FDA
Food and Drug Administration · Recall Z-3165-2026 · Aug 19, 2026NOxBOXi Nitric Oxide Delivery System.
NOXBOX LTD
The hazard
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
NOxBOXi Nitric Oxide Delivery System.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model NM100833 (NI100833)Model NM100839 (NI100839)Model NM100840 (NI100840)Model NM100841 (NI100841)Model NM100847 (NI100847)Model NM100848 (NI100848)Model NM100849 (NI100849)Model NM100850 (NI100850)Model NM100851 (NI100851)Model NM100852 (NI100852)Model NM100855 (NI100855)Model NM100858 (NI100858)Model NM100859 (NI100859)Model NM100861 (NI100861)Model NM100862 (NI100862)Model NM100865 (NI100865)Model NM100866 (NI100866)Model NM100868 (NI100868)Model NM100869 (NI100869)Model NM100872 (NI100872)Model NM100873 (NI100873)Model NM100875 (NI100875)Model NM100876 (NI100876)Model NM100878 (NI100878)Model NM100879 (NI100879)UPC 05060541640009Would you have heard about this one?
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