Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) Recalled by Mallinckrodt, LLC. Due to The INOmax DSIR Delivery System, manufactured by Mallinckrodt...
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 Mallinckrodt, LLC. directly.
Affected Products
INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, Model Number: 10007
Quantity: 4,225 units OUS
Why Was This Recalled?
The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.
Where Was This Sold?
Foreign Only: Argentina Australia Austria Beligum Canada Chile Columbia Czech Republic Denmark Ecuador Estonia Finland France Germany Great Britain Hungary Iceland Ireland Italy Latvia Mexico Netherlands Norway Poland Portugal Romania Slovakia South Africa Spain Sweden Switzerland UAE Uruguay
About Mallinckrodt, LLC.
Mallinckrodt, LLC. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report