{
  "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": "2026-04-22",
    "results": {
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  "results": [
    {
      "country": "United States",
      "city": "Gary",
      "address_1": "5700 W 23rd Ave",
      "reason_for_recall": "Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.",
      "address_2": "",
      "product_quantity": "1",
      "code_info": "GS025081",
      "center_classification_date": "20180209",
      "distribution_pattern": "International Distribution to:Germany",
      "state": "IN",
      "product_description": "Custom Made Tracheostomy Device    The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.",
      "report_date": "20180221",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "recall_number": "Z-0577-2018",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "79045",
      "termination_date": "20200424",
      "more_code_info": "",
      "recall_initiation_date": "20160715",
      "postal_code": "46406-2617",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}