Original Post
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: Walnut Wearable Smart Thermometer
- Product Model Number: WT20
- Product Lot Number: 20221115W002
- Devices Recalled in the U.S.: 979
- Dates Distributed: December 1, 2022 – April 1, 2023
- Date Initiated by Firm: May 10, 2023
Device Use
The rechargeable Walnut Wearable Smart Thermometer is a reusable thermometer that is paired with an application on a mobile phone. It is intended for home use and continuously monitors the body temperature of infants and children 0 to 6-years-old.
Reason for Recall
BearCare, Inc. is recalling the rechargeable Walnut Wearable Smart Thermometer after receiving 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.
BearCare, Inc. reports five complaints related to this issue.
Who May Be Affected
- Children, infants, and neonates using the Walnut Wearable Smart Thermometer.
- Parents and caregivers using the Walnut Wearable Smart Thermometer on their infant or young child.
What to Do
On May 10, 2023, BearCare, Inc. sent an Urgent Medical Device Recall letter to customers and issued a press release that included the following recommended actions:
Consumer Actions
- Immediately discontinue use of all Walnut Thermometers that use a rechargeable battery.
- Seek immediate medical care if you see any burns or irritation on your child’s skin after using the device.
- Confirm receipt of the recall notice by email to [email protected].
- Return for evaluation all rechargeable Walnut Thermometers to BearCare using a prepaid shipping label that can be requested by emailing [email protected].
Retailer Actions
- Immediately remove rechargeable Walnut Thermometers from all online marketplaces and return the product to BearCare.
Contact Information
Customers with questions should contact BearCare, Inc. at [email protected].
Additional Resources
- Medical Device Recall Database entry
- Company Press Release: BearCare Voluntarily Recalls Rechargeable Walnut Thermometer Due to the Potential for Skin Burns
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
