{
  "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": "92006",
      "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": "Nationwide domestic distribution",
      "recall_number": "Z-1657-2023",
      "product_description": "QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass  Model                                Item no. BEQ-HMO 50000-USA    701067905 HMO 50000-USA             701067891 HMO 51000-USA             701067895",
      "product_quantity": "1,784 (US)",
      "reason_for_recall": "Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.",
      "recall_initiation_date": "20230518",
      "center_classification_date": "20230530",
      "report_date": "20230607",
      "code_info": "Model                                Item no.           UDI-DI BEQ-HMO 50000-USA    701067905        4058863019079 HMO 50000-USA             701067891        4058863019055 HMO 51000-USA             701067895        4058863019185  All lots"
    }
  ]
}