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FDA Medical Device Recalls

View 10000 FDA Medical Device Recalls on BEUDAMED, the Better Database on Medical Devices. This searchable listing aggregates recall notices issued by the U.S. Food and Drug Administration for devices removed, corrected, or returned due to safety, labeling, or performance concerns. Each record summarizes the recall reason, affected models and lots, recall class, and recommended actions for patients and providers.

Searchable filters help stakeholders identify affected manufacturers, device models, and recall classes (Class I–III) and review timelines and remediation steps. Healthcare providers and purchasers can use these records to verify whether inventory is affected and to implement recommended corrections, returns, or patient notifications.

Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

FDA Recall
Terminated ·Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.·Product code LRS·October 3, 2017

Central Venous Catheter Tray

FDA Recall
Terminated ·Cook Inc.·Product code DQY·October 13, 2017

Liquid Cardiac Control CQ5053

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JJY·August 8, 2017

Bentson Wire Guide

FDA Recall
Terminated ·Cook Inc.·Product code DQX·October 13, 2017

12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.

FDA Recall
Terminated ·Medical Components, Inc dba MedComp·Product code NFK·February 23, 2018

Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078

FDA Recall
Terminated ·Merit Medical Systems, Inc.·Product code OJV·September 20, 2017

MONTERIS MEDICAL NEUROBLATE SYSTEM, used for MRI-guided neurosurgical ablation.

FDA Recall
Terminated ·Monteris Medical Corp·Product code GEX·October 5, 2017

J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

FDA Recall
Terminated ·Bovie Medical Corporation·Product code GEI·February 8, 2018

AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code JQP·January 18, 2018

SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FBN·December 20, 2017