S 3421

The Medical Device Recall Improvement Act of 2025 aims to modernize how medical device recalls are handled by requiring manufacturers to use an electronic format for notifications to the Food and Drug Administration (FDA). This will ensure quicker and more efficient communication about device issues, including detailed information about the device, risks, and necessary actions for patients and healthcare providers. The bill also mandates that manufacturers notify patients directly about recalls affecting devices used outside of medical facilities, particularly those implanted or used with vulnerable populations.