United States 119th Congress Status: In Committee 2 D cosponsors

HR 6594 — Medical Device Recall Improvement Act of 2025

Last action — Referred to the House Committee on Energy and Commerce.

  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill is in committee in the House. Introduced December 10, 2025. It must pass committee before a floor vote.

Next likely step: a committee vote, then a floor vote in the House.

Odds of enactment

Low chance

Based on the sponsor, cosponsors, and committee posture, this bill has a low chance of becoming law.

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A statistical estimate from our own model of past outcomes — an insight, not a guarantee. Policymaking is volatile.

Prognosis

Stalled 18% · moderate confidence

  • In Committee

    Current position in the legislative process.

  • 2 sponsors

    1 primary, 1 co-sponsors signed on.

  • Single-party support

    Sponsorship is currently within one party (2 D).

Based on stage, sponsorship breadth, committee status, recorded votes, and cross-state momentum — a description of the observable signals, not a prediction.

In plain language

The bill is a new introduction in the House related to energy and commerce.

This bill was introduced in the House and referred to the House Committee on Energy and Commerce for further consideration. No specific details about its contents or implications are provided.

Bill Text

How this bill changes current law

12 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill establishes new requirements for electronic device recall notifications and patient notifications about risks associated with recalled devices.

  • 21 U.S.C. § 331

    "(jjj) The refusal or failure to submit notifications in accordance with paragraphs (1) and (2) of section 518B(b)."

    Adds refusal or failure to submit required electronic recall notifications as a prohibited act.

  • 21 U.S.C. § 331

    "(kkk) The refusal or failure to provide notice in accordance with section 518C."

    Adds refusal or failure to provide patient notification about recalled devices as a prohibited act.

  • 21 U.S.C. § 518B

    SEC. 518B. ELECTRONIC NOTIFICATION FORMAT FOR DEVICE RECALLS.

    Establishes a new section for electronic notification formats for device recalls.

  • 21 U.S.C. § 518B

    (a) Electronic Notification Format for Device Recalls.--

    Introduces a mandatory electronic format for device recall notifications.

  • 21 U.S.C. § 518B

    (b) Notifications.--

    Describes requirements for manufacturers to notify the Secretary and device user facilities electronically.

  • 21 U.S.C. § 518B

    (c) Electronic Database.--

    Requires the Secretary to maintain a publicly accessible electronic database of device notifications.

  • 21 U.S.C. § 518B

    (d) Definitions.--

    Defines key terms related to device recalls and notifications.

  • 21 U.S.C. § 518B

    (e) Authorization of Appropriations.--

    Authorizes funding for activities related to electronic notification processes.

  • 21 U.S.C. § 518C

    SEC. 518C. PATIENT NOTIFICATION.

    Establishes requirements for patient notifications regarding device recalls.

  • 21 U.S.C. § 518C

    (a) In General.--

    Mandates the inclusion of patient notifications in device recall strategies.

  • 21 U.S.C. § 518C

    (b) Compliance.--

    Specifies requirements for notifying healthcare providers about device risks.

  • 21 U.S.C. § 518C

    (c) Affected Devices.--

    Applies patient notification requirements to certain types of device recalls.

Action History

  1. Introduced in House

  2. Introduced in House

  3. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 1 co-sponsors · 545 not signed on

Sponsors (1)

Co-sponsors (1)

Not signed on (545)

545 members have not signed on to this bill.

Show all 545 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

taxation healthcare education health-insurance
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

Who sponsors HR 6594?
HR 6594 is sponsored by Schakowsky, Janice D. (Democratic) and Carson, André (Democratic).
What is the current status of HR 6594?
This bill is in committee in the House. Introduced December 10, 2025. It must pass committee before a floor vote.
Where can I track HR 6594?
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Last checked for changes 3 months ago · updated continuously

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