{
  "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-1643-2023",
      "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": "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 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"
    }
  ]
}