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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.

Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P

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

BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C

FDA Enforcement
Class II ·Ongoing·Kico Knee Innovation Company·June 10, 2026

BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No

FDA Enforcement
Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE (20MMX40MM). Model/Catalog Number: IVS-RBT-001. i.v.STATION is an automation device used for preparation and compounding of IV medications, which also applies labels to compounded preparations for identification and traceability.

FDA Enforcement
Class I ·Ongoing·Omnicell, Inc.·May 20, 2026

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

FDA Enforcement
Class II ·Ongoing·GE Medical Systems, LLC·May 20, 2026

Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

FDA Enforcement
Class I ·Ongoing·Medline Industries, LP·May 20, 2026