{
  "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": [
    {
      "status": "Terminated",
      "city": "Kennesaw",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77728",
      "recalling_firm": "CryoLife, Inc.",
      "address_1": "1655 Roberts Blvd NW",
      "address_2": "N/A",
      "postal_code": "30144-3632",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to the state of : Illinois",
      "recall_number": "Z-3108-2017",
      "product_description": "On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use.    Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.",
      "product_quantity": "5 units",
      "reason_for_recall": "Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.",
      "recall_initiation_date": "20140212",
      "center_classification_date": "20170906",
      "termination_date": "20191105",
      "report_date": "20170913",
      "code_info": "Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902"
    }
  ]
}