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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 Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·February 25, 2026

COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

Airway Exam Kit, DYKE1796

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 8, 2026

MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

FDA Enforcement
Class II ·Ongoing·Medtronic MiniMed, Inc.·April 1, 2026

MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)

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

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;

FDA Enforcement
Class II ·Ongoing·Angiodynamics, Inc.·April 29, 2026

Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

FDA Enforcement
Class II ·Ongoing·Centinel Spine, Inc.·February 25, 2026

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·April 15, 2026

Azurion 5 M12; System Code: (1)722227, (2)722231;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.

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