Recall Z-3165-2026
Noxbox Ltd · initiated August 19, 2026
Product
NOxBOXi Nitric Oxide Delivery System.
Codes / lots: UDI-DI 05060541640009. Identification Number (Serial Number): NM100825 (NI100825), NM100833 (NI100833), NM100839 (NI100839), NM100840 (NI100840), NM100841 (NI100841), NM100847 (NI100847), NM100848 (NI100848), NM100849 (NI100849), NM100850 (NI100850), NM100851 (NI100851), NM100852 (NI100852), NM100855 (NI100855), NM100858 (NI100858), NM100859 (NI100859), NM100861 (NI100861), NM100862 (NI100862), NM100865 (NI100865), NM100866 (NI100866), NM100868 (NI100868), NM100869 (NI100869), NM100872 (NI100872), NM100873 (NI100873), NM100875 (NI100875), NM100876 (NI100876), NM100878 (NI100878), NM100879 (NI100879), NM100880 (NI100880), NM100881 (NI100881), NM100882 (NI100882), NM100883 (NI100883), NM100884 (NI100884), NM100885 (NI100885), NM100886 (NI100886), NM100887 (NI100887), NM100888 (NI100888), NM100895 (NI100895), NM100932 (NI100932), NM100935 (NI100935), NM100942 (NI100942), NM100948 (NI100948), NM100949 (NI100949), NM100953 (NI100953), NM100961 (NI100961), NM100975 (NI100975), NM100976 (NI100976), NM100978 (NI100978), NM100980 (NI100980), NM100983 (NI100983), NM100985 (NI100985), NM100986 (NI100986), NM100987 (NI100987), NM100989 (NI100989), NM100990 (NI100990), NM100991 (NI100991)…
Reason for recall
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
FDA-determined cause: Device Design
Action taken
NOxBOX notified its single US distributor on about 08/19/2026 via emailed "URGENT MEDICAL DEVICE CORRECTION" letter. Consignees were informed of the issue of potential oxygen leaks within the NOxMixer module of the NOxBOXi device due to failure of the tubing or tubing connection. This may lead to interruption in nitric oxide therapy, which could lead to oxygen desaturation and necessitate medical intervention. Distributors were instructed to examine inventory for affected units, complete and return the Distributor Response Form provided and NOxBOX will provide work instructions and material to complete the NOxMixer repairs. Before distributing any affected devices, perform all preventive maintenance checks on NOxBOXi devices. Those that have passed all preventive maintenance checks can continue to be distributed with a copy of this notice. Devices that do not pass must be quarantined until remediated. Distributors were also instructed to notify all affected customers and applicable personnel. Users of the device were instructed to examine inventory for affected, complete and return the Customer Response form provided, and provide the notification to all those who need to be made aware within the organization or to any organization where the potentially affected devices have been transferred or for which this action has an impact. Customers should ensure that all personnel using the device are provided with a copy of the recommendations in Attachment D and post them near the device. NOxBOX has developed a replacement for the tubing and tubing connection and will be working with distributors to implement for their affected devices. Further details will be provided to distributors to ensure all upgrades are successfully completed. In addition, NOxBOX is implementing an update to the NOxBOXi + NOxMixer Service Manual to include inspection of the NOxMixer internal oxygen tubing and tubing connection for replacement as part of the preventative maintenance (PM) sche
Details
- Recall number
- Z-3165-2026
- Initiated
- August 19, 2026
- Posted by FDA
- September 15, 2026
- Product code
- MRN – Apparatus, Nitric Oxide Delivery
- Quantity
- 1,547 units
- Distribution
- US Nationwide distribution in the state of Georgia.
- Recalling firm
- Noxbox Ltd, Sittingbourne