{
  "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-1658-2023",
      "product_description": "QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass  Model                                       Item No. BEQ-HMOD30000-USA          701070397 BEQ-HMOD30000-USA          701050330",
      "product_quantity": "5,022 (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-HMOD30000-USA          701070397         4058863154435 BEQ-HMOD30000-USA          701050330         4037691670164   All lots"
    }
  ]
}