FDA Medical Device Recalls (openFDA)
BearCare, Inc.: 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 number
- Z-1633-2023
- Recalling firm
- BearCare, Inc.
- 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
- Status
- Terminated
- Initiated
- 2023-05-10
- Posted
- 2023-06-08
- Terminated
- 2024-08-07
- Reason
- There have been reports of skin burns to children wearing the device.
- Root 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
- 1818 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot Number 20221115W002
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQZ
- Firm FEI
- 3027268949
- Firm city
- Hauppauge
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28