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The bill strengthens recall reporting, standardization, enforcement, and public access—boosting patient safety and transparency—while imposing new compliance, administrative, and notification burdens that could raise costs, strain agencies and providers, and potentially reduce market availability.
Patients (especially those with implanted, life‑sustaining, or pediatric devices) and their clinicians will receive clearer, more complete, and faster recall risk and mitigation information through standardized electronic submissions and required data elements, improving safety and enabling more informed medical decisions.
Manufacturers and distributors will be required to submit safety notifications and the FDA has clearer enforcement authority to penalize noncompliance, which should increase reporting, compliance, and earlier removal or correction of hazardous products from the market.
The public (patients and providers) gains access to a centralized, downloadable database of device recall notifications, increasing transparency and making it easier for individuals and health systems to look up recall information directly.
Consumers could face reduced product availability if stricter enforcement and liability risk lead manufacturers or distributors to withdraw products or limit market access.
Hospitals, device user facilities, and clinicians will have increased workload to notify patients about specified recalls but receive no dedicated resources for outreach, straining clinical staff and operations.
Manufacturers and importers will face compliance costs and IT burdens to adopt the new electronic submission processes within 180 days, which could be especially onerous for smaller firms.
Based on analysis of 3 sections of legislative text.
Introduced December 10, 2025 by Richard Joseph Durbin · Last progress December 10, 2025
Creates a standardized electronic system and public database for medical device recall notifications, requires manufacturers and importers to use that format, and mandates patient notice for certain implanted, life‑sustaining, life‑supporting, or pediatric devices used outside health care facilities. It also makes failure to submit required electronic notifications or to provide required patient notice an illegal act enforceable under the FD&C Act and authorizes limited funding for implementation.