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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.

Boston Scientific SpyGlass Ocular Reference Number: 4604 UPN M00546040

FDA Recall
Terminated ·Boston Scientific Corporation·Product code KOG·February 7, 2007

NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521.

FDA Recall
Terminated ·Zimmer Inc.·Product code JWH·October 10, 2006

Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.

FDA Recall
Terminated ·Remington Medical Inc.·Product code KNW·January 19, 2007

Gyrus ACMI Tripolar Ultra Cutting Forceps: 10 mm X 32 cm-Reference Number: 006689-901

FDA Recall
Terminated ·Gyrus ACMI Corporation·Product code KNS·February 19, 2007

Baxter Vented Paclitaxel Set; a sterile fluid pathway with polyethylene lined tubing, non-DEHP pump segment, 0.22 micron downstream high pressure filter, injection site, male Luer lock adapter; for use with rigid nonvented solution containers on Colleague and Flo-Gard 6201 and 6301 series pumps; Baxter Healthcare, Deerfield, IL 60015; product code 2C7553

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·February 16, 2007

Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.

FDA Recall
Terminated ·Guidant Cardiac Surgery·Product code MWS·December 1, 2006

LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01

FDA Recall
Terminated ·Hospira Inc.·Product code FPA·December 20, 2006

Alcon Custom-Pak, part #4917-54, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.

FDA Recall
Terminated ·Alcon Laboratories, Inc·Product code HNN·December 22, 2006

VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.

FDA Recall
Terminated ·Viasys Respiratory Care, Inc.dba Bird Products·Product code CBK·January 31, 2007

OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System,

FDA Recall
Terminated ·GE OEC Medical Systems, Inc·Product code JAA·February 9, 2007