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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.

Philips L17-5 Ultrasound Transducer

FDA Enforcement
Class III ·Ongoing·Philips Ultrasound, Inc·April 1, 2026

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO INTERVENTIONAL RADIOLOGY, Medline SKU # DYNJ64026C; 3. NEURO INERVENTIONAL RADIOLOGY, Medline SKU # VASC1650.

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·April 15, 2026

MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

FDA Enforcement
Class II ·Ongoing·Medtronic MiniMed, Inc.·April 8, 2026

Artelon FlexBand Dynamic Matrix Ref: 31057

FDA Enforcement
Class II ·Ongoing·International Life Sciences·March 18, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)

FDA Enforcement
Class II ·Ongoing·Mentor Texas, LP.·April 8, 2026

Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO

FDA Enforcement
Class II ·Ongoing·Wilson-Cook Medical Inc.·April 22, 2026

Burlington Medical, Wrap Aprons.

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

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

FDA Enforcement
Class II ·Ongoing·Mentor Texas, LP.·April 8, 2026

Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026

CLARITY II Laser System; Model No. 1110200210.

FDA Enforcement
Class II ·Ongoing·Lutronic Corporation·March 18, 2026