{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "country": "United States",
      "city": "Arvada",
      "address_1": "14401 W 65th Way",
      "reason_for_recall": "Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply.",
      "address_2": "",
      "product_quantity": "5264 Units Worldwide",
      "code_info": "Item No.: 48-30-00 Serial No: 28E24640, 28E24651, 28E24642, 28E24674, 28E24657, 28E24652, 28E24671, 28E24675, 28E24676, 28E24678, 28E24670    Item No 48-40-00 Serial No: 28E24644, 28E24641, 28E24648, 28E24661, 28E24643, 28E24650, 28E24677, 28E24659, 28E24658, 28E24672, 28E24666, 28E24660, 28E24665, 28E24645, 28E24646, 28E24667, 28E24668, 28E24669, 28E24679    Item No 48-50-00 Serial No: 28E24647, 28E24663, 28E24673, 28E24664    Item No 58-00-00 Serial No.: 28E24653, 28E24654, 28E24655, 28E24656",
      "center_classification_date": "20160921",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, FL, HI, KS, MA, NC, TX, UT and the countries of: Great Brittan, Peru, Russia, India, Hungary, Thailand, Germany, Azerbaijan, Austria, Italy, Slovakia, Bahrain, and Malaysia.",
      "state": "CO",
      "product_description": "St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console    Product Usage:  The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.",
      "report_date": "20160928",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Sorin Group USA, Inc.",
      "recall_number": "Z-2866-2016",
      "initial_firm_notification": "Telephone",
      "product_type": "Devices",
      "event_id": "75036",
      "termination_date": "20170526",
      "more_code_info": "",
      "recall_initiation_date": "20160825",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}