Sponsors (2)
The bill strengthens patient safety and public-health response by creating standardized, electronic recall notifications, public access to recall data, and stronger enforcement — at the cost of increased compliance and legal burdens (including potential criminal liability), some risk to proprietary information and possible strain on agency capacity, and modest new federal spending.
Patients, caregivers, and clinicians receive clearer, standardized, and faster electronic recall and safety notifications plus a public, downloadable/searchable recalls database, enabling quicker clinical response and reducing harm.
Hospitals and health systems gain dedicated federal funding to build and maintain the electronic recall/notification system, supporting timely rollout and ongoing operation.
Federal and state public-health authorities receive stronger enforcement and reporting tools to improve compliance for medical countermeasures and support faster responses during public-health emergencies.
Manufacturers, importers, hospitals, providers, and small firms will face new and ongoing compliance and reporting costs plus potential criminal liability, increasing legal and administrative expenses and risking a chilling effect on development or distribution of devices and countermeasures.
Tight agency review deadlines (e.g., two business days) could strain HHS review capacity, risking rushed or inconsistent determinations and administrative burden on federal staff.
Public release of detailed device identifiers and production data could expose proprietary information and be misinterpreted by lay audiences, harming manufacturers and potentially confusing patients and caregivers.
Based on analysis of 3 sections of legislative text.
Requires HHS to create a public electronic recall notification system, mandates manufacturers use it to submit and send standardized recall notices (including patient risk info), and adds penalties for noncompliance.
Introduced December 10, 2025 by Janice D. Schakowsky · Last progress December 10, 2025
Requires HHS to build a public electronic system for medical device recall notifications, sets mandatory data fields (including device UDI and patient risk/mitigation info), and makes manufacturers/importers use that system to submit and send recall notices to device user facilities, health professionals, and patients. Establishes short review timelines for the agency, creates a downloadable public database of recall notifications, authorizes multi-year funding to build and run the system, and adds criminal prohibitions for failing to submit required notifications or to provide required patient notices.