{
  "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": "Bloomington",
      "state": "IN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73398",
      "recalling_firm": "Cook Inc.",
      "address_1": "750 N Daniels Way",
      "address_2": "N/A",
      "postal_code": "47404-9120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US including GA, ID, LA, OR, SC, TX and Internationally  to CHINA.",
      "recall_number": "Z-1237-2016",
      "product_description": "UltraxxTM Nephrostomy Balloon Set  The Ultraxx\" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx\" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.",
      "product_quantity": "20",
      "reason_for_recall": "Cook Medical is voluntarily recalling specific lots of the Ultraxx\" Nephrostomy Balloon Set and the Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set because of a labeling mix-up.  Cook Medical has received reports of packages labeled as Ultraxx\" Nephrostomy Balloon Set actually containing the  Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set and vice versa.",
      "recall_initiation_date": "20160127",
      "center_classification_date": "20160324",
      "termination_date": "20170517",
      "report_date": "20160330",
      "code_info": "Catalog # UNBS-1 0-15-CS  GPN# G30357  Lot# 5082013  Exp: 06/01/2017"
    }
  ]
}