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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: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 920005PK Product Description: The PKS Cutting Forceps are intended to be passed through a 5mm cannula. Coagulation is achieved using electrosurgical energy under visualization. The device is intended to be used with the PKS electrical generator.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·April 1, 2026

Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.

FDA Enforcement
Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·April 22, 2026

Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.

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

Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.

FDA Enforcement
Class II ·Ongoing·Raz Design Inc·March 18, 2026

Endo-Model Replacement Plateau; Item Number: 15-0027/12;

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

GEM Premier 5000; Part No. 00055430011.

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

Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.

FDA Enforcement
Class II ·Ongoing·Koven Technology, Inc.·April 1, 2026

B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.

FDA Enforcement
Class I ·Ongoing·B Braun Medical Inc·April 22, 2026

Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

FDA Enforcement
Class II ·Ongoing·Steris Corporation·February 18, 2026

Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

FDA Enforcement
Class II ·Ongoing·Cardinal Health 200, LLC·April 8, 2026