NOXBOX LTD recalled 1,667 NOxBOXi Nitric Oxide Delivery System units distributed in Tennessee after reports of flow and dose fluctuations. The device can show fluctuations when the total flow through its sensor drops below 0.5 LPM. Dose fluctuations have been observed with LifePulse HFJV or conventional ventilators under certain settings. Stop using the device immediately and follow the recall. NO
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).
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: E-Mail
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The NOxBOXi Nitric Oxide Delivery System is used to administer nitric oxide to patients requiring gas exchange support, typically in critical care settings.
If total sensor flow falls below 0.5 LPM, flow readings can be inaccurate, leading to dose fluctuations. Certain ventilator settings worsen this risk.
This recall is not described as part of a broader industry pattern.
Clinicians must monitor dosing accuracy and ensure device usage aligns with recall guidance to avoid potential patient harm.
FDA enforcement page and manufacturer recall notice.
Refund or replacement timelines are not specified. Hospitals should expect manufacturer updates and FDA guidance.
Keep recall notices, model numbers, UDI-DI, and correspondences with the manufacturer; photograph devices and serial numbers where possible.
Model numbers: NOXBOX-I, NBL, REQNOXBOXI. UDI-DI: 05060541640009. Sold in the United States, domestic distribution in Tennessee. Recall date: 2025-09-09. Report date: 2025-10-15. Units recalled: 1,667. Manufacturer: NOXBOX LTD.
No injuries or incidents have been reported.
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