{
  "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,
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  },
  "results": [
    {
      "cfres_id": "142937",
      "product_res_number": "Z-0757-2016",
      "event_date_initiated": "2016-01-08",
      "event_date_posted": "2016-02-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-01-09",
      "res_event_number": "73059",
      "product_code": "FDT",
      "k_numbers": [
        "K080403"
      ],
      "product_description": "Olympus TJF-Q180V flexible gastrointestinal Duodenoscope\n\nProduct Usage:\nThis instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.",
      "code_info": "all codes",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "address_2": "PO Box 610",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-0610",
      "additional_info_contact": "484-896-5000",
      "reason_for_recall": "Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.",
      "root_cause_description": "No Marketing Application",
      "action": "Olympus America Inc. sent an Urgent Notification letter dated January 15, 2016 to customers.  The letter identified the affected product, problem and actions to be taken.  Customers were instructed to inspect inventory for the affected product, Olympus will contact facilities to make arrangements for return of the TJF-Q180V duodenoscope(s) for the elevator mechanism replacement.  For questions call (484) 896-5688.",
      "product_quantity": "4436",
      "distribution_pattern": "US Nationwide Distribution except PR",
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        "device_name": "Duodenoscope And Accessories, Flexible/Rigid",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
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