000187, 20000188) 及 DigitalDiagnost C90 (23860515, 23860514)] |
|
| 13 Nov 2023 |
Siemens Healthcare GmbH ARTIS icono biplane, ARTIS icono floor and Artis pheno with Large Display [Product codes: 11327600, 11327700, 10849000] |
|
| 13 Nov 2023 |
奧森多臨床診斷(美國) 有限公司 二氧化碳測定試劑盒（幹化學酶法）檢測盒 [涉及產品的型號、規格及批次: 批次 5732-3598-5102] |
|
| 13 Nov 2023 |
奧林巴斯醫療株式會社 一次性內窺鏡超聲吸引活檢針 [涉及產品的型號、規格及批次: NA-201SX-4022; 33K, 34K, 35K, 36K, 37K] |
|
| 13 Nov 2023 |
Ortho-Clinical Diagnostics Inc. VITROS Chemistry Products CKMB Slides [Model or Catalogue Number: 800 1133, 805 8232; All Lots] |
|
| 13 Nov 2023 |
Baxter Healthcare Corporation Novum IQ Syringe infusion system, [Product Code 40800BAXUS; All Serial Numbers] |
|
| 13 Nov 2023 |
Cordis US Corp Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter [UDI/DI 10705032025935, Lot Number 18223410] |
|
| 10 Nov 2023 |
BD Switzerland Sarl BD Infusion Sets |
|
| 10 Nov 2023 |
Philips Medical Systems DMC GmbH CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system [Model No. 709030 and 709031]; DigitalDiagnost 4 Chest/Emergency [Model No. 712029 & 712033]; DigitalDiagnost 4 Flex/Value [Model No. 712028, 712227, & 712032]; DigitalDiagnost 4 High Performance [Model No. 712027, 712031 & 712226]; DigitalDiagnost C90 Flex/Value/Chest/ER [Model No. 712035]; DigitalDiagnost C90 High Performance [Model No. 712034]; DigitalDiagnost C90 Release 3 [Model No. 712025]; DigitalDiagnost C90 Release 3.1 [Model No. 712026]; EasyDiagnost Eleva DRF, Release 5 [Model No. 706050]; ProxiDiagnost N90 [Model No. 706100 & 706110] |
|
| 10 Nov 2023 |
Encore Medical, LP 1) RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus [Ref.: 509-03-432]; 2) RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm [Ref.: 509-01-436] |
|
| 10 Nov 2023 |
Becton, Dickinson and Company (BD) 1) Phasix Mesh; 2) Phasix ST Mesh; 3) Phasix Plug and Patch; 4) Phasix ST Mesh with Open Positioning System (OPS); 5) Phasix ST Mesh with Echo 2 Positioning System; 6) GalaFLEX Lite Scaffold; 7) GalaFLEX Scaffold; 8) GalaFLEX 3D Scaffold; 9) GalaFLEX 3DR Scaffold |
|
| 10 Nov 2023 |
Breas Medical Ab NIV Angled Mouthpiece with Notch 22F/15F [Model or catalog number: 006093; Lot or serial number: 32305269, 32304444, 32306017] |
|
| 09 Nov 2023 |
Philips Allura and Azurion systems [Product Description: Poly G - OMCP - VISUB - CCD (H5000), Allura Xper FD10C, Allura Xper FD10 , Allura Xper FD20, Allura Xper FD10, Allura Xper FD20, Allura Xper FD20 OR Table, Integris H5000 C / Allura 9C, Integris Allura 9, Allura Xper FD10 OR Table, Allura Xper FD20 OR Table, Allura Xper FD10, Allura Xper FD20, Allura Xper FD10 OR Table, Allura Xper FD20 OR Table, Integris Allura 15 & 12 (monoplane), Azurion 7 M12, Azurion 7 M20, Azurion 7 M12, Azurion 7 M20, Azurion 5 M12, Azurion 5 M20; Product Code: 72246, 722001, 722003, 722006, 722010, 722012, 722015, 722016, 722018, 722022, 722023, 722026, 722028, 722033, 722035, 722043, 722078, 722079, 722223, 722224, 722227, 722228] |
|
| 09 Nov 2023 |
Canon Medical Systems Corporation Alphenix INFX-8000v - Main Unit [Model or Catalogue Number: INFX-8000V/PV; Lot or Serial Number: PVD2292001] |
|
| 09 Nov 2023 |
Macopharma Poches À Sang Quadruple [Model or Catalogue Number: LQT710X; Lot or Serial Number: 11487575BM] |
|
| 09 Nov 2023 |
Baxter Healthcare Corporation Novum Iq Large Volume Pump Novum Iq Large Volume Pump [Model or Catalogue Number: 40700BAX] (Re: Unapproved Adhesive) |
|
| 09 Nov 2023 |
Baxter Healthcare Corporation Novum Iq Large Volume Pump [Model or Catalogue Number: 40700BAX; All Lots] (Re: Operator's Manual) |
|
| 09 Nov 2023 |
Encore Medical, LP DJO EMPOWR Knee Punch Handle [REF: 801-05-040; UDI-DI: 00190446238881; Multiple Lots] |
|
| 09 Nov 2023 |
Percussionaire Corporation Monitron II Waveform Analyzer [REF: S00015-1; UDI-DI: 00849436000068; Multiple Serial Numbers] |
|
| 09 Nov 2023 |
Pulmonx, Corp. Zephyr Endobronchial Valve (EBV) 5.5-LP [REF: EBV-TS-5.5-LP; UDI: (01)00811907030423(10)506590V70(17)241208; Lot: 506590-V7.0] |
