NOXBOX recalled 1,667 Nitric Oxide Delivery Systems on September 9, 2025. The recall follows reports of internal faults caused by rapid button selections. The company advises patients and healthcare providers to stop using the device immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact NOXBOX LTD or your healthcare provider for instructions. Notification method: Letter
The recalled product is the NOxBOXi Nitric Oxide Delivery System, Model Number NOXBOX-I. Approximately 1,667 units were distributed domestically in Tennessee.
The device can experience an internal fault or system diagnostic error when users rapidly press buttons without waiting for a response. This malfunction can pose significant risks to patients.
No incidents or injuries have been reported related to this recall. The product was classified as Class I, indicating a high hazard level.
Stop using the device immediately. Follow the manufacturer's recall instructions and contact NOXBOX LTD or your healthcare provider for further guidance.
For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0029-2026.
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