Medical Device Recall Improvement Act of 2025

This bill would require the federal Secretary of Health and Human Services to create an electronic form for medical device recall notices within 2 years. The form would list required details such as the maker or importer, the reason for the recall, the device's unique identifier, and information for health providers and patients about risks and steps to take. Manufacturers and importers would have to use the electronic format to notify the Secretary and then hospitals, other device user facilities, and health professionals, and the Secretary would keep a public, downloadable database of these notices. For certain recalls of implanted, life-sustaining, life-supporting, or child-focused devices used outside facilities, recall notices would have to tell providers to share risk information with patients they treated. Failing to send required notices would become a prohibited act under federal law, and the bill authorizes funding from 2026 through 2030.

Full text and official record on Congress.gov

Sponsors

• Richard J. Durbin Democrat sponsor
• 0 cosponsors