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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.

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/SKU DYNJ0774765U

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·May 6, 2026

Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.

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

Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.

FDA Enforcement
Class II ·Ongoing·Clariance-SAS·April 22, 2026

Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVELINE TRAY, Model Number: DM1035; 3) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43

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

Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

FDA Enforcement
Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·April 1, 2026

LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

FDA Enforcement
Class II ·Ongoing·Linkbio Corp.·April 22, 2026

CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 22, 2026

Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY

FDA Enforcement
Class II ·Ongoing·Merit Medical Systems, Inc.·May 6, 2026