{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Brooklyn Park",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97702",
      "recalling_firm": "Medtronic Perfusion Systems",
      "address_1": "7611 Northland Dr N",
      "address_2": "",
      "postal_code": "55428-1088",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US States: AZ, CA, TN",
      "recall_number": "Z-0487-2026",
      "product_description": "Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B",
      "product_quantity": "26 units",
      "reason_for_recall": "Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.",
      "recall_initiation_date": "20250912",
      "center_classification_date": "20251110",
      "report_date": "20251119",
      "code_info": "Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846",
      "more_code_info": ""
    }
  ]
}