|
| 09 Nov 2023 |
Alcon Research, LLC Alcon Custom-Pak, Surgical Procedure Pack [REF 14057-09; Lot: 160NMU; UDI: (01)10380653302278] |
|
| 09 Nov 2023 |
Alphatec Australia Pty Ltd oneFIT TOTAL KNEE PSI [Lot numbers: 230638, 230675, 230710, 230711, 230732, 230745, 230823, 230859, 230877, 231021, 231046] |
|
| 09 Nov 2023 |
Getinge Australia Pty Ltd ACROBAT-i Vacuum Positioner System [Product code: XP-5000Z; Multiple lot numbers] |
|
| 09 Nov 2023 |
Merit Medical Australia Pty Ltd Merit Maestro Microcatheter [Product code: 28MC24150ST/F; Lot Number: H2749681] |
|
| 08 Nov 2023 |
Maquet Cardiopulmonary GmBH The CARDIOHELP-i System [Product code: 701048012; All serial numbers] |
|
| 08 Nov 2023 |
Temptime Corporation Safe-T-Vue 10 [Model or Catalogue Number: TT-7201-50; Lot or Serial Number: S10061923] |
|
| 08 Nov 2023 |
Baxter Healthcare Corporation Novum Iq Large Volume Pump [Model or Catalogue Number: 40700BAX] |
|
| 08 Nov 2023 |
B. Braun Medical Inc. Infusomat Administration Sets [Model or catalogue number: 362033, 362035, 362050, 362432, 362911, 363032, 363410, 363419, 363420, 363421, 363422, 363423, 363424, 363430, 363433, 363901, 363902, 363904, 470119, 490037, 490038, 490100, 490101, 490102, 490103, 490104, 490105; Lot or serial number: More than 10 numbers] |
|
| 08 Nov 2023 |
Olympus Australia Pty Ltd EZDilate Fixed Wire Balloon [Multiple product codes] |
|
| 08 Nov 2023 |
"Elekta Solutions Ab 1) Elekta Infinity [Model or catalogue number: XRT1501, XRT1511]; 2) Elekta Synergy [Model or catalogue number: XRT1412, XRT1402]; 3) Versa Hd [Model or catalogue number: XRT 20319, XRT 20419]" |
|
| 07 Nov 2023 |
Getinge 701048012 Cardiohelp-i; 701072780 Cardiohelp-i [All Serial Numbers] |
|
| 07 Nov 2023 |
Instrumentation Laboratory Co. 1) Gem Premier 3500 System-Iqm Bg/Hct Pak; 2) Gem Premier 3500 System-Iqm Bg/Lytes; 3) Gem Premier 4000 System-Pak Ph, Pco2, Hct, Thb, O2hb, Cohb, Methb; 4) Gem Premier 4000 System-Pak Ph, Pco2, Po2, Na+, K+, Ca++, Cl-, Glu, Thb; 5) Gem Premier 4000 System-Pak Ph, Pco2, Po2, Na+, K+, Ca++, Cl-, Hct, Thb; 6) Gem Premier 5000-Pak Ph, Pco2 ; 7) Gem Premier 5000-Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; 8) Gem Premier 5000-Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2; 9) Gem Premier 5000-Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 |
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| 07 Nov 2023 |
Masimo Corporation Rainbow Adhesive Sensors [Model or Catalogue Number: 2219, 2221, 2222; Lot or Serial Number: 22FTG, 22FTD, 22FTE] |
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| 07 Nov 2023 |
Maquet SAS/Getinge OR Light Systems |
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| 07 Nov 2023 |
Teleflex, and Arrow International, Recall Pressure Injectable Catheter Kits for Mislabeling |
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| 07 Nov 2023 |
Nurse Assist, LLC Issues Recall of 0.9% Sodium Chloride Irrigation USP and Sterile Water for Irrigation USP Nationwide and to Canada |
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| 07 Nov 2023 |
Do Not Use Certain Brands of Saline and Sterile Water Medical Products by Nurse Assist Because They May Not Be Sterile: FDA Safety Communication |
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| 06 Nov 2023 |
Magellan Diagnostics, Inc. LeadCare II Blood Lead Test Kit |
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| 06 Nov 2023 |
Baxter Healthcare Corporation HILLROM PROGRESSA+ BED |
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| 06 Nov 2023 |
Abbott Abbott NT2000iX Radiofrequency (RF) generator [REF: RFG-NT-2000] |
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| 06 Nov 2023 |
Corin Ltd 1) Unity CR Femur Right, Size 6 [Model Number: 112.001.32]; 2) Unity Total Knee System [Model Number: 112.001.34] |
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| 06 Nov 2023 |
bioMérieux BIOFIRE FILMARRAY TORCH System [Part No.: HTFA-ASY-0104; Shipping Configuration No.: HTFA-ASY-0001; All Serial Numbers] |
