Bill · S. 3421· Senate(119-S-3421)
Medical Device Recall Improvement Act of 2025
- Introduced
- 12/10/2025
- Last activity
- 12/10/2025 — Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8625)
- Sponsored by
- Richard Durbin
- Cosponsors
- None
- Introduced
- In Committee
What this bill would do
The Medical Device Recall Improvement Act of 2025 aims to improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act. It requires the Secretary to establish an electronic format for these notifications, including mandatory data such as manufacturer details, the reason for the recall, and specific device identifiers. Manufacturers or importers must use this electronic format to submit notifications to the Secretary, who will then review them. The Secretary is also required to maintain a publicly accessible and downloadable electronic database of these notifications. Additionally, the bill mandates specific notification strategies for patients regarding certain types of medical devices.
Yes· 3 of 5
Does this make what the government does easier for the public to see?+7
The bill mandates the creation of a publicly accessible and downloadable electronic database of medical device recall notifications.
Does this give people more protection from unfair business practices?+6
The bill enhances consumer protection by requiring manufacturers to provide clear, specific information about medical device risks and recall actions to the public and healthcare providers.
Would children be better off under this?+5
The bill mandates specific patient notifications for high-risk devices used significantly in pediatric populations.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Increased Transparency and Information Accessibility: The Secretary must maintain an electronic database that is publicly accessible and downloadable, which provides the public with information regarding device notifications (Section 2, subsection (c)).
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Standardized and Detailed Recall Information: The electronic format will include mandatory data elements such as the specific reason for the recall, the unique device identifier, and information regarding the risks presented by the device (Section 2, subsection (a)(2)).
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Direct Risk Mitigation for Patients: For specific high-risk devices—including those implanted in the human body, life-sustaining, life-supporting, or used significantly in pediatric populations—the bill requires that recall strategies provide notice to the patients treated with the device (Section 2, section 518C(a) and (c)).
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Clear Instructions for Healthcare Providers: The bill requires that notifications instruct device user facilities and health professionals to share specific information about the risks of a device with their patients (Section 2, section 518C(b)(2)).
Potential Negative Impacts for People
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Increased Regulatory Requirements for Manufacturers: Manufacturers or importers are required to submit notifications through a specific electronic format and must comply with the Secretary's review and response process (Section 2, subsection (b)).
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Strict Compliance Mandates: Failure to submit notifications according to the established electronic format or failure to provide required patient notices is classified as a prohibited act (Section 3).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Demographic And Interest Groups
- Good For Children+5Good For People With Disabilities+3
- Governance And Ideology
- Improves Government Transparency+7
- Economy And Finance
- Improves Consumer Protection+6
- Healthcare
- Improves Healthcare Access+3
- 12/10/2025
- Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8625)
- Introduced in Senate
One bill Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.