Z-1633-2023Class I

Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6...

Name: Z-1633-2023 Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6...
Creator: BearCare, Inc.
Published: 2023-05-10
License: https://open.fda.gov/license/

BearCare, Inc. / initiated 2023-05-10 / Terminated / root cause: design

FDA source

BearCare, Inc. began a recall of Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model... on 2023-05-10. FDA classified it as Class I and gives the reason as "There have been reports of skin burns to children wearing the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1633-2023
Classification: Class I
Status: Terminated
Initiated: 2023-05-10
Posted: 2023-06-08
Terminated: 2024-08-07
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
Product code: FQZ Thermometer, Clinical Color Change
Reason for recall: There have been reports of skin burns to children wearing the device.
Root cause tag: design
FDA 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 [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/.
Quantity in commerce: 1818 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot Number 20221115W002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1633-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1633-2023	Class I	Terminated	Voluntary: Firm initiated	2023-06-14	2023-06-08

Product code FQZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)