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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.

Bicarby Dialysate; Model number: RFP-400-G;

FDA Enforcement
Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·June 17, 2026

Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14

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

Plum Duo Infusion Pump, 40002-0401

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

BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.

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

CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

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

Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851)

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

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

FDA Enforcement
Class II ·Ongoing·Boston Scientific Neuromodulation Corporation·June 17, 2026

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

FDA Enforcement
Class II ·Ongoing·DeRoyal Industries Inc·June 10, 2026

BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 405621, 405735.

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

Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 Software Version: N/A Product Description: CESK HARRIS METHODIST Component: No

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