{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "216332",
      "product_res_number": "Z-0579-2026",
      "event_date_initiated": "2025-10-14",
      "event_date_posted": "2025-11-21",
      "recall_status": "Open, Classified",
      "res_event_number": "97681",
      "product_code": "FDT",
      "k_numbers": [
        "K251867"
      ],
      "product_description": "Brand Name: EVIS EXERA III Duodenovideoscope\nProduct Name: Olympus TJF-Q190V\nModel/Catalog Number: TJF-Q190V\nProduct Description: This instrument is intended to be used with an Olympus video system center, light source,\ndocumentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other\nancillary equipment for endoscopy and endoscopic surgery.",
      "code_info": "Model/Catalog Number: TJF-Q190V;\nUDI: 04953170405563 / 04953170452024;\nSerial Numbers:  All;",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-8229",
      "additional_info_contact": "Cynthia Ow\n647-9993203",
      "reason_for_recall": "Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.",
      "root_cause_description": "Device Design",
      "action": "On October 14, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Carefulle read the notification and ensure that all personnel are completely knowledgeable and thoroughly trained on the content of the letter. Complete the required training provided in the letter. Keep a copy of the notification with the operation manual. It is recommended to receive on-site TJF duodenoscope reprocessing training at your facility. If you have further distributed this product, identify and forward them this notification.",
      "product_quantity": "7023 units",
      "distribution_pattern": "US Nationwide distribution.",
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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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