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NOxBOXi Nitric Oxide Delivery System.

Class II
Recalling firm
NOXBOX LTD
Reason for recall
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Affected products (lot / model / serial)
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
Units affected
1,547 units
Distribution pattern
US Nationwide distribution in the state of Georgia.
Firm location
Sittingbourne, N/A, United Kingdom
Recall type
Voluntary: Firm initiated
How the firm notified customers
E-Mail
Product type
Devices
Status
Ongoing
Recall number
Z-3165-2026
Recall initiated
August 19, 2026
FDA classification date
September 15, 2026
FDA report date
September 23, 2026
FDA event ID
99621
Last updated on HTM Vibe
September 29, 2026
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