{
  "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": "Kuroishi",
      "state": "N/A",
      "country": "Japan",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87074",
      "recalling_firm": "Aomori Olympus Co., Ltd.",
      "address_1": "2 Chome 248-1",
      "address_2": "Okkonoki",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-0964-2021",
      "product_description": "B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract.",
      "product_quantity": "7,400,000 (global); 260,395 (US)",
      "reason_for_recall": "Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.",
      "recall_initiation_date": "20210104",
      "center_classification_date": "20210205",
      "termination_date": "20240311",
      "report_date": "20210217",
      "code_info": "01K, 02K, 03K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK"
    }
  ]
}