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

FDA device recall Z-0028-2026 · posted 2025-10-06 · Open, Classified

Recall details

Recalling firm

NOXBOX LTD

Reason for recall

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).

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

MRN

Quantity affected

1667 units

Distribution

Domestic: TN

Date initiated

2025-09-09

Date posted

2025-10-06

Location

Sittingbourne, United Kingdom

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