Medical Device Recall Improvement Act of 2025

Summary

Creates a standardized electronic system and public database for medical device recall notifications, requires certain patients to be directly notified about specific recalls, and authorizes funding to build and run the system. It also makes failing to submit required recall notifications or to provide required patient notices an unlawful act under the FD&C Act (subject to enforcement and criminal penalties).

• Requires HHS to publish a standardized electronic form and format for device recall notifications within 2 years.
• Manufacturers/importers must use the form beginning 180 days after the form is published.
• HHS must review incoming notifications within 2 business days and issue guidance within 3 business days after that review on what to share.
• Creates a publicly downloadable electronic database of device recall notifications.
• Requires direct patient notification for certain high-risk, implanted, pediatric, or out-of-facility device recalls.
• Makes failure to submit required notifications or to provide required patient notices unlawful under the FD&C Act, exposing parties to enforcement and criminal penalties.
• Authorizes funding to build and run the system ($6.7M in FY2026; smaller amounts in FY2027–FY2030).
• Increases transparency and timeliness of recall information for clinicians, facilities, and patients.