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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.

Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V

FDA Recall
Terminated ·Eagle Vision Inc·Product code KYF·April 12, 2006

Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software

FDA Recall
Terminated ·Affymetrix, Inc.·Product code NSU·April 26, 2005

Kimberly Clark * Facet Block Tray * Single Use * Sterile * Rx only * Manufactured by Ballard Medical Products, Draper, Utah, 84020 USA * Distributed in the U.S. by Kimberly Clark Global States, Inc., Roswell, GA 30076, USA

FDA Recall
Terminated ·Kimberly-Clark Corporation·Product code CAZ·March 15, 2006

SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

FDA Recall
Terminated ·Beckman Coulter Inc·Product code LEH·March 30, 2006

Stratus CS STAT Fluorometric Analyzer cTnI DilPak (CCTNI-D) in vitro diagnostic.

FDA Recall
Terminated ·Dade Behring Inc.·Product code MMI·April 3, 2006

Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid pathway; extension set: 19'', 3.2 mL Vol., with injection site and male Luer Lock adapter, manifold extension set: 46'', 6.2 mL Vol, male luer adapter, and minivolume extension set: 10'', 0.7 mL Vol, injection site and stationary swivel lock T-connector; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·December 15, 2005

Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155

FDA Recall
Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only

FDA Recall
Terminated ·Medtronic Sofamor Danek USA Inc·Product code KWQ·February 2, 2007

RF Denervation Probe, 15 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain. Product Number: 7210272

FDA Recall
Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code GXI·January 19, 2007

HTA Console System, 230 Volt , French, Product Number: 56001FO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)

FDA Recall
Terminated ·Boston Scientific Corporation One Boston·Product code MNB·January 24, 2007