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Recall Observatory FDA recall evidence

Device product

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

Z-0028-2026

September 09, 2025

Class I

Product summary

Firm
NOXBOX LTD
Event
Event 97517
Status
Ongoing
Classification
Class I
Quantity
1667 units
Official record key
device-enforcement:Z-0028-2026

Official wording

Reason: 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).

Code information: Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.

Distribution pattern: Domestic: TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).