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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.

Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 18, 2026

eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156

FDA Enforcement
Class II ·Ongoing·Civco Medical Instruments Co. Inc.·April 8, 2026

FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 18, 2026

GEM Premier 5000; Part No. 00055445008.

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

Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

FDA Enforcement
Class II ·Ongoing·Ultradent Products, Inc.·April 8, 2026

Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 8, 2026

MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)

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

GEM Premier 5000 PAK; Part No. 00055407504.

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

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00

FDA Enforcement
Class II ·Ongoing·Reflexion Medical, Inc.·April 8, 2026