NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Reported: October 15, 2025 Initiated: September 9, 2025 #Z-0028-2026
Product Description
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Reason for Recall
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).
Details
- Recalling Firm
- NOXBOX LTD
- Units Affected
- 1667 units
- Distribution
- Domestic: TN
- Location
- Sittingbourne
Frequently Asked Questions
What product was recalled? ▼
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I. Recalled by NOXBOX LTD. Units affected: 1667 units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2025. Severity: Critical. Recall number: Z-0028-2026.
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