{
  "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": "2026-04-01",
    "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": "85354",
      "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: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI    OUS: France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, UK",
      "recall_number": "Z-1905-2020",
      "product_description": "Visualase Cooled Laser Applicator System Tubing Set kits    Product numbers:  VCLAS 9735559, 3mm tip/1.65mm catheter  VCLAS 9735560, 10mm tip/1.65mm catheter  VCLAS 9735561, 15mm tip/1.85mm catheter",
      "product_quantity": "4654 units",
      "reason_for_recall": "The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.",
      "recall_initiation_date": "20190708",
      "center_classification_date": "20200505",
      "termination_date": "20241016",
      "report_date": "20200513",
      "code_info": "All kits with lot numbers from 0211041602 through 0217695790",
      "more_code_info": ""
    }
  ]
}