FDA Alerts Consumers on Unauthorized Blood Pressure and Infant Monitoring Devices

The U.S. Food and Drug Administration (FDA) issued warnings about unauthorized over-the-counter devices for measuring blood pressure and monitoring infant vital signs. Many such devices sold without FDA marketing authorization may provide inaccurate readings, posing health risks.

The FDA highlighted that inaccurate blood pressure measurements can lead to misdiagnosis or delayed treatment for hypertension or hypotension. Similarly, unauthorized infant monitors for heart rate, oxygen saturation, breathing, and temperature can result in unnecessary medical care or delayed response to emergencies. The agency emphasized that these devices are not substitutes for adult supervision or safe sleep practices.

Past actions include a warning to Whoop for its unauthorized blood pressure feature, while Owlet successfully gained FDA clearance for its “smart socks” after clinical validation. Consumers are advised to verify device authorization via FDA 510(k) and de novo databases using product codes “DXN” (blood pressure) and “QYU” (infant monitoring).

22-09-2025