{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Elkton",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91775",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "125 Blue Ball Rd",
      "address_2": "",
      "postal_code": "21921-5315",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.  Belgium, Canada, Costa Rica, Thailand.",
      "recall_number": "Z-1347-2023",
      "product_description": "CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC",
      "product_quantity": "4940 units",
      "reason_for_recall": "Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.",
      "recall_initiation_date": "20230301",
      "center_classification_date": "20230405",
      "report_date": "20230412",
      "code_info": "UDI-DI: (01)00699753450868; Lot Number AM03",
      "more_code_info": ""
    }
  ]
}