FDAFDA · Food and drugs·Recall number Z-3165-2026

NOxBOXi Nitric Oxide Delivery System.

Published September 23, 2026 · Recall initiated: August 19, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer: NOXBOX LTD
Distributor: US Nationwide distribution in the state of Georgia.
Lot: 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), NM100993 (NI100993), NM100994 (NI100994), NM100996 (NI100996), NM100997 (NI100997), NM100999 (NI100999), NM101001 (NI101001), NM101002 (NI101002), NM101003 (NI101003), NM101004 (NI101004), NM101005 (NI101005), NM101006 (NI101006), NM101008 (NI101008), NM101009 (NI101009), NM101010 (NI101010), NM101011 (NI101011), NM101012 (NI101012), NM101013 (NI101013), NM101014 (NI101014), NM101015 (NI101015), NM101017 (NI101017), NM101018 (NI101018), NM101019 (NI101019), NM101024 (NI101024), NM101026 (NI101026), NM101028 (NI101028), NM101029 (NI101029), NM101030 (NI101030), NM101031 (NI101031), NM101033 (NI101033), NM101034 (NI101034), NM101035 (NI101035), NM101038 (NI101038), NM101039 (NI101039), NM101041 (NI101041), NM101042 (NI101042), NM101044 (NI101044), NM101048 (NI101048), NM101049 (NI101049), NM101052 (NI101052), NM101057 (NI101057), NM101059 (NI101059), NM101060 (NI101060), NM101061 (NI101061), NM101063 (NI101063), NM101065 (NI101065), NM101067 (NI101067), NM101069 (NI101069), NM101071 (NI101071), NM101072 (NI101072), NM101073 (NI101073), NM101077 (NI101077), NM101079 (NI101079), NM101080 (NI101080), NM101081 (NI101081), NM101083 (NI101083), NM101084 (NI101084), NM101086 (NI101086), NM101088 (NI101088), NM101089 (NI101089), NM101090 (NI101090), NM101091 (NI101091), NM101092 (NI101092), NM101093 (NI101093), NM101094 (NI101094), NM101095 (NI101095), NM101099 (NI101099), NM101100 (NI101100), NM101101 (NI101101), NM101105 (NI101105), NM101106 (NI101106), NM101107 (NI101107), NM101108 (NI101108), NM101109 (NI101109), NM101110 (NI101110), NM101111 (NI101111), NM101112 (NI101112), NM101113 (NI101113), NM101114 (NI101114), NM101115 (NI101115), NM101116 (NI101116), NM101117 (NI101117), NM101125 (NI101125), NM101130 (NI101130), NM101131 (NI101131), NM101132 (NI101132), NM101133 (NI101133), NM101134 (NI101134), NM101135 (NI101135), NM101136 (NI101136), NM101137 (NI101137), NM101138 (NI101138), NM101141 (NI101141), NM101142 (NI101142), NM101144 (NI101144), NM101145 (NI101145), NM101146 (NI101146), NM101147 (NI101147), NM101148 (NI101148), NM101149 (NI101149), NM101150 (NI101150), NM101151 (NI101151), NM101153 (NI101153), NM101154 (NI101154), NM101155 (NI101155), NM101156 (NI101156), NM101158 (NI101158), NM101159 (NI101159), NM101160 (NI101160), NM101161 (NI101161), NM101162 (NI101162), NM101163 (NI101163), NM101164 (NI101164), NM101165 (NI101165), NM101167 (NI101167), NM101168 (NI101168), NM101170 (NI101170), NM101173 (NI101173), NM101174 (NI101174), NM101175 (NI101175), NM101176 (NI101176), NM101177 (NI101177), NM101178 (NI101178), NM101179 (NI101179), NM101180 (NI101180), NM101181 (NI101181), NM101182 (NI101182), NM101183 (NI101183), NM101184 (NI101184), NM101190 (NI101190), NM101191 (NI101191), NM101192 (NI101192), NM101199 (NI101199), NM101202 (NI101202), NM101204 (N
Risk classification: Class II
Area (FDA): device
Country: United Kingdom

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