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Terminated

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

FDA Recall Z-1633-2023 · Posted 2023-06-08

Recalling FirmBearCare, Inc.
Recall StatusTerminated
Product CodeFQZ
Date Initiated2023-05-10
Date Terminated2024-08-07
Product Quantity1818 units

Reason for Recall

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

Firm 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 [email protected] and (2) return all rechargeable Walnut Thermometers to BearCare for evaluation using a prepaid shipping label. BearCare is asking all retailers to immediately remove the rechargeable Walnut Thermometer from all online marketplaces and return the product to BearCare. BearCare s records indicate approximately eight hundred thirty-nine (839) outstanding units are in the possession of retailers. BearCare is vigorously investigating these complaints to determine the root cause of the alleged failure, including working with professional consultants to evaluate the hardware and packaging of the device. BearCare has voluntarily decided to remove the rechargeable Walnut Thermometer from the market to mitigate any further risk to the public. Return Instructions: BearCare is asking consumers to return the product to the address below to obtain a full refund of the purchase price. Consumers may contact [email protected] for a prepaid shipping label. You can find the recall announcement posted at https://walnutcares.com/.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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