{
  "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": "Ann Arbor",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86779",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Rd",
      "address_2": "N/A",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide  Foreign: Belgium, India",
      "recall_number": "Z-0565-2021",
      "product_description": "(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC   modified to Advance, Sterile  Catalog Number: 3CX*FX25RWC    (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC   modified to Advance  Catalog Number: 3CX*FX25REC    CAPIOX FX25 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir-intended to be used to exchange gases between blood and a gaseous environment during cardiopulmonary bypass surgery.",
      "product_quantity": "5,079 Total: 523 US and 4,556 OUS",
      "reason_for_recall": "Capiox FX25 Advance oxygenator may be the incorrect configuration (East vs. West)",
      "recall_initiation_date": "20201111",
      "center_classification_date": "20201214",
      "termination_date": "20211122",
      "report_date": "20201223",
      "code_info": "(1) Lot Number: YD16  (2) Lot Number: YD23    Unit GTIN Code: (01)00699753450837"
    }
  ]
}