{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Madison",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69635",
      "recalling_firm": "INO Therapeutics (dba Ikaria)",
      "address_1": "2902 Dairy Dr",
      "address_2": "N/A",
      "postal_code": "53718-3809",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "US Distribution in states of: VA and PA only.",
      "recall_number": "Z-0575-2015",
      "product_description": "INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.",
      "product_quantity": "9",
      "reason_for_recall": "An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected.  This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.",
      "recall_initiation_date": "20141017",
      "center_classification_date": "20141209",
      "termination_date": "20150416",
      "report_date": "20141217",
      "code_info": "Serial Numbers:  DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169."
    }
  ]
}