{
  "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": "Kennesaw",
      "state": "GA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82044",
      "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": "E-Mail",
      "distribution_pattern": "Worldwide Distribution - US Nationwide - Georgia and Germany.",
      "recall_number": "Z-1073-2019",
      "product_description": "On-X Aortic Heart Valve with Anatomic Sewing Ring    Product Usage:  The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X¿ Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.",
      "product_quantity": "2 devices",
      "reason_for_recall": "On-X Valve was mislabeled with the incorrect serial number.",
      "recall_initiation_date": "20190117",
      "center_classification_date": "20190328",
      "termination_date": "20200609",
      "report_date": "20190403",
      "code_info": "Model/Catalog Number ONXANE - 23,  Lot number 6827216, Expiration Date 11/19/2024"
    }
  ]
}