{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "189315",
      "product_res_number": "Z-0184-2022",
      "event_date_initiated": "2021-09-10",
      "event_date_created": "2021-10-29",
      "recall_status": "Open, Classified",
      "res_event_number": "88694",
      "product_code": "CAL",
      "product_description": "FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)",
      "code_info": "All LOTs with remaining shelf life",
      "firm_fei_number": "3007475226",
      "recalling_firm": "Karl Storz Endoscopy",
      "address_1": "2151 E Grand Ave",
      "city": "El Segundo",
      "state": "CA",
      "postal_code": "90245-5017",
      "additional_info_contact": "424-218-8201",
      "reason_for_recall": "During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 09/10/21 recall notices were mailed to customers.  \n\nAction to be taken by the user\n1. Immediately quarantine and discontinue use of the affected products.\n2. Pass on this Urgent Field Safety Notice to all users of the products listed above and all other persons who need to be aware within your organization.\n3. If you have distributed the affected products to third parties, please promptly forward this letter to the recipients of the products and indicate contact details of the recipient on the Acknowledgement and Response Form.\n4. Return the Acknowledgment and Response Form by Fax or E-Mail to the contact listed below within 10 calendar days of receipt of this notice.\n5. Get in touch with your KARL STORZ representative to return affected products and to discuss suitable alternative products.\n\nThis notice must be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.\n\nComplete and return the Customer Acknowledgement and Response Form.",
      "product_quantity": "532",
      "distribution_pattern": "US: SC, NH, UT, LA, FL, TX, MA, MO, VA, IA, CA, IL, NC, VT, AL, GA, PA, TN, WI, NY, CO, AZ, NV, ME, MS, DC, IN, KY, MD, OH, MI, WA, KS, OR, AR, MN, NJ, NM, WV, CT.\n\nOUS: Canada",
      "openfda": {
        "k_number": [
          "K951194",
          "K850978",
          "K802331",
          "K852994",
          "K791634",
          "K951195",
          "K872895",
          "K801364"
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        "fei_number": [
          "3004644065",
          "3008268830",
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          "1000292048",
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          "3024026674",
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          "3030656972",
          "3008205331",
          "3009255580",
          "3008439484",
          "3010041511",
          "3014233600",
          "2020550",
          "3011600579",
          "3005273623",
          "3015398570",
          "3010707607",
          "3007127332",
          "1221826",
          "3033010858",
          "3021666757",
          "3009420598",
          "3020984207",
          "3045058049",
          "3012797688",
          "3003759558",
          "1000347621",
          "3014605202",
          "3005747797",
          "3002807657",
          "3002761766",
          "3007532396",
          "3027655341",
          "3004365956",
          "3008185830",
          "1000136269",
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          "3006513362",
          "3012445994",
          "3021010418",
          "3003882387",
          "3002808268",
          "3030516433"
        ],
        "device_name": "Laryngoscope, Non-Rigid",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5530",
        "device_class": "1"
      }
    }
  ]
}