{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191488",
      "product_res_number": "Z-0638-2022",
      "event_date_initiated": "2021-12-13",
      "event_date_created": "2022-02-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-12-26",
      "res_event_number": "89404",
      "product_code": "FEB",
      "k_numbers": [
        "K190969",
        "K201920"
      ],
      "product_description": "OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories",
      "code_info": "All serial numbers.\nUDI: 04953170404047",
      "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": "SAME\n484-896-5000",
      "reason_for_recall": "The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed\ninstead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the\nalcohol cycle, resulting in a ineffective endoscope\nreprocessing and patient exposure to residual detergent",
      "root_cause_description": "Process control",
      "action": "Olympus issued Urgent Medical Device Correction letter dated 12/13/21. Letter states reason for recall, health risk and action to take:\n1. Please immediately perform an inspection of your installed OER-Elite units as described in the Attachment 1 Alcohol Rinse Inspection . If you require assistance, please contact your local Endoscopy Support Specialist (ESS).\n2. If the inspection check does not pass, stop using the OER-Elite and endoscopes reprocessed with that\nOER-Elite. Contact Olympus TAC at 1-800-848-9024, option 1 for further instruction.\nIf the inspection check passes, you may continue to use your OER-Elite.\n3. Access the Olympus recall portal to indicate that you have received this notification and to report the\nresults of the inspection. Go to https://olympusamerica.com/recall. Enter the recall number \"0404\"\nand provide your contact information as indicated in the portal.\nAn Olympus Endoscopy Support Specialist (ESS) will reach out to you to schedule an on-site inspection of the\nOER-Elite detergent and alcohol tubing assembly for final confirmation. If you do not know your local ESS,\nplease contact our Olympus TAC at 1-800-848-9024 to connect you with your local ESS.\nIn addition, if you have further distributed this product, please reach out to those facilities and notify them at once of this field action and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this field action notification letter.\n\n If you require additional information, please do not hesitate to contact me at Cynthia.Ow@Olympus.com.",
      "product_quantity": "295 units",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "k_number": [
          "K000216",
          "K181472",
          "K082988",
          "K162128",
          "K923687",
          "K850268",
          "K933354",
          "K140977",
          "K012309",
          "K915402",
          "K201920",
          "K243433",
          "K103264",
          "K181865",
          "K830026",
          "K063876",
          "K941134",
          "K061430",
          "K060458",
          "K921179",
          "K082392",
          "K954745",
          "K820152",
          "K915620",
          "K914145",
          "K840208",
          "K173590",
          "K973558",
          "K944776",
          "K213833",
          "K914524",
          "K924655",
          "K102996",
          "K152189",
          "K944249",
          "K040883",
          "K162120",
          "K961607",
          "K172677",
          "K964871",
          "K120357",
          "K941648",
          "K924135",
          "K190969",
          "K122172",
          "K241168",
          "K914442",
          "K924103",
          "K230930",
          "K923672",
          "K810818",
          "K061899",
          "K932930",
          "K901439",
          "K101158",
          "K093106",
          "K092387"
        ],
        "device_name": "Accessories, Cleaning, For Endoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "3018094310",
          "2647580",
          "3005987240",
          "1222168",
          "3005646850",
          "1220592",
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          "1418479",
          "3000251274",
          "9680353",
          "2084725",
          "3011050570",
          "9610849"
        ],
        "fei_number": [
          "3018094310",
          "2647580",
          "3005987240",
          "1222168",
          "3002964398",
          "3005646850",
          "1220592",
          "1219930",
          "3002807391",
          "3008157119",
          "3003012447",
          "3024021261",
          "3003662624",
          "1527821",
          "2150060",
          "3002807795",
          "3042172882",
          "3003950207",
          "2523209",
          "1000080301",
          "3004097451",
          "3015392401",
          "1418479",
          "3000251274",
          "3011050570"
        ]
      }
    }
  ]
}