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U.S. Department of Health and Human Services

Class 1 Device Recall NOxBOXi Nitric Oxide Delivery System

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 Class 1 Device Recall NOxBOXi Nitric Oxide Delivery Systemsee related information
Date Initiated by FirmSeptember 09, 2025
Date PostedOctober 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0028-2026
Recall Event ID 97517
510(K)NumberK171696 K201339 K220898 K231823 K233251 
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
ProductNOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Code Information Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.
Recalling Firm/
Manufacturer		 NOXBOX LTD
Unit 1
Eurolink Gateway; Castle Road
Sittingbourne United Kingdom
For Additional Information ContactHeather Thomas
302-513-0898
Manufacturer 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).
FDA Determined
Cause 2		Software design
ActionOn 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.
Quantity in Commerce1667 units
DistributionDomestic: TN
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MRN
510(K)s with Product Code = MRN
510(K)s with Product Code = MRN
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