FDA Warns Against Two Medical Device Products

The Food and Drug Administration has issued public health warnings concerning two named medical device products. In separate advisories, the FDA warned healthcare professionals and the general public not to purchase and use the BEAURER MEDICAL UPPER ARM BLOOD PRESSURE MONITOR and the FIRSTAID CARING FOR LIFE DISPOSABLE FACE MASK.

The notices were published by the FDA as Advisory No. 2026-1601 and Advisory No. 2026-1602.

Blood pressure monitor advisory

In FDA Advisory No. 2026-1601, the FDA identified the BEAURER MEDICAL UPPER ARM BLOOD PRESSURE MONITOR as an unregistered medical device product.

The FDA’s warning states that healthcare professionals and the general public should not purchase and use the named product. The advisory specifically identifies the BEAURER MEDICAL UPPER ARM BLOOD PRESSURE MONITOR in its public health warning.

Disposable face mask advisory

In FDA Advisory No. 2026-1602, the FDA identified the FIRSTAID CARING FOR LIFE DISPOSABLE FACE MASK as an unnotified medical device product.

The FDA likewise warned healthcare professionals and the general public not to purchase and use the named disposable face mask. The notice identifies the FIRSTAID CARING FOR LIFE DISPOSABLE FACE MASK as the product covered by the advisory.

Products named in the notices

• BEAURER MEDICAL UPPER ARM BLOOD PRESSURE MONITOR: identified by the FDA as an unregistered medical device product.
• FIRSTAID CARING FOR LIFE DISPOSABLE FACE MASK: identified by the FDA as an unnotified medical device product.

According to the FDA, both notices are public health warnings directed to healthcare professionals and the general public. The advisories address the purchase and use of the two named products.

For medical-device sales professionals, the FDA notices provide product-specific regulatory information from the publisher. The two advisories distinguish between the blood pressure monitor, which the FDA describes as unregistered, and the disposable face mask, which the FDA describes as unnotified.