Medical Device Recall Improvement Act of 2025

HR 6594 requires medical device manufacturers and importers to submit recall notifications electronically to the FDA using a standardized format. The format must include specific data like device identifiers, recall reasons, and risk information for both healthcare providers and patients. For certain high-risk recalls (e.g., implanted, life-sustaining devices), manufacturers must also ensure patients receive direct notification about risks and recommended actions. This bill directly affects device manufacturers, the FDA (which reviews notifications within 2 business days), and healthcare facilities that treat patients using recalled devices.