{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Vadnais Heights",
      "state": "MN",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95462",
      "recalling_firm": "Iotamotion Inc",
      "address_1": "4205 White Bear Pkwy Ste 600",
      "address_2": "N/A",
      "postal_code": "55110-7648",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Other",
      "distribution_pattern": "Distribution was made to Iowa.  There was no government/military/foreign distribution.",
      "recall_number": "Z-0288-2025",
      "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.",
      "product_quantity": "5 devices",
      "reason_for_recall": "Incorrect GTIN number.",
      "recall_initiation_date": "20240912",
      "center_classification_date": "20241101",
      "report_date": "20241113",
      "code_info": "Lot #D500330, EXP. 2025-01-12, UDI-DI 00850002960006 (the incorrect GTIN number listed on the label).",
      "more_code_info": ""
    }
  ]
}