{
  "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": 10
    }
  },
  "results": [
    {
      "cfres_id": "192775",
      "product_res_number": "Z-1061-2022",
      "event_date_initiated": "2022-04-01",
      "event_date_created": "2022-05-12",
      "recall_status": "Open, Classified",
      "res_event_number": "89880",
      "product_code": "FBO",
      "k_numbers": [
        "K945185"
      ],
      "product_description": "CYSTO-URETHRO-FIBERSCOPE REF 11272C1\n\nCYSTOSCOPE, 15FR X 370MM, ADULT\nREF 11272C2 and Kit Number 11272CK2\n\nCYSTO-URETHRO-FIBERSCOPE\nREF 11272CU1 and Kit Number 11272CUK1",
      "code_info": "11272C1 n/a Flexible Cysto-Urethroscope Fiberscope Z18449US-BD (08-2018)\nUDI Code: 4048551226100;\n11272C2 11272CK2 Flexible Cystoscope Z18449US-BD (08-2018)\nUDI Code: 4048551226100;\n11272CU1 11272CUK1 Flexible Cystoscope Z18449US-BD (08-2018)\nUDI Code: 4048551226162;\n\nAll Serial Numbers manufactured/distributed since January 2018.",
      "firm_fei_number": "3007475226",
      "recalling_firm": "Karl Storz Endoscopy",
      "address_1": "2151 E Grand Ave",
      "city": "El Segundo",
      "state": "CA",
      "postal_code": "90245-5017",
      "reason_for_recall": "Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 04/01 and 6/2022, the firm emailed an \"Urgent Medical Device Recall\" letter to customers and followed up with a hardcopy letter on 04/07-08/2022 via their Third Party contractor informing customers of a labeling update to correct the instructions for use for certain flexible urological endoscopes and advise that high-level disinfection should not be used as a method of reprocessing.  Supplemental validation testing of the efficacy of the manual high-level disinfection process using CIDEX OPA was performed.  Testing showed that required efficacy level of disinfection using CIDEX OPA was not achieved.  To the extent included in the current applicable instructions for use, the following methods are being removed as reprocessing methods from the instructions for use of the affected endoscopes.\n+Manual High-Level Disinfection:\n-Cidex-OPA\n-Revital-Ox\" RESERT (e.g., 2.0% Accelerated Hydrogen Peroxide solution).\n+Automated Endoscope Reprocessor:\n-Medivators AER\n-Reliance EPS\n-EvoTech ECR\nCustomer Actions:\n1.\tImmediately discontinue use of all high-level disinfection methods for reprocessing affected endoscopes.\n2.\tThe affected endoscopes should be sterilized after each use by one of the sterilization methods recommended in the instructions for use specific to each endoscope.\n3.\tIf your facility does not have access to a sterilization method recommended in the applicable instructions for use, immediately discontinue use of the affected endoscopes and return products to KARL STORZ.\n4.\tEnsure all relevant personnel in your organization are aware of recall.\n5.\tUpdated instructions for use will be available at https://spwebspace.karlstorz.com/sites/HLDCorrection/SitePages/Home.aspx . Once the updated instructions for use are available, discard any prior versions of the instructions for use. \n\nQuestions:\n\nTelephone: \t1-888-352-9616\nFax:\t\t1-888-912-7088\nE-Mail:  \tkarlstorz7041@sedgwick.com",
      "product_quantity": "All Serial Numbers manufactured/distributed since January 2018",
      "distribution_pattern": "U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, 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, SD, TN, TX, UT, VA, VT, WA,WI, WV, and WY.\n\nO.U.S.: Mexico, Lebanon, and South Korea",
      "openfda": {
        "k_number": [
          "K972979",
          "K904797",
          "K011496",
          "K934649",
          "K243409",
          "K870679",
          "K962474",
          "K062918",
          "K131364",
          "K935163",
          "K082046",
          "K080780",
          "K945185",
          "K941992",
          "K943668",
          "K061646",
          "K843084",
          "K951972",
          "K244001"
        ],
        "registration_number": [
          "3011050570",
          "8010047",
          "3010202439",
          "3010707607",
          "9610595",
          "3014279513",
          "3004644065",
          "3012322232",
          "3014342096",
          "1319639",
          "2020550",
          "9610617",
          "3006546082",
          "3007055279",
          "9611102",
          "3003790304",
          "9614434",
          "3005465238",
          "1418479",
          "3001614464",
          "1221826",
          "1519132",
          "3013247477"
        ],
        "fei_number": [
          "3011050570",
          "1000138054",
          "3002964398",
          "3010707607",
          "3002808001",
          "3007475226",
          "3014279513",
          "3004644065",
          "3012322232",
          "3014342096",
          "3002808268",
          "3002808273",
          "2020550",
          "3002807795",
          "3006546082",
          "3007055279",
          "3003790304",
          "3005465238",
          "1418479",
          "3001614464",
          "1221826",
          "1519132",
          "3013247477"
        ],
        "device_name": "Cystourethroscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}