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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 convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673D

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

Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440

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

Burlington Medical, Vest

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

Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.

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

Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;

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

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

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

COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537.

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

Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18

FDA Enforcement
Class II ·Ongoing·Diversatek Healthcare·April 29, 2026

Brand Name: Leksell Vantage Arc System REF: 1053958

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·May 6, 2026

Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Number: DYNJ53369C; 7) ANGIO PACK, Model Number: DYNJ53591A; 8) ANGIOGRAPHIC PACK, Model Number: DYNJ57516; 9) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ58722A; 10) ANGIO TRAY W/CHLORAPREP, Model Number: DYNJ62742; 11) CEREBRAL ANGIOGRAM, Model Number: DYNJ67876; 12) CSU CATH MANIFOLD KIT, Model Number: VASC1170A

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