{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Dexter",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "94016",
      "recalling_firm": "Mc3 Inc",
      "address_1": "2555 Bishop Cir W",
      "address_2": "",
      "postal_code": "48130-1563",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution.",
      "recall_number": "Z-1310-2024",
      "product_description": "NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature.  Product Number:  48135, 48135E",
      "product_quantity": "188 units",
      "reason_for_recall": "May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer",
      "recall_initiation_date": "20231011",
      "center_classification_date": "20240319",
      "report_date": "20240327",
      "code_info": "GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039",
      "more_code_info": ""
    }
  ]
}