Date Issued: September 16, 2025

The U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using unauthorized devices that claim to measure or estimate blood pressure. Many blood pressure devices currently sold over-the-counter (OTC) 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 needs.

Inaccurate blood pressure measurements can lead to errors in diagnosing hypertension (high blood pressure) or hypotension (low blood pressure), which may result in delayed treatment or lack of treatment. This can lead to patient harms, such as stroke, heart attack, heart failure, kidney failure, cognitive decline, and early death. Because high blood pressure often has no physical symptoms, accurate measurements are critical to preventing serious complications.

Recommendations for Consumers, Patients, and Caregivers

Do not use unauthorized blood pressure devices, including software features on wearables, such as smartwatches and smart rings, that claim to measure blood pressure. These devices may be sold through online marketplaces or directly from the seller.
- Be aware that the safety and effectiveness of unauthorized devices have not been reviewed by the FDA, and the use of these devices could result in inaccurate measurements of blood pressure levels.
- To see if a blood pressure device has been evaluated and authorized by the FDA, search the FDA’s 510(k) database using the device name. Devices that have been evaluated and authorized will generally have the product code DXN.
If your medical care depends on accurate blood pressure measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.

Recommendations for Health Care Providers

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

Device Description

Blood pressure devices are products that are claimed to measure or estimate blood pressure. These devices may alert users to check their pressure and/or prompt intervention. Interventions might include seeking medical or emergency care and/or changing medications. These devices are typically worn on the wrist or finger. 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.

Potential risks of using these devices that have not been authorized by the FDA may include:

Failure to detect changes in blood pressure.
Delays in seeking treatment for serious symptoms due to an over-reliance on alerts to prompt action.
Inaccurate alerts leading to unnecessary medical interventions.
Inaccurate readings resulting in inappropriate medication changes.

Devices that measure blood pressure are manufactured by dozens of companies and sold under multiple brand names. To see if a device has been evaluated and authorized by the FDA, search the FDA’s 510(k) database using the device name. Devices that have been evaluated and authorized will generally have the product code DXN.

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 blood pressure devices, including software features on wearables, such as smartwatches and smart rings, that claim to measure blood pressure.

The FDA is alerting consumers of the risks associated with these devices and making the public aware of blood pressure devices that claim to measure blood pressure and are unauthorized.

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 you had a problem with inaccurate measurements, or experience any adverse events from using an unauthorized 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.

Questions?

If you have questions, contact CDRH’s Division of Industry and Consumer Education (DICE).

Affected Devices

Any unauthorized software features on wearables, such as smartwatches and smart rings, regardless of brand, that claim to measure or estimate blood pressure.