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Medical Device Recall Improvement Act of 2025

USA119th CongressHR-6594| House 
| Updated: 12/10/2025
Janice D. Schakowsky

Janice D. Schakowsky

Democratic Representative

Illinois

Cosponsors (1)
André Carson (Democratic)

Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
This bill, titled the Medical Device Recall Improvement Act of 2025, mandates the creation of an electronic format for medical device recall notifications. Within two years, the Secretary of Health and Human Services must establish this format, requiring manufacturers and importers to submit comprehensive details such as the reason for recall, specific device identifiers, and information tailored for both healthcare professionals and patients. A key provision requires the Secretary to maintain a publicly accessible, downloadable electronic database of all device recall notifications. Manufacturers must submit these notifications electronically to the Secretary, who will review them and guide what information should be disseminated to device user facilities and health professionals. Furthermore, the bill introduces a requirement for direct patient notification for specific high-risk devices, including those that are implanted, life-sustaining, or significantly used in pediatric populations. Manufacturers must ensure that recall strategies include instructions for healthcare providers to share critical risk information with affected patients. Failure to adhere to these new electronic notification and patient outreach requirements will be classified as a prohibited act under the Federal Food, Drug, and Cosmetic Act.
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Timeline

Bill from Previous Congress

HR 118-5662
Medical Device Recall Improvement Act
Dec 10, 2025

Latest Companion Bill Action

S 119-3421
Introduced in Senate
Dec 10, 2025
Introduced in House
Dec 10, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 118-5662
    Medical Device Recall Improvement Act


  • December 10, 2025

    Latest Companion Bill Action

    S 119-3421
    Introduced in Senate


  • December 10, 2025
    Introduced in House


  • December 10, 2025
    Referred to the House Committee on Energy and Commerce.

Health

Related Bills

  • S 119-3421: Medical Device Recall Improvement Act of 2025

Medical Device Recall Improvement Act of 2025

USA119th CongressHR-6594| House 
| Updated: 12/10/2025
This bill, titled the Medical Device Recall Improvement Act of 2025, mandates the creation of an electronic format for medical device recall notifications. Within two years, the Secretary of Health and Human Services must establish this format, requiring manufacturers and importers to submit comprehensive details such as the reason for recall, specific device identifiers, and information tailored for both healthcare professionals and patients. A key provision requires the Secretary to maintain a publicly accessible, downloadable electronic database of all device recall notifications. Manufacturers must submit these notifications electronically to the Secretary, who will review them and guide what information should be disseminated to device user facilities and health professionals. Furthermore, the bill introduces a requirement for direct patient notification for specific high-risk devices, including those that are implanted, life-sustaining, or significantly used in pediatric populations. Manufacturers must ensure that recall strategies include instructions for healthcare providers to share critical risk information with affected patients. Failure to adhere to these new electronic notification and patient outreach requirements will be classified as a prohibited act under the Federal Food, Drug, and Cosmetic Act.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 118-5662
Medical Device Recall Improvement Act
Dec 10, 2025

Latest Companion Bill Action

S 119-3421
Introduced in Senate
Dec 10, 2025
Introduced in House
Dec 10, 2025
Referred to the House Committee on Energy and Commerce.
  • Bill from Previous Congress

    HR 118-5662
    Medical Device Recall Improvement Act


  • December 10, 2025

    Latest Companion Bill Action

    S 119-3421
    Introduced in Senate


  • December 10, 2025
    Introduced in House


  • December 10, 2025
    Referred to the House Committee on Energy and Commerce.
Janice D. Schakowsky

Janice D. Schakowsky

Democratic Representative

Illinois

Cosponsors (1)
André Carson (Democratic)

Energy and Commerce Committee

Health

Related Bills

  • S 119-3421: Medical Device Recall Improvement Act of 2025
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted