{
  "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": "72258",
      "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": "US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan.",
      "recall_number": "Z-0418-2016",
      "product_description": "Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU,   ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT.  Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.",
      "product_quantity": "79 units (US) and 985 units (Internationally)",
      "reason_for_recall": "A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.",
      "recall_initiation_date": "20150831",
      "center_classification_date": "20151215",
      "termination_date": "20180321",
      "report_date": "20151223",
      "code_info": "Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107    Model Number: ED-200XT: Serial Number: 8681034    Model Number: ED-250XT: Serial Number: HD077A008    Model Number: ED-310XU: Serial Number: 8591013    Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026    Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022    Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100    Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020    Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051"
    }
  ]
}