{
  "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-2156-2015",
      "product_description": "Sureflex 150 Lithotripsy Fiber, 5x, Blue;    Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).",
      "product_quantity": "~13,710 units - 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 R-LLF150TG:  All product manufactured from April 8, 2012 to April 8, 2015"
    }
  ]
}