Medical Device Recall Improvement Act of 2025
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
This bill modernizes medical-device recall notifications by requiring an electronic recall format, a public database, patient-notification requirements, and related appropriations.
Who Benefits and How
Patients, health professionals, and device user facilities could receive more standardized, faster, and more informative medical-device recall notifications.
Who Bears the Burden and How
Manufacturers, importers, and HHS would face new electronic-notification, database, and patient-notification obligations.
Key Provisions
- Requires HHS to establish an electronic format for medical-device recall notifications.
- Requires manufacturers and importers to use the format and supports a public database of recall notifications.
- Requires recall strategies to include patient notification for certain devices and authorizes related appropriations.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
This bill modernizes medical-device recall notifications by requiring an electronic recall format, a public database, patient-notification requirements, and related appropriations.
Key Policy Areas
Health
Primary Purpose
This bill modernizes medical-device recall notifications by requiring an electronic recall format, a public database, patient-notification requirements, and related appropriations.
Policy Domains
Main Provisions
Identified Gains
Contextual inference, no direct clause citation- Patients, health professionals, and device user facilities receiving clearer and more timely medical-device recall information
Contextual inference, no direct clause citation
Identified Costs
Contextual inference, no direct clause citation- Manufacturers, importers, and HHS officials responsible for implementing the new device-recall notification system
Contextual inference, no direct clause citation
Legislative Progress
In CommitteeMr. Durbin introduced the following bill; which was read twice …
Read twice and referred to the Committee on Health, Education, …
Introduced in Senate
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Patients and health professionals benefiting from a standardized recall-notification system and public database, Patients and health professionals receiving more complete and timely device recall information, Patients receiving recall notifications for certain implanted, life-sustaining, life-supporting, or pediatric devices
Manufacturers and importers required to use the new electronic device-recall notification system, Manufacturers and importers required to use the new recall notification system
HHS officials responsible for the electronic recall format, public database, and implementation funding
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology