Recall
FDAHealthSeptember 9, 2025

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

⚠️ 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).

Is this relevant to me?

Geography
TN
Source agency
FDA
Category
Health
Published
September 9, 2025

Domestic: TN

What's affected?

Product
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Lot code
Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.

Additional details

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

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 1667 units.

View original FDA notice →

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