Reported Oct 15, 2025 · Ongoing
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Noxbox Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NOXBOX LTD · Unit 1 · Sittingbourne · N/A
Is this the product you have?
- NOxBOXi Nitric Oxide Delivery System
- Model NumbersNOXBOX-I
- Lot codes and dates
- Model Numbers
(1) NOXBOXI (NBL (Manufacturer))(2) REQNOXBOXI (Linde (U.S. Distributor))
- UDI-DI05060541640009; All serial numbers
- Model Numbers
- Amount recalled
- 1667 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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