{
  "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": "2026-10-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "209776",
      "product_res_number": "Z-3224-2024",
      "event_date_initiated": "2024-07-23",
      "event_date_posted": "2024-09-24",
      "recall_status": "Open, Classified",
      "res_event_number": "95220",
      "product_code": "FGA",
      "k_numbers": [
        "K232370"
      ],
      "product_description": "Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123",
      "code_info": "All Lots/UDI: (01)04048551234099",
      "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. Kath Strange\n424-218-8201",
      "reason_for_recall": "Various medical device product IFUs contain reprocessing modalities that  have not been reviewed and/or approved for safety and efficacy by the FDA.",
      "root_cause_description": "Process design",
      "action": "On August 2, 2024, Karl Storz -Endoskope issued a \"Urgent: Medical Device Correction\" Notification to affected consignees via UPS Ground. Karl Storz asked consignees to take the following actions: \n\n1.\tImmediately discard any previous revisions of the IFU.\n2.\tAccess the updated e-IFU at Karl Storz website\n3.\tPass on this Urgent Medical Device Correction to all users of the products listed  and all other persons who need to be aware within your organization. \n4.\tIf you have further distributed the products listed, please identify and promptly notify those recipients of this notice and updated e-IFU.\n5.\tReturn the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt.\n6.\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.\n7.\t(Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.)",
      "product_quantity": "5 units",
      "distribution_pattern": "US Nationwide distribution including in the states of 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, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, Guam.",
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          "K853486",
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          "K770729",
          "K791182",
          "K940594"
        ],
        "device_name": "Kit, Nephroscope",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
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}