{
  "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-1655-2023",
      "product_description": "QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass  Model                                 Item No. HMO 30000-USA               701070384 HMO 31000-USA               701070388",
      "product_quantity": "0 (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 HMO 30000-USA               701070384               4058863153681 HMO 31000-USA               701070388               4058863154299  All lots"
    }
  ]
}