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

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

On about 08/31/2026 NOXBOX initially notified its single distributor of the recall via emailed URGENT MEDCIAL DEVICE CORRECTION letter. The letter instructed distributors to examine inventory for affected units, complete and return the provided Distributor Response Form, arrange for the replacement of affected oxygen sensors, perform all preventive maintenance checks on NOxBOXi devices prior to distribution of units, ensure all applicable personnel are notified within the organization, notify all customers who have received affected units. Device users were instructed to examine inventory for affected units, complete and return the provided Customer Response Form to their respective distributor, ensure all applicable personnel or organizations (if units were transferred) are notified within the organization, and ensure personnel using the device are made aware. NOxBOX is working with the oxygen sensor manufacturer to obtain replacement sensors for all affected devices and will coordinate with distributors to implement sensor replacement activities. As such, NOxBOX is asking distributors and customers to promptly return the Response Forms as instructed on the form to confirm the number devices still in service and the number of sensor replacements required.