Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ikaria Recalled by INO Therapeutics (dba Ikaria) Due to Potential delivery failure alarm condition. INOmax DSIR with...
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
Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
Quantity: 45 units
Why Was This Recalled?
Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.
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