{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "147873",
      "product_res_number": "Z-0138-2017",
      "event_date_initiated": "2016-06-23",
      "event_date_posted": "2016-10-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-01-26",
      "res_event_number": "74542",
      "product_code": "FEB",
      "k_numbers": [
        "K103264"
      ],
      "product_description": "OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector",
      "code_info": "Model: OER-Pro, All serial numbers affected",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "address_2": "PO Box 610",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-0610",
      "additional_info_contact": "Laura Storms\n484-896-5688",
      "reason_for_recall": "New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Olympus America Inc. (OAI) mailed a letter to customers informing them that they are issuing an updated Operation Manual for the OER-Pro Automated Endoscope Reprocessor.\nThe following actions were asked to be taken:\n-Olympus has discontinued previously distributed copies of the OER-Pro Operation Manual. \n-  Inspect your inventory of Operation Manuals and discard any existing inventory of OER-Pro Operation Manuals.     \n- Implement use of the enclosed OER-Pro Operation Manual, which contains the new Warning on pages 73 and 80.\n- Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the requirement to perform precleaning and manual cleaning of Olympus duodenoscopes prior to placing the duodenoscopes in the OER-Pro for high level disinfection.  \n- Additional copies of the new OER-Pro Operation Manual can be obtained by contacting our Technical Assistance Center at 1-800-848-9024, option 1, or by indicating on the enclosed questionnaire. Additional Operation Manuals will be mailed to your facility - Please indicate on the enclosed questionnaire that you have received this notification. Fax the completed form to (484) 896-7128.",
      "product_quantity": "2, 686 units",
      "distribution_pattern": "Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY",
      "openfda": {
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          "K230930",
          "K173590",
          "K914524",
          "K944249",
          "K102996",
          "K243433"
        ],
        "device_name": "Accessories, Cleaning, For Endoscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "2150060",
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        "fei_number": [
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