- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
Recall Reason DescriptionPotential for injuries, including skin burns & irritation
- Company Name:
- BearCare, Inc
- Brand Name:
- Product Description:
Product DescriptionWearable Smart Thermometer
Hauppauge, NY, May 10, 2023– BearCare, Inc. is initiating a voluntary recall of its rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) due to reports of injuries, including skin burns, by users. The Walnut Thermometer is an over-the-counter rechargeable device intended for continuous chest temperature monitoring of children ages 0-6 years which can be identified by its silicone exterior resembling a cartoon penguin. The product under recall was sold and distributed from December 2022 to April 2023 through Amazon.com, Walmart.com, and www.walnutcares.com.
Components shown above: (1) thermometer unit; (2) base station; (3) adhesive strip; (4) user manual; (5) charging cable.
|Product Name||Distribution Dates||Lot Number||Model Number|
|December 2022 and later||20221115W002||WT20|
How to recognize the device may fail: users may identify a failing device if the user observes any substance leaking from the device’s exterior, any corrosion near the smart sensor on the back of the device, diminished battery life, or connectivity issues with the Walnut App. In addition, a sensation of warming or heat at or near the site or redness and irritation on the skin are also signs of that a device is failing.
Actions to take: Consumer are advised to immediately stop using the product. Caution should be taken if there is evidence of moisture or leakage since this may pose a risk of chemical burns to users as well as caretakers or others handling the product. Given the vulnerable population of neonates and infants, other areas of the body should be checked, including the mouth and eyes due to possible transfer of corrosive fluids that may cause chemical burns or toxicity if swallowed. Seek medical care if you or your child were exposed to moisture coming from the device or experience any symptoms related to this device failure.
BearCare is voluntarily recalling this product after receiving consumer complaints of minor to severe skin burns and skin irritation in children that used the product made BearCare aware of an issue. BearCare prioritizes consumer safety and is thoroughly evaluating these complaints. Due to the potential for injury, the Walnut Thermometer consumers are advised to immediately stop using the product.
BearCare is asking consumers to return the product to the address below to obtain a full refund of the purchase price. Consumers may contact firstname.lastname@example.org or click here for a prepaid shipping label.
80 Davids Dr. #200
Hauppauge, NY 11788
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information