{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 20
    }
  },
  "results": [
    {
      "cfres_id": "218156",
      "product_res_number": "Z-1438-2026",
      "event_date_initiated": "2025-11-11",
      "event_date_posted": "2026-02-20",
      "recall_status": "Open, Classified",
      "res_event_number": "98288",
      "product_code": "FJL",
      "k_numbers": [
        "K931995"
      ],
      "product_description": "Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.",
      "code_info": "Model: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). All lots.",
      "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": "Complaints of the ceramic tip of the resection sheath breaking have been received.",
      "root_cause_description": "Under Investigation by firm",
      "action": "An URGENT MEDICAL DEVICE CORRECTIVE ACTION notice was sent to consignees 1/6/2026. Consignees are instructed to ensure all personnel are familiar with the contents of the notification. Users are to adhere to the Inspection and Testing and Caution sections of the IFU for both the resection/inner sheath, as well as the Inspection Before Each Use section in the Resectoscope System Manual. Additional instructions include having an extra resection sheath and inspect during and after procedure for device fragments. Consignees are to retain a copy of the notification with the IFU. Consignees with any questions may contact Cynthia Ow at Cynthia.Ow@Olympus.com or by phone at 947-999-3203.",
      "product_quantity": "29 units",
      "distribution_pattern": "US Nationwide Distribution.",
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        "device_name": "Resectoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
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