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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.

MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software

FDA Enforcement
Class II ·Ongoing·Auris Health, Inc·February 25, 2026

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·March 4, 2026

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·February 11, 2026

GEM Premier 5000; Part No: 00055415011.

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

PIE PAK Models: P2HC-A, P2HC-S, P2HC

FDA Enforcement
Class II ·Ongoing·Edermy LLC·March 4, 2026

Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·February 25, 2026

Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

FDA Enforcement
Class I ·Ongoing·Olympus Corporation of the Americas·February 25, 2026

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;

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

Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·February 25, 2026