{
  "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": "Louisville",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73337",
      "recalling_firm": "Medtronic Navigation, Inc.",
      "address_1": "826 Coal Creek Cir",
      "address_2": "N/A",
      "postal_code": "80027-9710",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to states of: FL, NJ, AZ, and NC.",
      "recall_number": "Z-1234-2016",
      "product_description": "BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization    The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation Image Guided Workstation System.",
      "product_quantity": "4",
      "reason_for_recall": "Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA.",
      "recall_initiation_date": "20160222",
      "center_classification_date": "20160323",
      "termination_date": "20160615",
      "report_date": "20160330",
      "code_info": "The adapter kits are not identified with any lot/code numbers. The BioTex Adapter kits were manufactured between 2008 and 2010."
    }
  ]
}