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U.S. Department of Health and Human Services

Medical Device Recalls

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Recalling Firm
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Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemo... 2 Apr-26-2016 Hardy Diagnostics
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 s... 2 Apr-26-2016 Intuitive Surgical, Inc.
BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for d... 2 Apr-26-2016 Becton, Dickinson and Company, BD Biosciences
Automated peritoneal dialysis (APD) cycler 2 Apr-25-2016 Baxter Healthcare Corp.
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Numbe... 2 Apr-25-2016 Boston Scientific Corporation
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hanse... 2 Apr-25-2016 Hansen Medical Inc
PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HP... 2 Apr-25-2016 Stryker Endoscopy
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. 2 Apr-24-2016 3M Company - Health Care Business
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only. 2 Apr-22-2016 ev3, Inc.
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional... 2 Apr-22-2016 Siemens Medical Solutions USA, Inc

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