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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.

DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

FDA Enforcement
Class II ·Ongoing·Katalyst Surgical, LLC·May 13, 2026

Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 13, 2026

Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM

FDA Enforcement
Class I ·Ongoing·ARROW INTERNATIONAL, LLC·May 20, 2026

LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122

FDA Enforcement
Class II ·Ongoing·Physio-Control, Inc.·May 13, 2026

BD Pyxis MedStation 4000 REF: 303 Medication cabinet

FDA Enforcement
Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (722064), Azurion 7 B12 (722067), Azurion 7 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079, 722224).

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

One Step 10A in vitro diagnostic test

FDA Enforcement
Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

FDA Enforcement
Class II ·Ongoing·Aniara Diagnostica LLC·May 20, 2026

Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor CORONARY ANGIO PACK Model numbers ANCA80AP ANCA80AQ

FDA Enforcement
Class I ·Ongoing·American Contract Systems Inc·May 13, 2026

One Step UTI in vitro diagnostic test REF: 3374

FDA Enforcement
Class II ·Ongoing·DFI Co., Ltd.·May 13, 2026