Medical Device Recall Improvement Act of 2025

S 3421 requires medical device manufacturers and importers to use a standardized electronic system for recall notifications. This system must include specific mandatory information like device identifiers, risk details, and patient safety instructions, and must be shared with health professionals and patients for high-risk recalls (e.g., implanted, life-sustaining, or pediatric devices). The bill mandates that manufacturers submit these notifications electronically to the FDA within 180 days of the system's launch, with the FDA reviewing them within 2 business days. It also creates a public, searchable database of all recall information. The law directly affects device manufacturers, healthcare facilities, and patients receiving affected devices.