{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "156855",
      "product_res_number": "Z-0335-2018",
      "event_date_initiated": "2017-06-20",
      "event_date_created": "2018-01-12",
      "recall_status": "Open, Classified",
      "res_event_number": "77617",
      "product_code": "BSK",
      "k_numbers": [
        "K150893"
      ],
      "product_description": "Intellicuff Standalone (PN 951001)\n\nUsed to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.",
      "code_info": "Serial No. 1000 thru 2090; P/N 951001",
      "firm_fei_number": "2937708",
      "recalling_firm": "Hamilton Medical, Inc.",
      "address_1": "4990 Energy Way",
      "city": "Reno",
      "state": "NV",
      "postal_code": "89502-4123",
      "additional_info_contact": "Bret Everett\n775-858-3200",
      "reason_for_recall": "Issue related to the performance of the motor in recalled product. During use, motor may cease to function.",
      "root_cause_description": "Component design/selection",
      "action": "Hamilton Medical sent a Recall Notice dated June 20, 2017,  notifying them of the device correction. Consignees were informed that a Hamilton Representative would be in contact with them regarding the return of any devices. For further questions, please call  (775)  858-3200.",
      "product_quantity": "176 units",
      "distribution_pattern": "US Distribution to IL and TX.",
      "openfda": {
        "k_number": [
          "K142103",
          "K912723",
          "K191858",
          "K102704",
          "K881514",
          "K831577",
          "K192611",
          "K173914",
          "K180991",
          "K112915",
          "K202874",
          "K923800",
          "K092733",
          "K122721",
          "K221477",
          "K150893",
          "K261499",
          "K243562",
          "K220854",
          "K884638",
          "K150157",
          "K902114",
          "K113644",
          "K792265",
          "K833327",
          "K152778",
          "K873614",
          "K102674",
          "K973755",
          "K881178",
          "K901255",
          "K081805",
          "K912352",
          "K951046",
          "K110631",
          "K182548",
          "K900755",
          "K885216",
          "K242642",
          "K152865"
        ],
        "registration_number": [
          "3003935342",
          "2182318",
          "3007740622",
          "3006024395",
          "3004992992",
          "3014766741",
          "3016438694",
          "3018094310",
          "8010485",
          "1417592",
          "3007048256",
          "2951529",
          "3007014520",
          "3030412764",
          "2936999",
          "3009973505",
          "3004365956",
          "2518436",
          "9616567",
          "3016548968",
          "1047843",
          "3042254935",
          "3029906224",
          "2025816",
          "3018226067",
          "3009307931",
          "2031966",
          "8010939",
          "3010326740",
          "3009959868",
          "1314417",
          "3004593495",
          "3007713076",
          "3005803389",
          "3007682555",
          "3011481350",
          "1056553",
          "3010806663",
          "3011137372",
          "3043543260",
          "3014254831",
          "2022648",
          "1221763",
          "3006673317",
          "3009050824",
          "3012072872"
        ],
        "fei_number": [
          "3003935342",
          "3003361161",
          "2182318",
          "3002980729",
          "3005747797",
          "3007740622",
          "3006024395",
          "3004992992",
          "3014766741",
          "3016438694",
          "3018094310",
          "1417592",
          "1000307109",
          "3007048256",
          "3007014520",
          "3030412764",
          "2936999",
          "3009973505",
          "3004365956",
          "2518436",
          "3016548968",
          "1047843",
          "3042254935",
          "3029906224",
          "2025816",
          "3002963732",
          "3018226067",
          "1000132370",
          "3005596530",
          "3009307931",
          "3010326740",
          "3009959868",
          "1314417",
          "3004593495",
          "3007713076",
          "3005803389",
          "3007682555",
          "3011481350",
          "3010806663",
          "3043543260",
          "3002808440",
          "3014254831",
          "2022648",
          "1221763",
          "3009050824",
          "3012072872"
        ],
        "device_name": "Cuff, Tracheal Tube, Inflatable",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5750",
        "device_class": "2"
      }
    }
  ]
}