{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "140362",
      "product_res_number": "Z-0418-2016",
      "event_date_initiated": "2015-08-31",
      "event_date_created": "2015-12-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-03-21",
      "res_event_number": "72258",
      "product_code": "FDT",
      "k_numbers": [
        "K944759"
      ],
      "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.",
      "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",
      "firm_fei_number": "2431293",
      "recalling_firm": "Fujifilm Medical Systems U.S.A., Inc.",
      "address_1": "10 Highpoint Dr",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-7431",
      "additional_info_contact": "Ms. Sarah Contreras\n973-686-2482",
      "reason_for_recall": "A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.",
      "root_cause_description": "Device Design",
      "action": "FujiFilm mailed a Medical Device Recall Letter and Tracking/Verification Form dated August 31, 2015,  to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were asked to check their inventory for affected product, if found, affected product should be removed from circulation and returned to Fugifilm.  Customers were also asked to complete and return the enclosed tracking/verification form to Fujifilm Medical Systems USA, Inc., Endoscopy Division (FMSU-ESD), 10 High Point Drive, Wayne, NJ  07470 or via fax to 973-633-8818.  Customers with questions were instructed to contact their Fujifilm sales representative.  For questions regarding this recall call 973-686-2482",
      "product_quantity": "79 units (US) and 985 units (Internationally)",
      "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.",
      "openfda": {
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          "K980465",
          "K143153",
          "K181522",
          "K042076",
          "K193202",
          "K220587",
          "K110833",
          "K962212",
          "K233886",
          "K181745",
          "K192280",
          "K250701",
          "K152257",
          "K210710",
          "K202661",
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          "K161222",
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          "K251867",
          "K193182",
          "K192245"
        ],
        "device_name": "Duodenoscope And Accessories, Flexible/Rigid",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
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        "fei_number": [
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      }
    }
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}