Starting from 1 January 2022, safety alerts related to medical devices not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The Food and Drug Administration (FDA) of United States has posted a Class I recall concerning BearCare, Inc Walnut Wearable Smart Thermometer.
According to the FDA, the manufacturer has received reports of skin burns and irritation resulting from use of the device. Potential overheating and leakage of corrosive chemicals from the device could cause skin irritation, burns, other serious injuries, or death.
The manufacturer is advising the consumer immediately discontinue use of all Walnut Thermometers that use a rechargeable battery and seek immediate medical care if you see any burns or irritation on your child’s skin after using the device.
For further information, please visit https://www.fda.gov/medical-devices/medical-device-recalls/bearcare-inc-recalls-rechargeable-walnut-wearable-smart-thermometers-risks-serious-injury-including
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Jun 2023