{
  "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": "215821",
      "product_res_number": "Z-0027-2026",
      "event_date_initiated": "2025-08-18",
      "event_date_posted": "2025-10-02",
      "recall_status": "Open, Classified",
      "res_event_number": "97507",
      "product_code": "HBB",
      "k_numbers": [
        "K172907"
      ],
      "product_description": "AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.",
      "code_info": "Model Number: GB943R, UDI-DI Number: 04046963805784. Serial Numbers: 4519, 4528, 4533.",
      "firm_fei_number": "3002806315",
      "recalling_firm": "Aesculap AG",
      "address_1": "Am Aesculap-Platz 1 1 am aesculap-platz",
      "city": "Tuttlingen",
      "country": "Germany",
      "additional_info_contact": "Allison Longenhagen\n001-484-2408373",
      "reason_for_recall": "Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as \"Long\" and the ELAN 4 FIXED DURAGUARD LONG was labeled as \"Standard.\"",
      "root_cause_description": "Process control",
      "action": "Asculap notified consignees with an \"Urgent Field Safety Notice\" dated 8/18/2025 via email. Consignees were instructed to identify affected units, arrange for their return, and complete and return the response form provided with the letter.\n\nIf you have any question, call 484.240.8373 or email:allison.longenhagen@bbraunusa.com.",
      "product_quantity": "3 units",
      "distribution_pattern": "US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.",
      "openfda": {
        "k_number": [
          "K042974",
          "K993851",
          "K061725",
          "K991625",
          "K150801",
          "K013091",
          "K953434",
          "K994175",
          "K895739",
          "K020069",
          "K960630",
          "K090112",
          "K040186",
          "K253772",
          "K163182",
          "K000195",
          "K962483",
          "K954717",
          "K023066",
          "K101168",
          "K172907",
          "K093361",
          "K041754",
          "K980686",
          "K061297",
          "K983092",
          "K972289"
        ],
        "registration_number": [
          "1000200989",
          "3033509898",
          "1834331",
          "3015967359",
          "8030965",
          "3007997036",
          "3008868758",
          "1625507",
          "2647346",
          "3005382983",
          "9610612",
          "3015453963",
          "3010155648",
          "3018094310",
          "3010173425",
          "1649518",
          "3007031059",
          "1723170",
          "3003120897",
          "3016172274",
          "3036756245",
          "1048735",
          "3000270450",
          "3014279513",
          "1061124",
          "2648623",
          "3021632375",
          "2916714",
          "1030489",
          "3004598644",
          "3008812560",
          "3017210488",
          "3004464325",
          "3001239363",
          "1058584",
          "3002807310",
          "3003595343",
          "3014479313",
          "1045254",
          "1828288",
          "1045834",
          "3040335671",
          "3025603301",
          "1017294",
          "9616696",
          "3009417901"
        ],
        "fei_number": [
          "1000200989",
          "3033509898",
          "3015967359",
          "3007997036",
          "3008868758",
          "1000219637",
          "1625507",
          "3005382983",
          "3002807036",
          "2647346",
          "3001236277",
          "3015453963",
          "3010155648",
          "3018094310",
          "3007031059",
          "3003120897",
          "3016172274",
          "3036756245",
          "1000477302",
          "1048735",
          "3000270450",
          "3014279513",
          "2648623",
          "3021632375",
          "2916714",
          "1000512168",
          "3002806315",
          "3004598644",
          "3008812560",
          "3002807305",
          "3017210488",
          "3004464325",
          "3001239363",
          "3002807310",
          "3003595343",
          "3014479313",
          "1045254",
          "1000517638",
          "1828288",
          "1045834",
          "1000306340",
          "3040335671",
          "3003164255",
          "3025603301",
          "1017294",
          "3009417901"
        ],
        "device_name": "Motor, Drill, Pneumatic",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4370",
        "device_class": "2"
      }
    }
  ]
}