FDA Device recall Z-1633-2023
Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical…
- FDA Device
- Class I
- terminated
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class I recall of Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical… by Bearcare, citing there have been reports of skin burns to children wearing the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1633-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2023-05-10 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bearcare |
| Distribution | US |
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.
Identifiers
| code_info | Lot Number 20221115W002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1633-2023%22
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