{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "North Billerica",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "95042",
      "recalling_firm": "Breas Medical, Inc.",
      "address_1": "16 Esquire Rd",
      "address_2": "",
      "postal_code": "01862-2527",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "Z-2690-2024",
      "product_description": "Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)",
      "product_quantity": "8298",
      "reason_for_recall": "There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.",
      "recall_initiation_date": "20240725",
      "center_classification_date": "20240903",
      "report_date": "20240911",
      "code_info": "Model No 230000;  UDI-DI 07321822300004;  Lot Code: all lots up to 240530.",
      "more_code_info": ""
    }
  ]
}