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| 06 Nov 2023 |
Cytocell Ltd Cytocell 20pter Subtelomere Specific Probe. An in vitro diagnostic medical device (IVD) [Lot number: 086784] |
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| 06 Nov 2023 |
東莞市華力醫療科技有限公司 醫用電子體溫計 [涉及產品規格、型號: HL-T10; 生產批次：T221210; 生產批號：1221210] |
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| 06 Nov 2023 |
Securitas Healthcare LLC Arial Water Resistant Pendant with Neck Lanyard, Arial Water Resistant Pendant with Wristband, Arial Water Resistant Pendant with Long Wristband [Models: 59360, 2560-59360, 59361, 2560-59361, 59362, 2560-59362; Manufacturing date codes: 23128 to 23251, 23128 to 23251, 23128 to 23251] |
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| 06 Nov 2023 |
Medtronic Neuromodulation LEAD 3387S-40 STIMLOC DBS [Model Number: 3387S-40; UDI/DI 00763000274320; Serial Number VA2JV2V] |
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| 06 Nov 2023 |
Cepheid A) Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only [UDI: (01)07332940006372/ Lots: 23718 23719 23720 10309 23201 23305 23308 23312 23314 23315 23401 23402 23403 23404 23405 23406 23407 23501 23504 23505 23506 23408 23410 23510 23411 23604 23605 23607 23608 23609 23610 23611 23612 23701 23702 23703 23705 23706 23707 23708 23709 23710 23711 23712 23714 23716 23717 23113 23316 23912 24112 23820 24704 24302 24307 24507 24508 24511 23822 23823 23824 24512 24513 24514 23825 24313 24515 24516 24517 24805]; B) Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, UDI: (01)07332940006297/ Lot: 23815 |
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| 06 Nov 2023 |
Breg Inc BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS [Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223] |
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| 06 Nov 2023 |
B. Braun Medical, Inc. A) FT1000S FLUID TRANSFER SET, REF No. 356048 [UDI-DI: 4022495769558 Lots 0061755752, 0061761812, 0061766279]; B) SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121 [UDI-DI: 4046964183454 Lots 0061746019 0061755023]; C) AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191 [UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409]; D) 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950 [UDI-DI: N/A Lots 0061766049]; E) TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070 [UDI-DI: N/A Lots 0061753485]; F) THERASPHERE ADMIN SET, Article No. 7M2650 [UDI-DI: 5060116920635 Lot 0061790166]; G) ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804 [UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770]; H) 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970 [UDI-DI: N/A Lots 0061742253 0061751732]; I) BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN [UDI-DI: N/A Lot 0061744741, 0061749486] |
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| 06 Nov 2023 |
Cosmedent, Inc. Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx. [Lot numbers 464948, 465769, 467512, 470596, 477493, 478610, 479776, 482382, 484262, and 484781; UDI-DI D77940310111] |
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| 03 Nov 2023 |
Getinge 1) CARDIOHELP-i (Mat. 701048012); 2) CARDIOHELP-i (US Variant) (Mat. 701072780) |
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| 03 Nov 2023 |
RAYSEARCH LABORATORIES AB RayCare 5B and 6A including service packs |
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| 03 Nov 2023 |
Medtronic Australasia Pty Ltd LINQ II Insertable Cardiac Monitoring Systems (LNQ22) |
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| 03 Nov 2023 |
Covidien McGrath Mac 2, Disposable Laryngoscope Blade, Sterile EO, Rx Only [REF: 350-017-000, 350-084-000; UDI: 10884521816336, 10884521824386; Lot # 22082207, 22083101, 22102001] |
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| 03 Nov 2023 |
Change Healthcare Canada Company Change Healthcare Radiology Solutions [Model or catalog number: 72008731 VERSION 14.X] |
