The pilot programme might reduce risk when using LDTs for oncology drug treatment decisions. Image credit: Shutterstock/Tada Images.

The US Food and Drug Administration (FDA) has identified BearCare’s recall of its smart thermometer devices as a Class I recall – the most severe designation given when a device may cause serious injury or death.

The New York-based company voluntarily recalled its Walnut Thermometers in May following reports of skin burns and irritation. The FDA said that potential overheating and leakage of corrosive chemicals from the device could cause skin injuries and even death.

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Not only are children, infants, and neonates at risk but also parents and caregivers who operate the device.

According to the FDA, the identification of the recall being Class I means a “situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death”.

Last month, BearCare pulled the product from retailers and told customers to stop using the thermometers and return them so the company can troubleshoot the devices. A total of 979 devices have been recalled.

Before it was removed from online marketplaces such as Amazon, Walmart and the company’s online store, the Walnut Thermometer was available as an over-the-counter rechargeable device that monitors the chest temperature in children up to six years old. It was sold for a total of five months from late 2022 to early-2023.

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In a company statement announcing the recall, BearCare said users can tell if their device is failing by looking for “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”. The company also said to observe the skin application area for irritation, redness, and warmth.