Medical Device Recall Improvement Act of 2025

LEGISLATIVE PROGRESS

STEP 2 OF 8

Introduced

In Committee

Reported

Passed House

Passed Senate

Conference

To President

Became Law

Introduced
In Committee
Reported
Passed House
Passed Senate
Conference
To President
Became Law

WHAT THE BILL DOES

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This bill matters because it aims to improve how quickly and clearly people are informed about potentially dangerous recalled medical devices. Currently, the system can be fragmented, making it harder for patients to know if a device they have received is part of a recall, what the risks are, and what steps they should take. If this bill becomes law, it would create a standardized, electronic system for manufacturers to report recalls to the FDA, and critically, it would ensure that patients are more directly notified about recalls of devices that are implanted, life-sustaining, or used in children.

This change could lead to faster responses to device safety issues, potentially preventing injuries or deaths by allowing patients and healthcare providers to act quickly when a problem arises. Without this bill, the current, less standardized system might continue, leaving patients potentially unaware of serious risks associated with medical devices they are using or have in their bodies, making it harder for them to make informed decisions about their health.

KEY PROVISIONS

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Requires the FDA to create a mandatory electronic system for medical device manufacturers to submit recall notifications, including detailed information about the recalled device, risks, and actions to take.

This centralizes and standardizes how critical recall information is reported, making it more consistent and easier for the FDA to track.

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Mandates that for certain high-risk devices (implanted, life-sustaining, or used in children), recall notifications must include specific risk information for patients, and healthcare providers must be instructed to share this with affected patients.

This ensures patients directly receive crucial safety information about devices directly impacting their health, enabling them to take necessary action.

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Directs the FDA to create and maintain a publicly accessible, downloadable electronic database of all medical device recall notifications.

This increases transparency and allows anyone to easily find and access information about recalled medical devices.

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Makes it a "prohibited act" under federal law for manufacturers or importers to fail to submit the required electronic recall notifications or to fail to provide patient notice.

This creates a legal enforcement mechanism to ensure compliance with the new recall reporting and patient notification requirements.

DEADLINES & DATES

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Not later than 2 years after the date of enactment.

Secretary (FDA) must publish the electronic form and manner for recall notifications.

Beginning 180 days after the Secretary establishes the form and manner.

Manufacturers or importers must begin submitting notifications to the Secretary through the new electronic format.

Not later than 2 business days after receipt.

Secretary (FDA) must conduct an initial review of a notification from a manufacturer/importer.

Not later than 3 business days after completion of initial review.

Secretary (FDA) must inform the manufacturer/importer of information to be shared with facilities/professionals.

FUNDING & AUTHORIZATIONS

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AMOUNT	PROGRAM	TYPE	YEARS
$6,700,000	activities under this section and hiring personnel	discretionary	fiscal year 2026
$1,700,000	activities under this section and hiring personnel	discretionary	fiscal year 2027
$1,000,000	activities under this section and hiring personnel	discretionary	each of fiscal years 2028 through 2030

PENALTIES & ENFORCEMENT

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TYPE	AMOUNT	WHO
administrative	Not specified; subject to existing penalties under the Federal Food, Drug, and Cosmetic Act for "prohibited acts."	Medical device manufacturers or importers who refuse or fail to submit required electronic notifications to the Secretary or to facilities/professionals.
administrative	Not specified; subject to existing penalties under the Federal Food, Drug, and Cosmetic Act for "prohibited acts."	Medical device manufacturers or importers who refuse or fail to provide patient notice as required.

GLOSSARY

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Medical Device Recall: When a medical device is removed from the market or a correction is made to it because it poses a health risk or violates FDA regulations.
Device User Facility: A hospital, outpatient diagnostic facility, or other healthcare facility that uses medical devices to treat patients.
Unique Device Identifier (UDI): A unique number or code assigned to a medical device that helps identify it throughout its distribution and use, similar to a barcode on a product.
Federal Food, Drug, and Cosmetic Act: The main law that gives the Food and Drug Administration (FDA) the authority to oversee the safety of food, drugs, and cosmetics, including medical devices, in the United States.
Prohibited Act: An action that is illegal under the Federal Food, Drug, and Cosmetic Act, which can lead to enforcement actions such as fines or legal proceedings.
Class I Recall: The most serious type of recall, for dangerous or defective products that the FDA believes could cause serious health problems or death.
Class III Device: Medical devices that support or sustain human life, are implanted, or present a potential unreasonable risk of illness or injury, requiring the most rigorous regulatory controls by the FDA.

ACTION TIMELINE

2 EVENTS

DEC 10, 25

Introduced in House

INTROREFERRAL

DEC 10, 25

Referred to the House Committee on Energy and Commerce.

INTROREFERRAL

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Energy and Commerce CommitteeReferred

Dec 10, 2025

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Medical Device Recall Improvement Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

SPONSORSHIP

ACTION TIMELINE

BILL INFO

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Discussion

Medical Device Recall Improvement Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

FUNDING & AUTHORIZATIONS

PENALTIES & ENFORCEMENT

GLOSSARY

ACTION TIMELINE

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READER REACTIONS

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Medical Device Recall Improvement Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

SPONSORSHIP

ACTION TIMELINE

BILL INFO

READER REACTIONS

Discussion

Medical Device Recall Improvement Act of 2025

LEGISLATIVE PROGRESS

WHAT THE BILL DOES

KEY PROVISIONS

DEADLINES & DATES

FUNDING & AUTHORIZATIONS

PENALTIES & ENFORCEMENT

GLOSSARY

ACTION TIMELINE

SPONSORS

READER REACTIONS

What do you think?

Discussion

MORE INFORMATION

Committee Referrals

Related Legislation