Recall Z-1633-2023

BearCare, Inc. · initiated May 10, 2023

Class I Terminated

Class I – dangerous or defective products that could cause serious health problems or death

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

Codes / lots: Lot Number 20221115W002

Reason for recall

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

FDA-determined cause: Component design/selection

Action taken

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@walnutcares.com 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 recall@walnutcares.com for a prepaid shipping label. You can find the recall announcement posted at https://walnutcares.com/.

Details

Recall number
Z-1633-2023
Initiated
May 10, 2023
Posted by FDA
June 8, 2023
Terminated
August 7, 2024
Product code
FQZ – Thermometer, Clinical Color Change
Quantity
1818 units
Distribution
US Nationwide distribution.
Recalling firm
BearCare, Inc., Hauppauge, NY

Official FDA recall record