{
  "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-1641-2023",
      "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": "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 30000-USA      701070384       4058863153681 HMO 31000-USA      701070388       4058863154299 All lots"
    }
  ]
}