Official recall record

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

US FDA — Medical Devices · 2025-09-09 · United KingdomClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-09-09
Country of alert: United Kingdom
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 05060541640009
Brand on record: NOXBOX LTD

What the authority reported

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

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United Kingdom · all filters

Same barcode in other registries

The same EAN appears in 2 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2026-08-19 · US FDA — Medical Devices
NOxBOXi Nitric Oxide Delivery System.
2026-09-14 · US FDA — Medical Devices
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.