NOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
NOXBOX LTD is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems due to a manufacturing issue that may cause irregular oxygen readings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device that may provide inaccurate readings, posing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
NOXBOX LTD is recalling 1,667 units of the NOxBOXi Nitric Oxide Delivery System, Model Number NOXBOX-I. The recall is due to a manufacturing issue affecting certain oxygen sensors, which may result in irregular oxygen readings.
The affected units were distributed nationwide in the United States, specifically within the state of Georgia. The recall includes units with serial numbers listed in the official notice and oxygen sensor lots manufactured before April 13, 2026.
Consumers should check their device serial numbers against the list provided by the FDA or the manufacturer. If a device is affected, users should stop using it and contact NOXBOX LTD for instructions on repair or replacement.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
- Manufacturer
- NOXBOX LTD
- Affected units
- 1,667
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: NOXBOX-I. UDI-DI: 05060541640009. Serial Numbers: NI100825
- NI100833
- NI100839
- NI100840
- NI100841
- NI100847
- NI100848
- NI100849
- NI100850
- NI100851
- NI100852
- NI100855
- NI100858
- NI100859
- NI100861
- NI100862
- NI100865
- NI100866
- NI100868
- NI100869
Distribution
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