Bill · H.R. 6594· House(119-HR-6594)
Medical Device Recall Improvement Act of 2025
- Introduced
- 12/10/2025
- Last activity
- 12/10/2025 — Referred to the House Committee on Energy and Commerce.
- Sponsored by
- Janice Schakowsky
- Cosponsors
- - 1 - 0
- Introduced
- In Committee
What this bill would do
The Medical Device Recall Improvement Act of 2025 aims to update how medical device recalls are handled by amending the Federal Food, Drug, and Cosmetic Act. It requires the Secretary to establish an electronic format and mandatory data elements for recall notifications. Manufacturers and importers must use this electronic format to submit notifications to the Secretary and subsequently to health professionals and device user facilities. The Secretary is also tasked with maintaining a publicly accessible and downloadable electronic database of these notifications. Additionally, the bill mandates that recall strategies include notice to patients treated with certain types of devices. This includes requirements for specific device types such as those implanted in the human body or used in pediatric populations.
Yes· 3 of 7
Would children be better off under this?+8
The bill specifically mandates recall notifications for devices used significantly in pediatric populations.
Does this make what the government does easier for the public to see?+7
The bill requires the Secretary to maintain a publicly accessible and downloadable electronic database of device recall notifications.
Does this give people more protection from unfair business practices?+6
The bill mandates standardized, electronic, and publicly accessible notifications for medical device recalls to better inform consumers of risks.
The opposite
No question was scored the opposite.
Who it would affect, and how
Potential Positive Impacts for People
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Improved Information Access: 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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Clearer Safety Data for Patients: The electronic format must include specific information for patients regarding the risks presented by a device and any actions they can take to eliminate or reduce those risks (Section 2, subsection (a)(2)(B)(vii)).
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Enhanced Notification for Vulnerable Groups: The bill requires recall strategies to provide notice to patients treated with certain devices, specifically those that are implanted, life-sustaining, life-supporting, or used significantly in pediatric populations (Section 2, section 518C(a) and (c)).
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Mandatory Risk Communication: Manufacturers must include information for health professionals regarding the risks to patients and instruct those professionals to share that information with the patients (Section 2, section 518C(b)).
Potential Negative Impacts for People
- No specific negative impacts are explicitly detailed in the text provided.
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+8Good For People With Disabilities+5Good For Retirees+4Good For Seniors+4
- Governance And Ideology
- Improves Government Transparency+7
- Economy And Finance
- Improves Consumer Protection+6
- Healthcare
- Improves Healthcare Access+5
- 12/10/2025
- Referred to the House Committee on Energy and Commerce.
- 1 Cosponsor added.
- Introduced in House
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.
André CarsonDemocrat · Indiana