{
  "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": "Wayne",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78065",
      "recalling_firm": "Fujifilm Medical Systems U.S.A., Inc.",
      "address_1": "10 Highpoint Dr",
      "address_2": "N/A",
      "postal_code": "07470-7431",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "Z-3225-2017",
      "product_description": "FUJINON ED-530XT.    This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.",
      "product_quantity": "362 units",
      "reason_for_recall": "An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device.    The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.",
      "recall_initiation_date": "20170721",
      "center_classification_date": "20170927",
      "termination_date": "20180712",
      "report_date": "20171004",
      "code_info": "All lots/serial numbers"
    }
  ]
}