{
  "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": "210338",
      "product_res_number": "Z-0288-2025",
      "event_date_initiated": "2024-09-12",
      "event_date_posted": "2024-11-01",
      "recall_status": "Completed",
      "res_event_number": "95462",
      "product_code": "QQH",
      "product_description": "iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.",
      "code_info": "Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).",
      "firm_fei_number": "3030411493",
      "recalling_firm": "Iotamotion Inc",
      "address_1": "4205 White Bear Pkwy Ste 600 4205 White Bear Pkwy",
      "address_2": "Ste 600",
      "city": "Vadnais Heights",
      "state": "MN",
      "postal_code": "55110-7648",
      "additional_info_contact": "Khamporn Pendergrass\n651-447-4177",
      "reason_for_recall": "Incorrect GTIN number.",
      "root_cause_description": "Process control",
      "action": "The firm did not issue any communication.  They distributed the devices and saw through their ERP system that the devices had been used.  The remainder of the devices were in the possession of the firm's VP, therefore, not viewed as \"distributed.\"",
      "product_quantity": "5 devices",
      "distribution_pattern": "Distribution was made to Iowa.  There was no government/military/foreign distribution.",
      "openfda": {
        "k_number": [
          "K252339",
          "DEN190055"
        ],
        "device_name": "Powered Insertion System For A Cochlear Implant Electrode Array",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.4450",
        "device_class": "2",
        "registration_number": [
          "3030411493",
          "2030624",
          "3023531666",
          "3031976597"
        ],
        "fei_number": [
          "3000206435",
          "3030411493",
          "3031976597",
          "3023531666"
        ]
      }
    }
  ]
}