{
  "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-1662-2023",
      "product_description": "QUADROX-iR, used during cardiopulmonary bypass  Model                                    Item No.             Description BEQ-HMO 51100-USA         701067936         Small Adult with filter, with BIOLINE coating BEQ-HMO 71100-USA         701067880         Adult with filter, with BIOLINE Coating HMO 50100-USA                  701067934         Small Adult without filter, with SOFTLINE Coating HMO 51100-USA                  701067938         Small Adult with filter, with SOFTLINE Coating HMO 70100-USA                  701067874         Adult without filter, with SOFTLINE Coating HMO 71100-USA                  701067886         Adult with filter, with SOFTLINE Coating",
      "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 BEQ-HMO 51100-USA         701067936         N/A BEQ-HMO 71100-USA         701067880         4058863164052 HMO 50100-USA                  701067934         N/A HMO 51100-USA                  701067938         N/A HMO 70100-USA                  701067874         N/A HMO 71100-USA                  701067886         N/A  All lots"
    }
  ]
}