NOxBOXi Nitric Oxide Delivery System recallZ-0028-2026 · Noxbox Ltd · initiated Sep 9, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Noxbox Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Software design
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0028-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 9, 2025
- Posted by the FDA
- Oct 6, 2025
- Recalling firm
- Noxbox Ltd
- Quantity
- 1667 units
- Product code
- MRN
- FDA submissions
- K171696, K201339, K220898, K231823, K233251
- Distribution
- Domestic: TN
Product description
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Code information (models, lots, serial numbers)
Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NOxBOXi NOXBOX-INoxbox Ltd · Analyzer, Gas, Oxygen, Gaseous-Phase6 recalls5 deaths121 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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