Date Issued: September 16, 2025

The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers, and health care providers of risks related to using unauthorized infant monitors for measuring and monitoring vital signs (such as heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature). Many infant monitors currently sold over-the-counter (OTC) for vital sign monitoring do not have FDA marketing authorization, meaning the FDA has not evaluated the safety and effectiveness of those devices. The FDA recommends looking for an FDA-authorized device appropriate for your child’s needs.

Infant monitors are intended to alert caregivers of values outside of set thresholds, prompting intervention such as calling their doctors or seeking emergency care. Inaccurate measurements from unauthorized devices can lead to unnecessary medical care. These devices may also fail to detect changes in condition, which could delay treatment for serious symptoms or cause the user to miss the detection of a medical condition. These devices have not been evaluated to support monitoring for asthma, apnea, Sudden Infant Death Syndrome (SIDS), Sudden Unexpected Infant Death (SUID), or the overall health condition of infants. Infant monitors are not a replacement for adult supervision or safe sleep practices.

The FDA is not aware of any clinical or scientific evidence that shows that currently available baby products prevent or reduce the chance of SIDS. Be aware that any product marketed with claims to prevent or reduce the chance of SIDS or SUID has not been cleared or approved for that use by the FDA.

Recommendations for Consumers and Caregivers

Do not use unauthorized infant monitors that claim to measure vital signs including heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature. These devices may be sold through online marketplaces or directly from the seller.
- Be aware that the safety and effectiveness of these devices have not been reviewed by the FDA, and the use of these devices could result in inaccurate measurements.
- To see if an infant monitoring device has been evaluated and authorized by the FDA, search the FDA’s De Novo database and 510(k) database using the device name. Devices that have been evaluated and authorized by the FDA will have the product code QYU.
If medical care depends on accurate monitoring, talk to your health care provider about an appropriate FDA-authorized device for your child’s needs.
Do not use baby products with claims to prevent or reduce the chance of SIDS/SUID.
Refer to the FDA’s recommendations for parents and caregivers about the use of baby products.

Recommendations for Health Care Providers

Read and follow the recommendations above for consumers and caregivers.
Talk to your patients’ caregivers about the risks of using unauthorized infant monitors.
Help your patients’ caregivers select an appropriate, FDA-authorized monitoring device, if needed.

Device Description

Infant monitors are devices that are claimed to monitor vital signs such as heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature. These devices alert caregivers to check on infants or prompt intervention. Interventions are actions such as seeking medical or emergency care or changing medications. These monitors may be worn by the infant, such as on the foot or belly, or are contactless, such as a sensor placed under a mattress or a wall-mounted camera.

These devices are required to receive FDA marketing authorization to be lawfully marketed in the United States. These devices do not fall within the FDA’s policy for general wellness products because they are not intended solely for a general wellness use and are not low risk.

Risks of using an infant monitor that has not been authorized by the FDA include:

Failure to detect changes in heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature.
Delays in seeking treatment for serious symptoms due to an over-reliance on alerts to prompt action.
Adverse tissue reactions such as burns or rashes.
Inaccurate alerts leading to unnecessary medical interventions.

Devices that monitor vital signs for infants are manufactured by dozens of companies and sold under multiple brand names. To see if an infant monitoring device has been evaluated and authorized by the FDA, search the FDA’s De Novo database and 510(k) database using the device name. Devices that have been evaluated and authorized will have the product code QYU. No devices, including infant monitors, have been authorized to prevent SIDS or SUID.

FDA Actions

The FDA became aware of unauthorized products being marketed to consumers through routine monitoring of the medical device market. The Agency is taking steps to address unlawfully marketed unauthorized infant monitors that claim to measure vital signs.

The FDA is alerting customers of the risks associated with the use of these unauthorized devices and making the public aware that no devices, including infant monitors, have been authorized to prevent SIDS or SUID.

The FDA is committed to fostering responsible digital health innovation while prioritizing patient safety in this rapidly advancing field.

The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with Your Device

If you think your infant had a problem with inaccurate measurements or experiences any adverse events from using an unauthorized infant monitor, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting can help the FDA improve patient safety by identifying and better understanding the risks associated with the medical devices.