HR6594-119

What This Bill Does

The Medical Device Recall Improvement Act of 2025 adds sections 518B and 518C to the Federal Food, Drug, and Cosmetic Act. Within two years, FDA must publish an electronic form and format for device recall notifications with mandatory data fields covering the manufacturer or importer, contact information, recall reason, device identity, unique device identifier and production identifiers, information for device user facilities and health professionals, and patient-facing risk and action information. Beginning 180 days after FDA establishes the format, manufacturers and importers must submit required recall notifications through that electronic format. FDA must conduct an initial review within two business days and, within three business days after that review, tell the manufacturer or importer what information should be shared with device user facilities and health professionals. Manufacturers and importers must then send initial and any necessary subsequent notifications through the electronic format. FDA must maintain a public, downloadable electronic database of device recall notifications. For certain class I or class II recalls of class II or class III devices used outside device user facilities, including implanted, life-sustaining, life-supporting, or significant pediatric-use devices, recall strategies must include patient notice through device user facilities and health professionals.

Who Benefits and How

Patients benefit from clearer and faster recall information about device risks and steps that can reduce harm, especially for implanted, life-sustaining, life-supporting, and pediatric-use devices. Clinicians, hospitals, and device user facilities benefit from standardized recall data that identifies the device, unique device identifier, production identifiers, risk information, and patient instructions. FDA and public-health researchers benefit from a downloadable database that can make recall trends and safety communication easier to monitor.

Who Bears the Burden and How

Medical device manufacturers and importers bear new compliance burdens to submit recall notifications in the FDA electronic format, include mandatory data elements, wait for FDA initial review before sending certain notices, and provide follow-up notices as needed. FDA bears implementation burdens to create the format, review submissions within short deadlines, maintain the public database, and hire personnel, with authorized appropriations of $6.7 million for fiscal year 2026, $1.7 million for fiscal year 2027, and $1 million per year for fiscal years 2028 through 2030. Device user facilities and health professionals must pass recall risk information to affected patients, although they do not have to give patient information to manufacturers or importers.

Key Provisions

• Requires FDA to publish an electronic medical-device recall notification format within two years with mandatory manufacturer, device, UDI, risk, and patient-action data fields.
• Requires manufacturers and importers to submit recall notifications through the FDA electronic format beginning 180 days after the format is established.
• Requires FDA initial review within two business days and FDA feedback within three business days after that review on what information should be shared with facilities and clinicians.
• Creates a public, downloadable FDA database of device recall notifications.
• Requires patient-notification instructions for certain high-risk class I or class II recalls involving implanted, life-sustaining, life-supporting, or pediatric-use devices.