S.3421

Establishes an electronic format for medical device recall notifications to improve patient safety.

The Medical Device Recall Improvement Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to establish an electronic format for medical device recall notifications. Manufacturers and importers must submit notifications to the Secretary of Health and Human Services, who will review them within two business days. The Secretary will then inform the manufacturer or importer of the information to be shared with device user facilities and health professionals within three business days.