{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Jose",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71534",
      "recalling_firm": "American Medical Systems Innovation Center - Silicon Valley",
      "address_1": "3070 Orchard Dr",
      "address_2": "N/A",
      "postal_code": "95134-2011",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the countries of:  Argentina France Morocco, South Africa,  Australia, Germany, Netherlands, Spain,  Austria, Greece, New Zealand, Sri Lanka,  Belgium, Guatemala, Norway, Switzerland,  Bolivia, India, Panama, Thailand,  Brazil, Ireland, Peru, Turkey,  Canada, Israel, Poland, United Kingdom,  Chile, Italy, Portugal, United States,  Colombia, Korea, Qatar, Uruguay,  Costa Rica, Lebanon, Romania,  Finland, Malaysia and Saudi Arabia.",
      "recall_number": "Z-2177-2015",
      "product_description": "Tool, Stripper W/BLD, 14S, Autoclavable;    The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.",
      "product_quantity": "16,710 total affected devices",
      "reason_for_recall": "validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products",
      "recall_initiation_date": "20150528",
      "center_classification_date": "20150721",
      "termination_date": "20160119",
      "report_date": "20150729",
      "code_info": "Model 80-10003-002;  All product manufactured from April 8, 2012 to April 8, 2015"
    }
  ]
}