HR 6594

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. This will ensure faster and more efficient communication about device problems to the Food and Drug Administration (FDA) and ultimately to patients and healthcare providers. The bill establishes a standardized electronic system for recall information, including specific data elements and a publicly accessible database, and mandates that manufacturers notify patients about potential risks associated with recalled devices.