FDA alerts clinicians to potential harms from OTC infant monitoring devices | Image credit: Contemporary Pediatrics

The FDA issued a safety communication warning consumers, caregivers, and health care providers about the risks of using unauthorized infant monitors that claim to measure and track vital signs such as heart rate, oxygen saturation, breathing rate, and body temperature. According to the agency, many infant monitoring devices currently marketed over the counter (OTC) have not received FDA authorization, and users should seek FDA-authorized devices.

The federal agency emphasized that inaccurate or missed readings from unauthorized monitors could result in unnecessary medical interventions or, conversely, delays in seeking care for serious symptoms. The agency further cautioned that no infant monitoring products have been cleared or approved to prevent or reduce the risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).

Risks Associated With Unauthorized Devices

The FDA noted that unauthorized monitors may fail to detect important changes, issue false alarms, or cause adverse reactions such as burns or rashes.

Potential risks include:

• Failure to detect significant changes in vital signs.
• Delayed treatment for serious symptoms due to over-reliance on alerts.
• Inaccurate alerts that may prompt unnecessary medical interventions.
• Adverse tissue reactions linked to certain devices.

Devices are sold in multiple forms, including wearable sensors for the foot or torso, under-mattress sensors, and wall-mounted cameras. Regardless of form, these products require FDA marketing authorization to be legally marketed in the United States.

The FDA recommendations for consumers, caregivers, and clinicians

• Avoid using unauthorized monitors marketed for vital sign measurement.
• Do not use any product claiming to prevent or reduce SIDS or SUID.
• Check the FDA’s De Novo and 510(k) databases to confirm whether a device is authorized; authorized infant monitors will carry the product code QYU.
• Consult health care providers for recommendations on FDA-authorized devices if medical care depends on accurate monitoring.

For clinicians, the agency advised discussing risks with caregivers and assisting them in selecting appropriate, authorized monitoring devices when needed.

The warning follows routine surveillance of the medical device market, which identified unauthorized products being sold to consumers through online marketplaces and direct-to-consumer channels.

“The FDA is committed to fostering responsible digital health innovation while prioritizing patient safety in this rapidly advancing field,” the announcement stated.

Further recommendations for parents/caregivers²

Sleep positioners have been linked to infant deaths over the years. These devices, often designed with bolsters or wedges to keep babies in a certain sleep position, can create suffocation hazards if infants roll, slide, or become trapped against the product or crib. The FDA noted that these risks exist regardless of whether such products make medical claims.

The FDA discourages consumers from purchasing items marketed with these claims and advises caregivers to consult health care professionals before using new medical products for their infants.

Read more: Smart infant monitors: a pediatrician’s guide

References:

1. Do not use unauthorized infant devices for monitoring vital signs: FDA safety communication. FDA. Press release. Published September 16, 2025. Accessed September 17, 2025. https://www.fda.gov/medical-devices/safety-communications/do-not-use-unauthorized-infant-devices-monitoring-vital-signs-fda-safety-communication?utm_medium=email&utm_source=govdelivery
2. Recommendations for parents/caregivers about the use of baby products. FDA. Updated May 3, 2023. Accessed September 17, 2025. https://www.fda.gov/medical-devices/baby-products-sids-prevention-claims/recommendations-parentscaregivers-about-use-baby-products