Medical Device Recall Improvement Act of 2025

Sponsor: Janice D. Schakowsky (Democratic-IL)December 10, 2025

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Introduced

In Committee

Passed One Chamber

Passed Both Chambers

Signed into Law

Referred to the House Committee on Energy and Commerce.

Patients would get clearer, faster warnings about recalled medical devices.

This bill would make it easier for patients to learn about recalled medical devices. It would require device makers to send electronic recall notices and ensure patients are informed about risks for certain devices through health professionals, unlike today where patient notification isn't always mandated. A new public database would also list all recall information.

What Would Change

Today, there isn't a specific rule for medical device companies to use an electronic system for recalls or to directly tell patients about them. If this bill passes, the FDA would set up an electronic system, and companies would have to use it and ensure patients are informed about recalls for certain critical devices through health professionals. A new public database would also make recall information easier to find.

Key Provisions

Requires the Food and Drug Administration (FDA) to create a new electronic system for medical device recall notices.
Makes medical device companies use this electronic system to tell the FDA, hospitals, and doctors about recalls.
Creates a public online database where anyone can find information about recalled devices.
Requires recall plans to ensure patients are notified about recalls for certain serious devices, via health professionals.
Makes it illegal for companies to refuse or fail to follow these new electronic and patient notification rules.

View on Congress.gov

HR 6594 · 119th Congress · December 10, 2025 · AI Summary by gemini-2.5-flash · 9/10

Medical Device Recall Improvement Act of 2025

What Would Change

Key Provisions

Lobbying Activity