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Faster and Clearer Notifications for Recalled Medical Devices.

This law mandates a standardized electronic system for reporting recalled medical devices, significantly improving transparency and speed for citizens. Crucially, it requires manufacturers to provide clear risk information and recommended actions directly to patients who have used the affected devices. A public database will also be created, allowing anyone to check the status of recalled products.
Key points
Manufacturers must use a new, electronic notification format that includes specific risk information and recommended actions for patients.
Mandatory direct notification to patients regarding the recall of critical medical devices (e.g., implants or life-support equipment).
Creation of a publicly accessible, downloadable electronic database containing all information about recalled devices.
article Official text account_balance Process page
Introduced
Citizen Poll
No votes cast
Additional Information
Print number: 119_HR_6594
Sponsor: Rep. Schakowsky, Janice D. [D-IL-9]
Lustra uses Artificial Intelligence. Verify details in source documents.
Summarized by: gemini-flash-latest
Source data: api.congress.gov
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OFFICIAL LEGAL TITLE

Medical Device Recall Improvement Act of 2025

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_HR_6594.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

What are the main provisions?

Key points include:

  • Manufacturers must use a new, electronic notification format that includes specific risk information and recommended actions for patients.
  • Mandatory direct notification to patients regarding the recall of critical medical devices (e.g., implants or life-support equipment).
  • Creation of a publicly accessible, downloadable electronic database containing all information about recalled devices.
What is the specific legal status?

The current status is Introduced.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Rep. Schakowsky, Janice D. [D-IL-9].

What is the latest detailed status?

The latest detailed status is: Referred to the House Committee on Energy and Commerce.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-31.

CATEGORIES

Health