{
  "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": "210760",
      "product_res_number": "Z-0363-2025",
      "event_date_initiated": "2024-10-21",
      "event_date_posted": "2024-11-12",
      "recall_status": "Open, Classified",
      "res_event_number": "95607",
      "product_code": "NVT",
      "product_description": "Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10\n\nTubing Set, Irrigation, PC",
      "code_info": "Product/Material Number: 031523-10\nUDI-DI code: 04048438006306\nLot Number: 240222",
      "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": "Mrs. Kathy Strange\n774-284-1736",
      "reason_for_recall": "Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.",
      "root_cause_description": "Labeling design",
      "action": "On 10/22/2024, an \"URGENT: MEDICAL DEVICE CORRECTION\" Letters will be sent via email by KARL STORZ informing customers that the firm has become aware that one lot number of misbranded product was distributed to 19 customers.\n\nCustomers are instructed to:\n1.\tPass on this Urgent Medical Device Correction to all users of the products listed above (Table 1) and all other persons who need to be aware within your organization. \n2.\tCommunicate to all applicable users that the product is not to be utilized during spinal procedures.\n3.\tIf you have or may have distributed the products listed, please identify and promptly notify those recipients of this notice.\n4.\tReturn the completed Customer Reply Form by E-Mail to the indicated contact below within 15 calendar days from the date of receipt.\n5.\tPlease report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback.\n\nfor questions send an email to KSEAProductLabeling@karlstorz.com .",
      "product_quantity": "40 units",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.",
      "openfda": {
        "registration_number": [
          "3010155661",
          "9614434",
          "3012263546",
          "2244478",
          "3013831261",
          "3010432890",
          "3002807315",
          "2020550",
          "3010202439",
          "3010707607",
          "2936485",
          "3007495879",
          "3009420598",
          "9610617",
          "3010439239",
          "3014342096",
          "9610632",
          "3010264076",
          "3015972753"
        ],
        "fei_number": [
          "3010155661",
          "3012263546",
          "3002808273",
          "3013831261",
          "3010432890",
          "3007475226",
          "3002807315",
          "2020550",
          "3010707607",
          "2936485",
          "3007495879",
          "3009420598",
          "3010439239",
          "3014342096",
          "3010264076",
          "3015972753",
          "1000136269",
          "3002808026",
          "3002808268"
        ],
        "device_name": "Tubing And Tubing/Filter Fits",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.1700",
        "device_class": "1"
      }
    }
  ]
}