NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System

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).

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

On September 9, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: - Use the instructions provided to troubleshoot the device. - Complete and return the attached response form to Linde Gas & Equipment as instructed on the form. Recalling firm actions: NOxBOX Ltd. is in the process of developing a new software version that will include a modification to the software to resolve this issue, which will be released pending required regulatory review and approval. Once the software version is released, NOxBOX Ltd. will coordinate with Linde Gas & Equipment in the U.S. to update your device. If you have any questions about this notice or need assistance, please reach out to your local Clinical Educator or the Customer Excellence Center at 1-833-NOX-VENT (669-8368) or at LG.US.NOXIVENT@Linde.com.

• FDA enforcement recordOfficial FDA database entry for Z-0028-2026
• FDA 510(k) clearance · K171696The device's official FDA premarket clearance record
• FDA 510(k) clearance · K201339The device's official FDA premarket clearance record
• FDA 510(k) clearance · K220898The device's official FDA premarket clearance record
• FDA 510(k) clearance · K231823The device's official FDA premarket clearance record
• FDA 510(k) clearance · K233251The device's official FDA premarket clearance record
• FDA device classification · MRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5165The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find NOXBOX LTDSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.