{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "204026",
      "product_res_number": "Z-0489-2024",
      "event_date_initiated": "2023-10-27",
      "event_date_posted": "2023-12-05",
      "recall_status": "Completed",
      "res_event_number": "93332",
      "product_code": "LSZ",
      "product_description": "vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)",
      "code_info": "UDI/DI 10190752155251:  Lot/serial numbers:  4022993, 4160569, 4160570, 4163199, 4163200, 4165472, 4166359, 4231715, 4243198, 4253792",
      "firm_fei_number": "3013421741",
      "recalling_firm": "Vyaire Medical",
      "address_1": "26125 N Riverwoods Blvd",
      "city": "Mettawa",
      "state": "IL",
      "postal_code": "60045-3420",
      "reason_for_recall": "Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.",
      "root_cause_description": "Process control",
      "action": "Vyaire issued a Customer Notification to its consignees on 10/27/2023 via email.  The notice  explained the issue and how to identify the affected products.  The firm is seeking the return of the circuits.",
      "product_quantity": "16 circuits",
      "distribution_pattern": "US:  Florida",
      "openfda": {
        "pma_number": [
          "P890057",
          "P890034",
          "P880013",
          "P850064"
        ],
        "device_name": "Ventilator, High Frequency",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
          "2021710",
          "3032745446",
          "8030673",
          "1220908",
          "1314417"
        ],
        "fei_number": [
          "2021710",
          "3032745446",
          "1220908",
          "1314417",
          "3004213967"
        ]
      }
    }
  ]
}