NOXBOX recalled 1,667 Nitric Oxide Delivery Systems on September 9, 2025. The recall stems from dangerous dose fluctuations that could occur under specific device settings. Healthcare providers and patients should stop using the device immediately.
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
The recalled product is the NOxBOXi Nitric Oxide Delivery System, model number NOXBOX-I. It was distributed domestically in Tennessee.
Fluctuations may occur if the flow through the device sensor is less than 0.5 LPM. Dose fluctuations have been observed with specific settings on Bunnel LifePulse HFJV systems or conventional ventilators.
The recall is classified as Class I, indicating a high hazard level. There are no specific reports of injuries or incidents mentioned.
Stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact NOXBOX LTD or your healthcare provider for further guidance.
For questions, reach NOXBOX LTD via email or consult your healthcare provider. Further details are available on the FDA's website.
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