{
  "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": "Terminated",
      "city": "Dallas",
      "state": "TX",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89056",
      "recalling_firm": "Dignitana, Inc.",
      "address_1": "10925 Estate Ln Ste W185",
      "address_2": "N/A",
      "postal_code": "75238-2315",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "US Distribution to states of: LA, NC, NJ, FL, WI, CA, NY, KS, GA, SC, CT and KY.",
      "recall_number": "Z-0825-2022",
      "product_description": "DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling:  The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN),  DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN),   DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN,   Quick Reference Guide   DigniCap Delta (IFU-20190327-02-EN),  The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN),  The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US,  DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN),  DigniCap Delta Procedural Expectations TR- 20190721-02-US,  DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN),  DigniCap Delta Small Wrap Protocol TR-20200714-01-US,  DigniCap Delta Training Tips Global (TR-20200420-04-EN),  DigniCap Delta Training Tips TR-20191202-05-US,",
      "product_quantity": "499 dignicaps",
      "reason_for_recall": "Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions.",
      "recall_initiation_date": "20211105",
      "center_classification_date": "20220324",
      "termination_date": "20241029",
      "report_date": "20220330",
      "code_info": "All manufactured units lots/serial numbers: A65860-A73244"
    }
  ]
}