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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.

Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical

FDA Recall
Terminated ·Product code KWS·November 5, 2010

Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U

FDA Recall
Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U

FDA Recall
Terminated ·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010

Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.

FDA Recall
Terminated ·Covidien LP·Product code GEI·December 8, 2010

KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Intended use: Airway management by providing a patent airway to allow patient ventilation.

FDA Recall
Terminated ·King Systems Corp.·Product code CAE·December 15, 2009

Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

FDA Recall
Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2)

FDA Recall
Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

Boston Scientific brand Matrix2 Firm 2D Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.

FDA Recall
Terminated ·Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538 47900 Bayside Pkwy Fremont CA 94538-6515·Product code HGC·October 19, 2010

HiSpeed DX/I (2201000)

FDA Recall
Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

HiSpeed DX/I (2249696)

FDA Recall
Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010