{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Boulder",
      "address_1": "6135 Gunbarrel Ave",
      "reason_for_recall": "Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. This situation may potentially lead to respiratory compromise if not recognized.",
      "address_2": "",
      "product_quantity": "657 units",
      "code_info": "PB980 Ventilator (980xxxxxxxx): 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS",
      "center_classification_date": "20150814",
      "distribution_pattern": "Worldwide Distribution-US (nationwide) and the countries of  Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey, and Uruguay.",
      "state": "CO",
      "product_description": "Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models.    Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).",
      "report_date": "20150826",
      "classification": "Class I",
      "openfda": {},
      "recalling_firm": "Covidien LP (formerly Nellcor Puritan Bennett Inc.)",
      "recall_number": "Z-2329-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "71675",
      "termination_date": "20160602",
      "more_code_info": "",
      "recall_initiation_date": "20150716",
      "postal_code": "80301-3214",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}