{
  "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": "Wayne",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92003",
      "recalling_firm": "Maquet Medical Systems USA",
      "address_1": "45 Barbour Pond Dr",
      "address_2": "N/A",
      "postal_code": "07470-2094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic distribution nationwide.",
      "recall_number": "Z-1640-2023",
      "product_description": "QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass  Model                       Item no.  HMO 10000-USA    701070412 HMO 11000-USA    701070416",
      "product_quantity": "0 (US)",
      "reason_for_recall": "1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's  sterile pouch.  2. Product packaging may exhibit holes, cracks, dents, and crushed areas.     Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.",
      "recall_initiation_date": "20230518",
      "center_classification_date": "20230526",
      "report_date": "20230607",
      "code_info": "Model                       Item no.        UDI-DI HMO 10000-USA    701070412     4058863154473 HMO 11000-USA    701070416     4058863154558  All lots"
    }
  ]
}