{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Irvine",
      "address_1": "1 Edwards Way",
      "reason_for_recall": "The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.",
      "address_2": "",
      "product_quantity": "32,145 units for all products in Recall Event",
      "code_info": "59194300, 59203362, 59216087, 59233785, 59243242",
      "center_classification_date": "20120812",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).",
      "state": "CA",
      "product_description": "Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7.    For use in patients who require hemodynamic monitoring.",
      "report_date": "20120822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Edwards Lifesciences, LLC",
      "recall_number": "Z-2193-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62278",
      "termination_date": "20140617",
      "more_code_info": "",
      "recall_initiation_date": "20120511",
      "postal_code": "92614-5688",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}