{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Bozeman",
      "state": "MT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89843",
      "recalling_firm": "Neuralynx Inc",
      "address_1": "105 Commercial Dr",
      "address_2": "N/A",
      "postal_code": "59715",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution in the states of AL, CA, IL, MN, NC, RI.",
      "recall_number": "Z-1091-2022",
      "product_description": "ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.",
      "product_quantity": "15",
      "reason_for_recall": "Atlas Stim Headbox (ASHB) was delivered to US customers  under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer  does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance.",
      "recall_initiation_date": "20220314",
      "center_classification_date": "20220513",
      "report_date": "20220525",
      "code_info": "ASHB Part No. 31-0601-0077 (SN0001, SN0002, SN0004, SN0005, SN0006, SN0007, SN0008, SN0009, SN0010, SN0012); ASHB Part No. 31-0601-0132(SN0003, SN0005, SN0006); ASHB Part No. 31-0601-0089(SN0004, SN0006);",
      "more_code_info": ""
    }
  ]
}