Apparatus, Nitric Oxide Delivery

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-09-25Open, ClassifiedComponent design/selection

  NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.

  Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

• 2026-09-15Open, ClassifiedDevice Design

  NOxBOXi Nitric Oxide Delivery System.

  Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

• 2025-10-06Open, ClassifiedSoftware design

  NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

  Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

• 2025-10-06Open, ClassifiedSoftware design

  NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

  The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

• 2025-09-09Open, ClassifiedComponent design/selection

  NOxBOXi Nitric Oxide Delivery System

  Replacement of the internal Sample Pump due to high failure rates.

• 2023-12-15Open, ClassifiedProcess control

  VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for inhalation at the point of use

  Cassette did not meet an 1n-process flow criterion.

• 2023-06-09TerminatedComponent change control

  NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device

  Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

• 2022-09-13Open, ClassifiedUnder Investigation by firm

  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

  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.

• 2021-06-23TerminatedSoftware design

  GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860

  Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.

• 2015-02-27TerminatedProcess change control

  Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.

  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.