• Medical Devices
  • Press releases issued more than 60 days ago are accessible in the archive links shown by year at the top of the page. A more complete listing of Medical Device Recalls can be found on FDA’s Medical Device Recalls  page.
Date Brand Name Product Description Reason/ Problem Company Details/ Photo
05/10/2013 Symbios   GoPump Rapid Recovery System kits and GOBlock kits   Potential for excessively high flow rates Symbios Medical Products Select to View Firm Press Release Select to View Image of Product Label
05/02/2013 Medtronic   Deep Brain Stimulation (DBS) lead kits   Deep Brain Stimulation (DBS) lead damage Medtronic, Inc. Select to View Firm Press Release
04/15/2013 InsuLinx   Blood Glucose Meter   lnsuLinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. Abbott Select to View Firm Press Release
04/10/2013 Stryker Corporation   ShapeMatch Cutting Guides   Due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance Stryker Corporation Select to View Firm Press Release
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