{
  "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": "178073",
      "product_res_number": "Z-0675-2020",
      "event_date_initiated": "2019-11-07",
      "event_date_created": "2019-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-26",
      "res_event_number": "84324",
      "product_code": "KOY",
      "k_numbers": [
        "K970694"
      ],
      "product_description": "Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes.\nOrder No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrode. The Wave Prep cups are a component in the Subject Kit.",
      "code_info": "Kit lot codes: NNX-100001478, NNX-100001480, NNX-100001481, NNX-100001486, NNX-100001488, NNX-100001492, NNX-100001542, NNX-100001559, NNX-100001560, NNX-100001561 (containing Wave Prep lot codes: 30656).",
      "firm_fei_number": "3011184129",
      "recalling_firm": "Neuronetrix Solutions, LLC dba Cognision",
      "address_1": "1044 E Chestnut St",
      "city": "Louisville",
      "state": "KY",
      "postal_code": "40204-6033",
      "additional_info_contact": "David Richardson\n502-561-9040 Ext. 7020",
      "reason_for_recall": "Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia",
      "root_cause_description": "Process control",
      "action": "Cognison notified customers and/or end users  via email and/or telephone. Customer who received more than 20 units of the affected Wave Prep cups were initially notified by phone on 11/7/2019.  All customers were then sent an email with an attached recall letter also on 11/7/2019. Letter states reason for recall, health risk and action to take:\nPlease review your inventory of the Subject Kit (Clinical Grade), Model 3000, Order No. D5000 and immediately discontinue use and quarantine any of the affected product with lot numbers shown above.   Customers have been instructed to dispose of the affected product as medical waste. Customer to return  notice via email to support@cognision.com.  If you dont have any affected product, you may call Cognision Customer Service at 800-561-9040 and inform the Customer Service Representative that you have no affected product.  Alternatively, you mail email support@cognision.com and provide this information",
      "product_quantity": "3,108 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "registration_number": [
          "3035479692",
          "3017417635",
          "3016603542",
          "3011534533",
          "3007517215",
          "3021769057",
          "1214815",
          "3016450032",
          "3008808082",
          "8030128",
          "3006552462",
          "3009308084",
          "3009486864",
          "3038637162",
          "3008973760",
          "3042158718"
        ],
        "fei_number": [
          "3035479692",
          "3017417635",
          "3016603542",
          "3011534533",
          "3007517215",
          "3021769057",
          "1214815",
          "3016450032",
          "3008808082",
          "3006552462",
          "3009308084",
          "3009486864",
          "3038637162",
          "3008973760",
          "3042158718",
          "3006118668"
        ],
        "device_name": "Degreaser, Skin, Surgical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4730",
        "device_class": "1"
      }
    }
  ]
}