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Medical Device Recall Improvement Act of 2025

USA119th CongressS-3421| Senate 
| Updated: 12/10/2025
Richard J. Durbin

Richard J. Durbin

Democratic Senator

Illinois

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The Medical Device Recall Improvement Act of 2025 aims to enhance the transparency and efficiency of medical device recalls by establishing a new electronic notification system. It directs the Secretary of Health and Human Services to develop an electronic format for recall notifications, which manufacturers and importers must use to submit detailed information to the FDA. This electronic format will include crucial data elements such as the specific reason for the recall, the unique device identifier, and comprehensive information tailored for both healthcare professionals and patients regarding risks and necessary actions. Following FDA review, manufacturers are required to electronically notify device user facilities and health professionals, and the Secretary must maintain a publicly accessible electronic database of these notifications. A significant provision requires recall strategies to include direct patient notification for specific high-risk devices, such as those that are implanted, life-sustaining, or used in pediatric populations, ensuring patients receive critical safety information. Failure to comply with these new electronic notification and patient notice requirements will be considered a prohibited act under the Federal Food, Drug, and Cosmetic Act, strengthening enforcement and accountability.
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Timeline

Bill from Previous Congress

S 118-2907
Medical Device Recall Improvement Act
Dec 10, 2025

Latest Companion Bill Action

HR 119-6594
Introduced in House
Dec 10, 2025
Introduced in Senate
Dec 10, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8625)
  • Bill from Previous Congress

    S 118-2907
    Medical Device Recall Improvement Act


  • December 10, 2025

    Latest Companion Bill Action

    HR 119-6594
    Introduced in House


  • December 10, 2025
    Introduced in Senate


  • December 10, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8625)

Health

Related Bills

  • HR 119-6594: Medical Device Recall Improvement Act of 2025

Medical Device Recall Improvement Act of 2025

USA119th CongressS-3421| Senate 
| Updated: 12/10/2025
The Medical Device Recall Improvement Act of 2025 aims to enhance the transparency and efficiency of medical device recalls by establishing a new electronic notification system. It directs the Secretary of Health and Human Services to develop an electronic format for recall notifications, which manufacturers and importers must use to submit detailed information to the FDA. This electronic format will include crucial data elements such as the specific reason for the recall, the unique device identifier, and comprehensive information tailored for both healthcare professionals and patients regarding risks and necessary actions. Following FDA review, manufacturers are required to electronically notify device user facilities and health professionals, and the Secretary must maintain a publicly accessible electronic database of these notifications. A significant provision requires recall strategies to include direct patient notification for specific high-risk devices, such as those that are implanted, life-sustaining, or used in pediatric populations, ensuring patients receive critical safety information. Failure to comply with these new electronic notification and patient notice requirements will be considered a prohibited act under the Federal Food, Drug, and Cosmetic Act, strengthening enforcement and accountability.
View Full Text

Suggested Questions

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

Timeline

Bill from Previous Congress

S 118-2907
Medical Device Recall Improvement Act
Dec 10, 2025

Latest Companion Bill Action

HR 119-6594
Introduced in House
Dec 10, 2025
Introduced in Senate
Dec 10, 2025
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8625)
  • Bill from Previous Congress

    S 118-2907
    Medical Device Recall Improvement Act


  • December 10, 2025

    Latest Companion Bill Action

    HR 119-6594
    Introduced in House


  • December 10, 2025
    Introduced in Senate


  • December 10, 2025
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8625)
Richard J. Durbin

Richard J. Durbin

Democratic Senator

Illinois

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 119-6594: Medical Device Recall Improvement Act of 2025
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted