SEO landing

FDA Device Enforcement Reports

View 10000 FDA Device Enforcement Reports on BEUDAMED, the Better Database on Medical Devices. These records compile FDA actions such as recalls, safety alerts, market withdrawals, and warning letters related to medical devices regulated in the United States. Each entry lists device identifiers, manufacturer information, enforcement dates, and the reason for the action to support quick assessment.

FDA Device Enforcement Reports help clinicians, manufacturers, and health-system buyers assess device safety and regulatory status. Use BEUDAMED to monitor trends, compare enforcement activity across device types, and export data for quality and compliance reviews. Regular review of enforcement reports supports post-market surveillance and informed procurement decisions.

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

FDA Enforcement
Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·June 10, 2026

Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Description: Feeding Tube Kit Component: No

FDA Enforcement
Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 10, 2026

Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No

FDA Enforcement
Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

FDA Enforcement
Class II ·Ongoing·INSPIREMD Inc·June 17, 2026

BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400868, 405652.

FDA Enforcement
Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405632.

FDA Enforcement
Class I ·Ongoing·Becton Dickinson & Company·June 10, 2026

Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316

FDA Enforcement
Class II ·Ongoing·Avanos Medical, Inc.·June 17, 2026

Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044

FDA Enforcement
Class II ·Ongoing·Covidien LLC·June 10, 2026