NOXBOX recalled 1,667 NOxBOXi Nitric Oxide Delivery System units sold in Tennessee. The recall was issued Sept. 9, 2025. An internal fault can occur when users press the interface rapidly without waiting for the device to respond. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
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
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The NOxBOXi Nitric Oxide Delivery System is used to deliver inhaled nitric oxide in clinical settings, supporting certain respiratory therapies.
The hazard arises from an internal fault triggered by rapid button presses, potentially leading to misoperation or diagnostic errors during use.
This recall is not identified as part of a broader industry pattern.
Immediate use restrictions may be necessary in clinical environments. Hospitals and patients may need to halt therapy until replacement guidance is provided.
Details are in the recall notice available from FDA enforcement pages and manufacturer communications
Refund or replacement processing typically 4-8 weeks after confirmation
Keep the recall notice, serial numbers, model numbers, photos of labeling, and correspondence with the manufacturer
Model numbers: NOXBOX-I, NBL, REQNOXBOXI, UDI-DI: 05060541640009 Where sold: Domestic, Tennessee (TN) When sold: Unknown Price: Unknown
No injuries or incidents have been reported.
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