The FDA has posted 5 enforcement recalls of nitric oxide delivery apparatus devices since 2025, including 2 Class I (most serious) recalls. Most recent report: Oct 7, 2026.
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
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.…
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
Replacement of the internal Sample Pump due to high failure rates.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Apparatus, Nitric Oxide Delivery”). Informational only — verify against the FDA before acting.