Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
INOmax DSIR Recalled by INO Therapeutics (dba Ikaria) Due to An anomaly impacts the monitoring system of INOmax...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact INO Therapeutics (dba Ikaria) directly.
Affected Products
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
Quantity: 22
Why Was This Recalled?
An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater tha
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About INO Therapeutics (dba Ikaria)
INO Therapeutics (dba Ikaria) has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report