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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.

Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

FDA Enforcement
Class II ·Ongoing·Medartis AG·March 18, 2026

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

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

Medline medical convenience kits packaged as: STERILE RESUTURE PACK, Kit SKU DYNDL1980A

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·February 18, 2026

Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·March 4, 2026

Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;

FDA Enforcement
Class II ·Ongoing·Straumann USA LLC·April 1, 2026

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

FDA Enforcement
Class II ·Ongoing·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·March 4, 2026

Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182 3. PULMONARY BRONCH PACK, DYNDA2861A

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

GEM Premier 5000 PAK; Part No. 00055360008.

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

COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792

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

Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.

FDA Enforcement
Class II ·Ongoing·Altruan GmbH·March 18, 2026