BearCare has issued a voluntary recall of a wearable thermometer product after reports of “minor to severe” skin burns and irritation with the device.
The FDA said there have been at least five complaints about the rechargeable Walnut Wearable Smart Thermometer, which seem to be related to overheating and leakage of corrosive chemicals from the device.
The recall is a Class I—the “most serious type of recall,” according to the regulator—as use of the devices “may cause serious injuries or death.”
The problem seems to be with the battery in the model WT20 unit, as a press release from the FDA recommends that anyone with a Walnut product that has a rechargeable battery should stop using it straight away.
The thermometer is designed to allow continuous monitoring of chest temperature in infants and children aged up to 6, connecting with a cellphone app to allow the readings to be monitored from another room and send alerts if the child’s temperature spiked or dropped.
It was sold through Amazon and Walmart as well as BearCare’s own website between December 2022 and April of this year.
“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,” reads a statement on the Hauppauge, New York-based company’s website.
The thermometer is in a silicone cover the shape of a penguin character that is fixed to the chest and comes with a base station, adhesive strip, charging cable and manual. Around 979 units of the product—which cost around $90 each—were distributed during the five months it was available for sale.
As of June 8, approximately 839 outstanding units were still in the possession of retailers, according to the FDA’s recall database entry.