Recall Z-1633-2023— BearCare, Inc.
Class I · Terminated
Class I FDA medical device recall by BearCare, Inc., initiated 2023-05-10, terminated 2024-08-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20. Reason: There have been reports of skin burns to children wearing the device..
- Recalling firm
- BearCare, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2023-05-10
- Terminated
- 2024-08-07
- Firm location
- Hauppauge, NY, United States
Product description
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
Reason for recall
There have been reports of skin burns to children wearing the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.