Patients would get clearer, faster warnings about recalled medical devices.
This bill would ensure patients receive easy-to-understand warnings through their healthcare providers when certain medical devices they use are recalled. It would also create a new electronic system for companies to report recalls to the government and for the public to access this information.
Today, there is no required electronic system for reporting medical device recalls, and patient notification for device risks through healthcare providers is not explicitly mandated. If this bill becomes law, medical device manufacturers would have to use a new electronic system to report recalls, and patients would receive warnings about risks from certain high-risk recalled devices they've used, shared by their healthcare providers. The FDA would also create a public online database of recall information.
S 3421 · 119th Congress · December 10, 2025 · AI Summary by gemini-2.5-flash · 9/10
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