{
  "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": "2026-08-22",
    "results": {
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  "results": [
    {
      "cfres_id": "216763",
      "product_res_number": "Z-0872-2026",
      "event_date_initiated": "2025-10-31",
      "event_date_posted": "2025-12-02",
      "recall_status": "Open, Classified",
      "res_event_number": "97849",
      "product_code": "FEB",
      "k_numbers": [
        "K201920"
      ],
      "product_description": "Olympus OER-Elite",
      "code_info": "Model: OER-Elite;\nUDI: 04953170404047;\nSerial #: All;",
      "firm_fei_number": "3002964398",
      "recalling_firm": "Aizu Olympus Co., Ltd.",
      "address_1": "3 Chome 1-1 1-1 Niiderakita",
      "city": "Aizuwakamatsu",
      "state": "3 Chome",
      "country": "Japan",
      "additional_info_contact": "Cynthia Ow\n647-999-3203",
      "reason_for_recall": "Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance\nschedules and that only properly trained personnel conduct repairs and maintenance.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On October 31, 2025 URGENT Medical Device Safety Alert letters were sent to customers. Actions to be taken: 1. Olympus reminds users to follow the Warnings/Cautions and inspections outlined in all Olympus Endoscope Reprocessor Operation Manuals which are important to reduce the potential risk of fire to the device. 2. Carefully read the content of the notification. 3. Check your inventory for the reference devices and identify any in your inventory. 4. Ensure all personnel are completely knowledgeable and thoroughly aware of the contents of the letter. 5. Acknowledge receipt through the provided information. 6. Forward this notice if any affected product was further distributed.",
      "product_quantity": "6578 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
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          "K093106",
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        ],
        "device_name": "Accessories, Cleaning, For Endoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
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