Z-0028-2026Class I

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

Name: Z-0028-2026 NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Creator: Noxbox Ltd
Published: 2025-09-09
License: https://open.fda.gov/license/

Noxbox Limited / initiated 2025-09-09 / Open, Classified / root cause: software

FDA source

NOXBOX LTD began a recall of NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I on 2025-09-09. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0028-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-09-09
Posted: 2025-10-06
Recalling firm: Noxbox Limited
Product: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Product code: MRN Apparatus, Nitric Oxide Delivery
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).
Root cause tag: software
FDA root cause: Software design
Action: 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].
Quantity in commerce: 1667 units
Distribution: Domestic: TN
Product codes and lots: Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0028-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0028-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-06

Product code MRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)