{
  "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": "2026-10-21",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Kennewick",
      "state": "WA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99774",
      "recalling_firm": "Cadwell Industries Inc",
      "address_1": "909 N Kellogg St",
      "address_2": "",
      "postal_code": "99336-7669",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state of TN and the countries of Spain, Vietnam, Malaysia, Saudi Arabia, Thailand, Israel, Mexico, Turkey, Oman, Colombia, Brazil, Belgium, Italy, South Africa, and Switzerland.",
      "recall_number": "Z-0141-2027",
      "product_description": "Brand Name: IOMAX  Product Name: IOMAX Cortical Module  Model/Catalog Number: 190296-200  UDI-DI code: 00840067100653  Product Description: The IOMAX Cortical Module contains a 16-channel amplifier, a low current electrical stimulator, a TCS stimulator, a visual stimulator and an auditory stimulator. The low current stimulator has one (1) constant current output pair with a current range of 0.01-20 mA. The TCS stimulator has nine (9) independent constant current/constant voltage outputs, with current range of 50-1500 mA and voltage range of 50-1000 V.  Component: Is the cortical component of the IOMAX system",
      "product_quantity": "23",
      "reason_for_recall": "Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.",
      "recall_initiation_date": "20260818",
      "center_classification_date": "20261009",
      "report_date": "20261021",
      "code_info": "Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Lot Code: These devices are identified by the serial numbers listed below:  19029607AA0326007 19029607AA0226013 19029607AA0426028 19029607AA0226010 19029607AA0226007 19029607AA0326026 19029607AA0226015 19029607AA0326020 19029607AA0326018 19029607AA0326021 19029607AA0326022 19029607AA0226009 19029607AA0526022 19029607AA0326017 19029607AA0326027 19029607AA0326016 19029607AA0226016 19029607AA0326028 19029607AA0326024 19029607AA0326025 19029607AA0326023 19029607AA0326031 19029607AA0326006",
      "more_code_info": ""
    }
  ]
}