Medical Device Recall Improvement Act of 2025

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 6594 Introduced in House (IH)] <DOC> 119th CONGRESS 1st Session H. R. 6594 To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES December 10, 2025 Ms. Schakowsky (for herself and Mr. Carson) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Medical Device Recall Improvement Act of 2025''. SEC. 2. REGULATION OF MEDICAL DEVICE RECALLS. Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), is amended by inserting after section 518A of such Act the following: ``SEC. 518B. ELECTRONIC NOTIFICATION FORMAT FOR DEVICE RECALLS. ``(a) Electronic Notification Format for Device Recalls.-- ``(1) In general.--Not later than 2 years after the date of enactment of the Medical Device Recall Improvement Act of 2025, the Secretary shall publish a form and manner for notifications of a recall. ``(2) Content.--The form and manner prescribed by the Secretary under paragraph (1) shall-- ``(A) be electronic; ``(B) include mandatory data elements, including-- ``(i) the name of the manufacturer or importer; ``(ii) the contact information and address of the manufacturer or importer; ``(iii) the specific reason for the correction or removal from the market of the device; ``(iv) t