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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.

REF 8788, 8mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.

FDA Recall
Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code LXH·January 28, 2010

Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor instrument is a reusable surgical instrument used to separate the femoral nail from the locking bolt after nail implantation/fixation in trauma surgeries

FDA Recall
Terminated ·Zimmer Inc.·Product code LXH·July 5, 2010

FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FGE·April 27, 2010

Pediatric Paddles attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitors.

FDA Recall
Terminated ·Physio Control, Inc.·Product code LDD·November 17, 2008

FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code FGE·April 27, 2010

DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.

FDA Recall
Terminated ·Minntech Corp·Product code FEB·June 15, 2010

Philips Intellivue Patient Monitor Model MP70 (M8007A)

FDA Recall
Terminated ·Philips Healthcare Inc.·Product code MHX·June 28, 2010

St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094.

FDA Recall
Terminated ·St. Jude Medical Cardiovascular Division·Product code DYB·June 28, 2010

Stryker power cord kits, Stryker Medical, Portage, MI.

FDA Recall
Terminated ·Stryker Medical Div. of Stryker Corporation·Product code INK·March 19, 2010

CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIAL: Stainless Steel Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava 3.5MM - Non-Sterile. Implantation: used in Food and Ankle surgeries.

FDA Recall
Terminated ·Wright Medical Technology Inc·Product code HRS·June 7, 2010