NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Published October 15, 2025 · Recall initiated: September 9, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- NOXBOX LTD
- Distributor
- Domestic: TN
- Lot
- Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United Kingdom
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