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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.

Arrow ARROWg+ard Quad-Lumen CVCs (Central Venous Catheters)

FDA Recall
Terminated ·Arrow International Inc·Product code FOZ·February 11, 2009

GE Datex-Ohmeda Advance Anesthesia Gas-Machine.

FDA Recall
Terminated ·GE Healthcare·Product code BSZ·February 5, 2009

IV Administration Set with Universal Spike, two Ultrasite Injection Sites, Backcheck Valve and Spin-Lock Connector, Catalog # 352049. For use with Secondary Container.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code FPA·March 27, 2009

Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For use with the Horizon NXT Pump, and OutLook Safety Infusion System.

FDA Recall
Terminated ·B. Braun Medical, Inc.·Product code FPA·March 27, 2009

ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.

FDA Recall
Terminated ·Ossur Engineering, Inc·Product code HAX·November 9, 2008

Bard E LUMINEXX Biliary Stent, Size: 14mm x 30mm, Product Number: ZBM14030.

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code FGE·December 23, 2008

Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7559375 Upper Body radiation shield, Artis T.

FDA Recall
Terminated ·Siemens Medical Solutions USA, Inc·Product code IZI·May 1, 2009

i-STAT EG7+ Cartridge; pH, PCO, PO, Na , K, iCa, Hct. Test include: Electrode Measurement Blood-Gases (Pco2, PO2) and Blood Ph, Electrode, Ion Specific, Potassium, Electrode, Ion Specific, Calcium, Electrode, ion Specific, Sodium and Hematocrit. Catalog number 220300. Abbott Point of Care inc., Abbott Park, IL 60064 USA Intended use is to quantify measurement of sodium, potassium, ionized calcium, oxygen, carbon dioxide, pH and Hematocrit in blood.

FDA Recall
Terminated ·Abbott Point of Care Inc.·Product code CHL·February 23, 2009

Bard E LUMINEXX Biliary Stent, Size: 14mm x 40mm, Product Number: ZBM14040.

FDA Recall
Terminated ·Bard Peripheral Vascular Inc·Product code FGE·December 23, 2008

Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp; 325 Corporate Drive, Mahwah, NJ 07430. The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion.

FDA Recall
Terminated ·Stryker Spine·Product code MNH·April 30, 2009