The FDA has issued urgent warnings about unauthorized blood pressure monitors and infant vital sign monitoring devices being sold over the counter to consumers. These devices, which often include wearable tech features like smartwatches and smart rings, have not received FDA marketing authorization and may provide inaccurate health data.
Physical signs of high blood pressure can be absent, making precise readings essential. The FDA cautions that unapproved blood pressure monitors may lead to missed diagnoses or improper treatment of hypertension or hypotension, posing serious health risks.
Similarly, unauthorized infant monitors that claim to track heart rate, oxygen saturation, breathing, or body temperature are not FDA evaluated. Inaccurate readings from these devices could cause unnecessary medical visits or delayed emergency care.
The FDA emphasizes that infant monitors should never replace adult supervision or safe sleep measures and are not validated to monitor conditions like asthma, apnea, or sudden infant death syndrome (SIDS).
The FDA has previously taken action against companies selling unauthorized devices, including a 2025 warning letter to Whoop for marketing an unapproved blood pressure feature on its wellness wristband. Despite the warning, Whoop has not disabled the feature. In 2021, Owlet received an FDA warning for its “smart socks” infant monitor but later obtained FDA clearance and reintroduced the product.
To protect health, the FDA advises consumers to use only authorized devices when measuring blood pressure or monitoring infant vital signs. Consumers can verify device authorization through the FDA’s 510(k) and de novo databases using product codes “DXN” for blood pressure monitors and “QYU” for infant monitors.
YOU MAY ALSO LIKE
At What Age Does the Risk for SIDS Decrease？
When Do You No Longer Have to Worry About SIDS?
When Does the Risk of Sudden Infant Death Syndrome (SIDS) Decline?