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| 02 Nov 2023 |
永豐化學工業股份有限公司 "永豐"生理食鹽水注射液SODIUM CHLORIDE INJECTION "Y.F." |
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| 02 Nov 2023 |
Cardinal Health, Inc 1) LEADER Eye Irritation Relief (Polyvinyl Alcohol, 0.5%, Povidone, 0.6%, and Tetrahydrozoline Hydrochloride, 0.05%); 2) LEADER Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 3) LEADER Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 4) LEADER Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 5) LEADER Dry Eye Relief (Polyethylene Glycol 400, 0.4% and Propylene Glycol, 0.3%); 6) LEADER Lubricant Eye Drops (Propylene Glycol, 0.6%) |
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| 02 Nov 2023 |
The Harvard Drug Group, LLC 1) Rugby Polyvinyl Alcohol, 1.4% Lubricating Eye Drops; 2) Rugby Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) |
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| 02 Nov 2023 |
Philips Achieva 1.5T, Achieva 1.5T Conversion, Ingenia 1.5T CX, Intera 1.5T, Intera 1.5T Power/Pulsar, SmartPath to dStream for 1.5T [Product Number (REF): 781105, 781195, 781295, 781178, 781196, 781296, 781343, 781283, 781346, 781261, 781262, 781260, 782112; Multiple Serial Numbers] |
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| 02 Nov 2023 |
bioMérieux BIOFIRE Blood Culture Identification 2 (BCID2) Panel [Reference Number: RFIT-ASY-0147; All unexpired lots] |
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| 02 Nov 2023 |
美智睿機器人科技有限公司 Mazor Robotics Ltd. 脊柱外科手術導航定位系統 |
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| 02 Nov 2023 |
Asensus Surgical Inc Senhance Surgical System |
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| 02 Nov 2023 |
Randox Laboratories Ltd. 1) RX Daytona Plus (with ISE); 2) RX Daytona Plus (without ISE); 3) RX Imola-IVD Clinical Chemistry Analyzer; 4) RX Modena-IVD Clinical Chemistry Analyser ; 5) RX Monaco-IVD Clinical Chemistry Analyse |
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| 02 Nov 2023 |
奧林巴斯醫療株式會社電子上消化道內窺鏡 [涉及產品型號規格: GIF-H190] |
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| 02 Nov 2023 |
奧林巴斯醫療株式會社纖維氣管插管內窺鏡 [涉及產品型號規格: LF-GP] |
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| 02 Nov 2023 |
Coapt LLC Coapt ControlSeal Electrode, cutaneous EMG Electrode [UDI/DI: +B618P1/$+202210P1603; All serial numbers] |
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| 02 Nov 2023 |
Coapt LLC Coapt Dome Electrode, Gen2 system, cutaneous electrode [UDI/DI: +B618E0/$+201907E00256B; All Gen2 system serial number] |
|
| 01 Nov 2023 |
Olympus Medical Systems Corp. High Flow Insufflation Unit [Part number: UHI-4, All serial numbers] |
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| 01 Nov 2023 |
Karl Storz Se & Co. Kg Flexible Injection Needle, Injection Needle, Laryngeal Injection Needle [Model or catalog number: 27182A, 26175 PD, 810506, 8598D, 8598B, 8598A; All lots] |
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| 01 Nov 2023 |
GSE Pty Ltd The Insides Driver (a component of The Insides System PS006 and The Insides System Patient Education Model (Part number: MK-1R001)) [1). Driver: Part number: PS001; Lot numbers: LOT0000212, LOT0000227 & LOT0000225; Serial numbers: 01000250, 01000245 & 01000266 & 01000262; 2). Insides System and Patient Education Model; Part numbers: PS006 & MK-1R001; Lot numbers: LOT0000215 & LOT0000236; Serial numbers: 0600007D, 06000079 & 0600008D] |
|
| 01 Nov 2023 |
Philips Big Bore RT, Brilliance CT Big Bore, Brilliance CT Big Bore Oncology [Product Code (Ref): 728242, 728243, 728244; Software: V4.8.0.10421; Device Identifier: (01)00884838095168, (01)00884838059450] |
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| 01 Nov 2023 |
Ortho-Clinical Diagnostics Inc. VITROS Systems |
|
| 01 Nov 2023 |
Vydence Medical - Indústria e Comércio Ltda. ETHEREA-MX System |
|
| 01 Nov 2023 |
Balt Extrusion HYBRID and SONIC |
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