Class 1 Device Recall Walnut Thermometer

• Date Initiated by Firm: May 10, 2023
• Date Posted: June 08, 2023
• Recall Status: Terminated on August 07, 2024
• Recall Number: Z-1633-2023
• Recall Event ID: 92275
• Product Classification: Thermometer, clinical color change - Product Code FQZ
• 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
• Code Information: Lot Number 20221115W002
• Recalling Firm/ Manufacturer: BearCare, Inc.; 80 Davids Dr Ste 200; Hauppauge NY 11788-2002
• Manufacturer Reason for Recall: There have been reports of skin burns to children wearing the device.
• FDA Determined Cause: Component design/selection
• 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 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/.
• Quantity in Commerce: 1818 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.