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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.

LIFEPAK EXPRESS defibrillator

FDA Recall
Terminated ·Medtronic Emergency Response Systems, Inc.·Product code MKJ·January 31, 2006

Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold outside of the United States).

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code LFR·February 10, 2006

Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104

FDA Recall
Terminated ·Lumenis Inc.·Product code GEX·February 1, 2006

Allura Xper FD10/10 x-ray system

FDA Recall
Terminated ·Philips Medical Systems North America Co. Phillips·Product code IZI·February 6, 2006

Roche brand Accu-Chek Aviva Bonus Pack Display; Catalog number 045659066001. (Distributed within the U.S.)

FDA Recall
Terminated ·Roche Diagnostics Corp.·Product code LFR·November 9, 2005

Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore

FDA Recall
Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·November 14, 2005

Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311.

FDA Recall
Terminated ·Boston Scientific Scimed·Product code DQY·May 24, 2004

BD 1 mL Allergist tray with 26G x 3/8 in. BD Safety Glide.

FDA Recall
Terminated ·Becton Dickinson & Company·Product code MEG·October 25, 2005

BBL GasPak Pouch System and BBL GasPak CampyPouch System, Catalog numbers 260651 and 260656, packed in boxes of 25

FDA Recall
Terminated ·Becton Dickinson & Co.·Product code KZJ·November 23, 2005

Milex 60cc Handy-Vak Locking Syringe Ref: MX500

FDA Recall
Terminated ·CooperSurgical, Inc.·Product code FMF·November 1, 2005