{
  "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": "196728",
      "product_res_number": "Z-0424-2023",
      "event_date_initiated": "2022-11-04",
      "event_date_posted": "2022-12-07",
      "recall_status": "Open, Classified",
      "res_event_number": "91100",
      "product_code": "FJL",
      "k_numbers": [
        "K171965"
      ],
      "product_description": "HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S",
      "code_info": "Model Number/ UDI-DI/ Lot Number\nWA22602S 14042761085127 1000090824\nWA22603S 14042761085134 1000092201\nWA22621S 14042761085172 1000080316\nWA22657S 14042761085301 1000092202",
      "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\n647-999-3203",
      "reason_for_recall": "An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.",
      "root_cause_description": "Packaging process control",
      "action": "On November 4, 2022, the firm notified affected customers. \n\nCustomers were instructed to identify any affected product in their inventory. Affected product should be returned to Olympus, who will issue a credit to the customer upon return of affected product. Those who have distributed the devices outside their facility should notify their customers of this removal action immediately.\n\nTo return product, contact your Olympus customer service representative at 1-800-848-9024.",
      "product_quantity": "186 boxes (930 pieces)",
      "distribution_pattern": "US Nationwide domestic distribution.",
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        "device_name": "Resectoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
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