This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

  • Product Names: NOxBOXi Nitric Oxide Delivery System
  • Unique Device Identifier (UDI): 05060541640009
  • Model: MOXBOXI (NBL Manufacturer), REQNOXBOXI (Linde U.S. Distributor)
  • Serial Numbers: All

What to Do  

Avoid rapidly pressing buttons in quick succession. Make sure all affected personnel are provided with the recommended actions provided by the firm.

On September 8, 2025, NOxBOX Ltd. sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

For customers

  • Ensure all affected personnel are provided with a copy of the recommendations included in the letter.
  • Customers in the U.S. should complete the form attached to the letter and return it to Linde Gas & Equipment.

For clinicians

  • Avoid rapidly pressing buttons in quick succession, as the device needs an opportunity to respond to user input before the next command is entered or it may experience a software interruption and unexpectedly shut down or restart. 
    • An example of a rapid sequence may be pushing buttons to advance to the next screen, accepting a value, changing a value, backing out of a screen or repeating entries.
  • In the event of an unexpected NOxBOXi system restart while interacting with the device on-screen prompts, the device will display a System Diagnostics notification. Note that there are other situations where a “System Diagnostics” notification might be issued by the device, and the following instructions will not resolve this error message.
    • To continue therapy, switch the device from Intelligent Mode to Manual Mode to deliver nitric oxide using the NOxMIXER.
    • Select the red on-screen Restart button.
    • Once the System restart has completed, Intelligent delivery may be resumed via the “Skip to Dose” function.

NOxBOX Ltd. is developing a new software version that will include a modification to the software to resolve this issue. Once the software version is released, NOxBOX Ltd. will contact customers to arrange for a software update.

Reason for Correction 

NOxBOX Ltd., a subsidiary of Linde Gas & Equipment Inc., is correcting NOxBOXi Nitric Oxide Delivery System to alert users of safety considerations associated with rapid button pushing on the NOxBOXi Nitric Oxide Delivery System. If users press two or more on-screen buttons in a rapid succession, it may trigger a software interruption and unexpected restart.

The use of affected product may cause serious adverse health consequences, including desaturation, increased artery pressure, therapy interruption, and death.  

As of September 9, 2025, NOxBOX Ltd has reported two serious injuries and no deaths associated with this issue.

Device Use

The NOxBOXi Nitric Oxide Delivery System is intended for the delivery and monitoring of a constant concentration of nitric oxide as well as monitoring of nitrogen dioxide and oxygen in the inspiratory ventilator lines of a patient undergoing inhaled nitric oxide therapy. 

Contact Information  

Customers in the U.S. with questions about this recall should contact their local clinical educator or the NOxBOX Customer Excellence Center at 1-833-NOX-VENT (669-8368) or LG.US.NOXIVENT@Linde.com.

Additional FDA Resources

Unique Device Identifier (UDI) 

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. 

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.