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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.

Femoral Nail, A/R, R1500 T2 Femur 12x380 mm, Product Number 18281238S

FDA Recall
Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HSB·April 27, 2018

AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount.

FDA Recall
Terminated ·AESDEX·Product code FZP·April 2, 2018

Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

FDA Recall
Terminated ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code LWS·June 21, 2018

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336

FDA Recall
Terminated ·Howmedica Osteonics Corp.·Product code JDI·May 22, 2018

Safety Sideport Knife 1.0mm 45, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

FDA Recall
Terminated ·Beaver Visitec·Product code EMF·May 14, 2018

Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 9; 00-7713-009-00

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code LPH·May 30, 2018

microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA

FDA Recall
Terminated ·FHC, Inc.·Product code HAW·May 10, 2018

Discovery IGS 740 Interventional Fluoroscopic X-ray Systems

FDA Recall
Terminated ·GE Medical Systems, SCS·Product code OWB·March 29, 2018

Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 11; 00-7713-011-00

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code LPH·May 30, 2018

PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879

FDA Recall
Terminated ·Ethicon, Inc. Us·Product code GAW·May 7, 2018