{
  "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-2170-2015",
      "product_description": "Fiber Cleaver;   Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP)    The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.",
      "product_quantity": "16,710 total all 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 0010-0760;  All product manufactured from April 8, 2012 to April 8, 2015"
    }
  ]
}