Recall Z-1633-2023 ยท FQZ Thermometer, Clinical Color Change
BearCare, Inc.
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
| Date | Jun 8, 2023 (initiated May 10, 2023) |
| Status | Terminated |
| Reason | There have been reports of skin burns to children wearing the device. |
| Root cause | Component design/selection |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter dated 5/10/23 was sent to customers. Actions to take: BearCare is asking consumers to immediately discontinue use of all Walnut Thermometers employing a rechargeable battery and return the product to BearCare for a refund. BearCare s records indicate approximately nine hundred seventy-nine (979) units are in the possession of consumers. Any consumer noting burns or irritation on their child s skin should seek immediate medical care. Additionally, BearCare is asking consumers to: (1) confirm receipt of the recall notice via email to recall@w |
| Quantity | 1818 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.