BEUDAMED
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    QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code IQA·July 30, 2011

    Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;

    FDA Recall
    Terminated ·Therakos Inc·Product code LNR·March 29, 2010

    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.

    FDA Recall
    Terminated ·OrthoPediatrics Corp·Product code HWC·July 24, 2013

    InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker Endoscopy San Jose, for use with the Stryker InfraVision system. Intended use:Medical device for human use, during surgical procedures to transilluminate anatomical structures during surgical procedures with infrared light. It can be used in either open surgical interventions or during laparoscopic procedures. infrared light which is not visible to the human eye is detected by all of Stryker's infrared sensitive cameras. The InfraVision console outputs the infrared light via disposable fibers hooked to the console that are contained in either the E-kit or the U-kit.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code FGS·September 29, 2010

    IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expandable stent. It is intended as a permanently implanted device. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is designed to be crimped onto a non-compliant PTA balloon catheter that is indicated for biliary stent expansion. After mounting onto a balloon catheter, it is deployed and expanded by inflating the balloon.

    FDA Recall
    Terminated ·Product code FGE·December 29, 2005

    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

    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

    Bard E LUMINEXX Biliary Stent, Size 14mm x 60mm, Product Number: ZBM14060.

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

    Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, ev3 Inc, 4600 Nathan lane North, Plymouth, MN 55442-2920, Rx only. In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries.

    FDA Recall
    Terminated ·Product code FGE·November 6, 2009

    Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FGE·January 28, 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

    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

    ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 14mm 80 cm .018" REF PMB 8-5-14-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .018" REF PMP 8-7-14-80

    FDA Recall
    Terminated ·Product code FGE·January 29, 2004

    Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 10 cm, sterile, single use only; Ref 3102.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code FGE·June 18, 2004

    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080603CD; Edwards Lifesciences LLC, Irvine, CA 92614.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007

    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090603CD; Edwards Lifesciences LLC, Irvine, CA 92614.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007

    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060403CD; Edwards Lifesciences LLC, Irvine, CA 92614.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007

    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100403CD; Edwards Lifesciences LLC, Irvine, CA 92614.

    FDA Recall
    Terminated ·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007

    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060601CD

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008