{
  "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": "Neuhaus-Schierschnitz",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81519",
      "recalling_firm": "Leoni Fiber Optics GmbH",
      "address_1": "Muhldamm 6",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to the state of: Ohio.",
      "recall_number": "Z-0581-2019",
      "product_description": "Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber  SU-200-TRUE-RT  Label Smartscope packaging.     The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.",
      "product_quantity": "N/A",
      "reason_for_recall": "A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility.     There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal.  Broken seal pouches compromise sterility and could increase the risk of infection if used.",
      "recall_initiation_date": "20181017",
      "center_classification_date": "20181207",
      "termination_date": "20200410",
      "report_date": "20181219",
      "code_info": "096975  00816901020326"
    }
  ]
}