{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Columbia",
      "address_1": "10480 Little Patuxent Pkwy",
      "reason_for_recall": "Distribution of an unapproved device into interstate commerce.",
      "address_2": "Suite 400",
      "product_quantity": "3 devices",
      "code_info": "Model 280, S/N 776, S/N 706, S/N 758",
      "center_classification_date": "20130418",
      "distribution_pattern": "Distributed in the states of Pennsylvania, Texas, and New York.",
      "state": "MD",
      "product_description": "Elana Catheter Sizer 2.0***    The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.",
      "report_date": "20130424",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Elana, Inc.",
      "recall_number": "Z-1143-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64538",
      "termination_date": "20130509",
      "recall_initiation_date": "20130214",
      "postal_code": "21044-3568",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}