The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1633-2023·Announced 2023-06-14

FDA Recalls Walnut Wearable Smart Thermometer Due to Reported Skin Burns

BearCare's Walnut Wearable Smart Thermometer (Model WT20) is being recalled due to reports of skin burns in children ages 0-6. The device was distributed nationwide; 1818 units were affected.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall with reported injury (skin burns in children). The agency's Class I classification establishes a minimum severity of 4 (Severe), and the reported burns represent significant injury consistent with this rating.

Plain-English summary

BearCare, Inc. is recalling the Walnut Wearable Smart Thermometer, Model Number WT20, a medical device designed for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations.

The FDA has received reports of skin burns to children wearing the device. This Class I recall indicates a serious hazard to device users.

The device was distributed nationwide. The recalled lot number is 20221115W002, and 1818 units were affected.

If you have this device, discontinue use and contact BearCare, Inc. for return or replacement instructions. Consult your child's healthcare provider if your child has experienced any adverse reactions from wearing the device.

The recalled product

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
Manufacturer
BearCare, Inc.
Category
Medical Device — Wearable Temperature Monitoring
Hazard
Affected units
1,818

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number 20221115W002

Distribution

Distributed nationwide across the United States.

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