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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 Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B

FDA Enforcement
Class II ·Ongoing·Medline Industries, LP·April 29, 2026

Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;

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

Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.

FDA Enforcement
Class I ·Ongoing·AVID Medical, Inc.·May 13, 2026

Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.

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

Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C

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

Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/SKU DYNJ904981C

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

Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

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

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·April 29, 2026

Flamingo Funnel Small, Model Number SQ20012-01

FDA Enforcement
Class II ·Ongoing·SurgiSmoke Solutions·April 29, 2026

Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

FDA Enforcement
Class II ·Ongoing·Healthmark Industries Co., Inc.·May 6, 2026