Medical device recalls High risk

BearCare, Inc. recalls Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in n…

Recall date
May 10, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1633-2023
FDA classification
Class I
Brand / firm
BearCare, Inc.
Sold / distributed
US Nationwide distribution.

Why it was recalled

There have been reports of skin burns to children wearing the device.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20

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