{
  "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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      "limit": 1,
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  "results": [
    {
      "cfres_id": "204303",
      "product_res_number": "Z-0568-2024",
      "event_date_initiated": "2023-10-02",
      "event_date_posted": "2023-12-15",
      "recall_status": "Open, Classified",
      "res_event_number": "93417",
      "product_code": "FAS",
      "k_numbers": [
        "K890328"
      ],
      "product_description": "ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,",
      "code_info": "UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label)\nUDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label)\nLot: KR260855",
      "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": "484-896-5000",
      "reason_for_recall": "Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.",
      "root_cause_description": "Labeling Change Control",
      "action": "An Urgent Medical Device Recall notice, issued via UPS Ground October 27, 2023, advises customers of the mislabeled product pouches. Customers are to examine and quarantine any affected inventory, contact Olympus customer service to arrange for return/replacement, and forward notice to any facility where product was further distributed. Acknowledge receipt of the recall notice through the Olympus recall portal at https://olympusamerica.com/recall (enter recall number \"0432\"). Customers requiring additional information may contact Cynthia.Ow@olympus.com.",
      "product_quantity": "162 pieces (27 boxes, 6 per box)",
      "distribution_pattern": "US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.",
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        "device_name": "Electrode, Electrosurgical, Active, Urological",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4300",
        "device_class": "2",
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