BEUDAMED
    FDA Recall 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

    Recall: Z-1633-2023 · Initiated May 10, 2023

    Recall

    Recall Number
    Z-1633-2023
    Event Number
    92275
    Firm
    BearCare, Inc.
    FEI Number
    3027268949
    Product Code
    FQZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 10, 2023
    Posted
    June 8, 2023
    Terminated
    August 7, 2024
    Address
    80 Davids Dr, Ste 200, Hauppauge, NY, 11788-2002

    Description

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

    Reason

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

    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/.

    Distribution

    US Nationwide distribution.

    Quantity

    1818 units