S. 3421 — Medical Device Recall Improvement Act of 2025

This section establishes an electronic notification format for medical device recalls (to be published by FDA not later than two years after enactment), requiring manufacturers and importers to use it for notifications under section 519(g) beginning 180 days after publication—including mandatory data elements such as manufacturer details, recall reason, unique device identifier, and information on risks and actions for device user facilities, health professionals, and patients. It further requires FDA to (1) complete an initial review of notifications within two business days and inform manufacturers/importers within three business days of information to share with facilities and professionals; (2) maintain a publicly accessible, downloadable electronic database of recall notifications; and (3) require recall strategies to notify patients treated with specified class II or III devices (i.e., those implanted, life-sustaining/supporting, or significantly used in pediatric populations outside user facilities) via facilities and professionals for class I or II recalls. (Thus, facilities and professionals must share patient risk information but need not disclose patient data to manufacturers.) The section authorizes $6.7 million for FY2026, $1.7 million for FY2027, and $1 million annually for FY2028-FY2030.

This section adds to the list of prohibited acts under section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) (1) the refusal or failure to submit notifications in accordance with paragraphs (1) and (2) of section 518B(b) and (2) the refusal or failure to provide notice in accordance with section 518C.