Medical Device Recall Improvement Act of 2025

Electronic medical device recall system

If enacted, the bill would require the Secretary to publish an electronic form and format for medical device recall notices within 2 years. Manufacturers and importers would have to submit recall notices to the Secretary through that electronic format starting 180 days after it is posted. The form would require specific fields: manufacturer name and contact, reason for the recall, device details, and the device's unique identifier, plus information for health professionals and patient-facing risk and action steps. The Secretary would review each notice within 2 business days and, within 3 business days after that review, tell the maker what information to share with facilities and clinicians; makers would then notify facilities, clinicians, and patients as required for certain high-risk devices. The Secretary would keep a public, downloadable database of these notifications. The bill would authorize $6.7 million for fiscal year 2026, $1.7 million for fiscal year 2027, and $1.0 million for each year 2028 through 2030 to run the system and hire staff.