{
  "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-1642-2023",
      "product_description": "Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass  Model                        Item No. VKMO 10000-USA      701070441 VKMO 11000-USA      701070445",
      "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 VKMO 10000-USA      701070441      4058863153841 VKMO 11000-USA      701070445      4058863153889 All lots"
    }
  ]
}