NOXBOX LTD: Device Recall
Recall #Z-0028-2026 · 09/09/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-0028-2026
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- NOXBOX LTD
- Status
- Ongoing
- Date Initiated
- 09/09/2025
- Location
- Sittingbourne, United Kingdom
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1667 units
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).
Product Description
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Distribution Pattern
Domestic: TN
Other Recalls by NOXBOX LTD
- Class I: Dangerous 09/09/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.