NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System

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.

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: - Customers should ensure that all affected personnel are provided with a copy of the recommendations in this letter. - Users should avoid rapidly pressing buttons in quick succession (e.g., go to next screen, accept a value, change a value, backing out, repeating this) as it is necessary to allow an opportunity for the device to respond to user inputs before the next command to avoid a potential software interruption and subsequent restart. - NOxBOX Ltd. is asking customers in the U.S. to 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 be back in contact with you to update your device software. 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-0029-2026
• 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.