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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.

Burlington Medical, Demi Half Aprons.

FDA Enforcement
Class II ·Ongoing·Burlington Medical, LLC·April 8, 2026

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

FDA Enforcement
Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

FDA Enforcement
Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.

FDA Enforcement
Class II ·Ongoing·Hologic, Inc·May 6, 2026

Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 29, 2026

COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

FDA Enforcement
Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 5. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 6. IV START KIT, Medline Kit SKU DYNDV2520; 7. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 8. (Centurion) ARTERIAL LINE BUNDLE, Medline Kit SKU ART255; 9. ON/OFF TRAY, Medline Kit SKU DYNDC2969; 10. CVAD DRESSING CHANGE KIT, Medline Kit SKU EBSI1364A.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

GEM Premier 5000 PAK; Part No. 00055360010.

FDA Enforcement
Class II ·Ongoing·Instrumentation Laboratory·March 18, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 29, 2026