{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Arvada",
      "state": "CO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82365",
      "recalling_firm": "LivaNova USA Inc.",
      "address_1": "14401 W 65th Way",
      "address_2": "N/A",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Distribution to states of: IN, MO, and OH.",
      "recall_number": "Z-1099-2019",
      "product_description": "SORIN Heater-Cooler System 3T, REF 16-02-85    Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.",
      "product_quantity": "6 devices",
      "reason_for_recall": "For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).",
      "recall_initiation_date": "20180914",
      "center_classification_date": "20190405",
      "termination_date": "20220914",
      "report_date": "20190417",
      "code_info": "Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877."
    }
  ]
}