Class 2 Device Recall NOxBOXi Nitric Oxide Delivery System

• Date Initiated by Firm: August 19, 2026
• Date Posted: September 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3165-2026
• Recall Event ID: 99621
• 510(K)Number: K171696 K201339 K220898 K233251 K231823
• Product Classification: Apparatus, nitric oxide delivery - Product Code MRN
• Product: NOxBOXi Nitric Oxide Delivery System.
• Code Information: 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 (NI101204), NM101205 (NI101205), NM101207 (NI101207), NM101208 (NI101208), NM101209 (NI101209), NM101211 (NI101211), NM101212 (NI101212), NM101213 (NI101213), NM101214 (NI101214), NM101215 (NI101215), NM101216 (NI101216), NM101217 (NI101217), NM101218 (NI101218), NM101219 (NI101219), NM101220 (NI101220), NM101221 (NI101221), NM101222 (NI101222), NM101223 (NI101223), NM101224 (NI101224), NM101225 (NI101225), NM101227 (NI101227), NM101228 (NI101228), NM101229 (NI101229), NM101230 (NI101230), NM101231 (NI101231), NM101232 (NI101232), NM101233 (NI101233), NM101234 (NI101234), NM101236 (NI101236), NM101237 (NI101237), NM101241 (NI101241), NM101243 (NI101243), NM101244 (NI101244), NM101245 (NI101245), NM101246 (NI101246), NM101249 (NI101249), NM101250 (NI101250), NM101251 (NI101251), NM101252 (NI101252), NM101253 (NI101253), NM101254 (NI101254), NM101255 (NI101255), NM101256 (NI101256), NM101257 (NI101257), NM101258 (NI101258), NM101259 (NI101259), NM101263 (NI101263), NM101264 (NI101264), NM101265 (NI101265), NM101266 (NI101266), NM101268 (NI101268), NM101270 (NI101270), NM101271 (NI101271), NM101273 (NI101273), NM101278 (NI101278), NM101282 (NI101282), NM101284 (NI101284), NM101285 (NI101285), NM101286 (NI101286), NM101287 (NI101287), NM101288 (NI101288), NM101289 (NI101289), NM101292 (NI101292), NM101294 (NI101294), NM101295 (NI101295), NM101297 (NI101297), NM101298 (NI101298), NM101299 (NI101299), NM101300 (NI101300), NM101301 (NI101301), NM101303 (NI101303), NM101305 (NI101305), NM101307 (NI101307), NM101308 (NI101308), NM101309 (NI101309), NM101313 (NI101313), NM101314 (NI101314), NM101317 (NI101317), NM101321 (NI101321), NM101322 (NI101322), NM101323 (NI101323), NM101324 (NI101324), NM101326 (NI101326), NM101327 (NI101327), NM101328 (NI101328), NM101329 (NI101329), NM101330 (NI101330), NM101331 (NI101331), NM101333 (NI101333), NM101335 (NI101335), NM101336 (NI101336), NM101337 (NI101337), NM101338 (NI101338), NM101340 (NI101340), NM101342 (NI101342), NM101344 (NI101344), NM101346 (NI101346), NM101347 (NI101347), NM101349 (NI101349), NM101350 (NI101350), NM101351 (NI101351), NM101353 (NI101353), NM101354 (NI101354), NM101355 (NI101355), NM101356 (NI101356), NM101357 (NI101357), NM101359 (NI101359), NM101360 (NI101360), NM101361 (NI101361), NM101368 (NI101368), NM101372 (NI101372), NM101373 (NI101373), NM101376 (NI101376), NM101377 (NI101377), NM101379 (NI101379), NM101380 (NI101380), NM101381 (NI101381), NM101384 (NI101384), NM101386 (NI101386), NM101387 (NI101387), NM101388 (NI101388), NM101390 (NI101390), NM101392 (NI101392), NM101393 (NI101393), NM101394 (NI101394), NM101395 (NI101395), NM101396 (NI101396), NM101402 (NI101402), NM101404 (NI101404), NM101405 (NI101405), NM101406 (NI101406), NM101407 (NI101407), NM101408 (NI101408), NM101409 (NI101409), NM101410 (NI101410), NM101411 (NI101411), NM101412 (NI101412), NM101413 (NI101413), NM101414 (NI101414), NM101415 (NI101415), NM101416 (NI101416), NM101423 (NI101423), NM101425 (NI101425), NM101426 (NI101426), NM101428 (NI101428), NM101429 (NI101429), NM101430 (NI101430), NM101431 (NI101431), NM101432 (NI101432), NM101433 (NI101433), NM101434 (NI101434), NM101435 (NI101435), NM101436 (NI101436), NM101437 (NI101437), NM101439 (NI101439), NM101441 (NI101441), NM101442 (NI101442), NM101443 (NI101443), NM101444 (NI101444), NM101446 (NI101446), NM101448 (NI101448), NM101449 (NI101449), NM101451 (NI101451), NM101452 (NI101452), NM101454 (NI101454), NM101456 (NI101456), NM101457 (NI101457), NM101459 (NI101459), NM101460 (NI101460), NM101461 (NI101461), NM101462 (NI101462), NM101463 (NI101463), NM101464 (NI101464), NM101467 (NI101467), NM101468 (NI101468), NM101469 (NI101469), NM101472 (NI101472), NM101473 (NI101473), NM101474 (NI101474), NM101475 (NI101475), NM101478 (NI101478), NM101479 (NI101479), NM101482 (NI101482), NM101483 (NI101483), NM101484 (NI101484), NM101485 (NI101485), NM101486 (NI101486), NM101487 (NI101487), NM101489 (NI101489), NM101490 (NI101490), NM101491 (NI101491).NM101492 (NI101492), NM101496 (NI101496), NM101505 (NI101505), NM101506 (NI101506), NM101508 (NI101508), NM101509 (NI101509), NM101512 (NI101512), NM101514 (NI101514), NM101515 (NI101515), NM101516 (NI101516), NM101520 (NI101520), NM101521 (NI101521), NM101522 (NI101522), NM101524 (NI101524), NM101525 (NI101525), NM101526 (NI101526), NM101527 (NI101527), NM101529 (NI101529), NM101530 (NI101530), NM101532 (NI101532), NM101533 (NI101533), NM101540 (NI101540), NM101550 (NI101550), NM101551 (NI101551), NM101552 (NI101552), NM101553 (NI101553), NM101554 (NI101554), NM101557 (NI101557), NM101560 (NI101560), NM101563 (NI101563), NM101565 (NI101565), NM101566 (NI101566), NM101569 (NI101569), NM101570 (NI101570), NM101572 (NI101572), NM101573 (NI101573), NM101574 (NI101574), NM101575 (NI101575), NM101576 (NI101576), NM101577 (NI101577), NM101578 (NI101578), NM101579 (NI101579), NM101581 (NI101581), NM101584 (NI101584), NM101585 (NI101585), NM101588 (NI101588), NM101590 (NI101590), NM101591 (NI101591), NM101592 (NI101592), NM101593 (NI101593), NM101594 (NI101594), NM101595 (NI101595), NM101596 (NI101596), NM101597 (NI101597), NM101598 (NI101598), NM101599 (NI101599), NM101600 (NI101600), NM101601 (NI101601), NM101602 (NI101602), NM101604 (NI101604), NM101605 (NI101605), NM101606 (NI101606), NM101607 (NI101607), NM101608 (NI101608), NM101609 (NI101609), NM101610 (NI101610), NM101611 (NI101611), NM101612 (NI101612), NM101613 (NI101613), NM101614 (NI101614), NM101615 (NI101615), NM101616 (NI101616), NM101617 (NI101617), NM101620 (NI101620), NM101622 (NI101622), NM101623 (NI101623), NM101624 (NI101624), NM101625 (NI101625), NM101626 (NI101626), NM101627 (NI101627), NM101628 (NI101628), NM101629 (NI101629), NM101635 (NI101635), NM101636 (NI101636), NM101638 (NI101638), NM101639 (NI101639), NM101640 (NI101640), NM101641 (NI101641), NM101643 (NI101643), NM101644 (NI101644), NM101645 (NI101645), NM101651 (NI101651), NM101654 (NI101654), NM101655 (NI101655), NM101656 (NI101656), NM101657 (NI101657), NM101658 (NI101658), NM101659 (NI101659), NM101660 (NI101660), NM101662 (NI101662), NM101664 (NI101664), NM101665 (NI101665), NM101666 (NI101666), NM101667 (NI101667), NM101668 (NI101668), NM101669 (NI101669), NM101670 (NI101670), NM101671 (NI101671), NM101672 (NI101672), NM101674 (NI101674), NM101675 (NI101675), NM101676 (NI101676), NM101677 (NI101677), NM101678 (NI101678), NM101679 (NI101679), NM101680 (NI101680), NM101681 (NI101681), NM101682 (NI101682), NM101683 (NI101683), NM101684 (NI101684), NM101685 (NI101685), NM101686 (NI101686), NM101687 (NI101687), NM101688 (NI101688), NM101689 (NI101689), NM101690 (NI101690), NM101691 (NI101691), NM101692 (NI101692), NM101693 (NI101693), NM101694 (NI101694), NM101695 (NI101695), NM101696 (NI101696), NM101697 (NI101697), NM101699 (NI101699), NM101700 (NI101700), NM101703 (NI101703), NM101704 (NI101704), NM101705 (NI101705), NM101706 (NI101706), NM101707 (NI101707), NM101708 (NI101708), NM101709 (NI101709), NM101710 (NI101710), NM101711 (NI101711), NM101712 (NI101712), NM101713 (NI101713), NM101714 (NI101714), NM101715 (NI101715), NM101716 (NI101716), NM101717 (NI101717), NM101718 (NI101718), NM101719 (NI101719), NM101720 (NI101720), NM101721 (NI101721), NM101722 (NI101722), NM101723 (NI101723), NM101724 (NI101724), NM101726 (NI101726), NM101727 (NI101727), NM101729 (NI101729), NM101731 (NI101731), NM101732 (NI101732), NM101733 (NI101733), NM101735 (NI101735), NM101736 (NI101736), NM101737 (NI101737), NM101739 (NI101739), NM101740 (NI101740), NM101742 (NI101742), NM101743 (NI101743), NM101744 (NI101744), NM101746 (NI101746), NM101747 (NI101747), NM101748 (NI101748), NM101749 (NI101749), NM101750 (NI101750), NM101751 (NI101751), NM101753 (NI101753), NM101756 (NI101756), NM101759 (NI101759), NM101760 (NI101760), NM101761 (NI101761), NM101763 (NI101763), NM101765 (NI101765), NM101766 (NI101766), NM101767 (NI101767), NM101768 (NI101768), NM101769 (NI101769), NM101770 (NI101770), NM101771 (NI101771), NM101775 (NI101775), NM101776 (NI101776), NM101777 (NI101777), NM101778 (NI101778), NM101781 (NI101781), NM101782 (NI101782), NM101783 (NI101783), NM101784 (NI101784), NM101787 (NI101787), NM101791 (NI101791), NM101793 (NI101793), NM101794 (NI101794), NM101795 (NI101795), NM101796 (NI101796), NM101797 (NI101797), NM101798 (NI101798), NM101799 (NI101799), NM101804 (NI101804), NM101805 (NI101805), NM101806 (NI101806), NM101807 (NI101807), NM101808 (NI101808), NM101809 (NI101809), NM101810 (NI101810), NM101811 (NI101811), NM101812 (NI101812), NM101813 (NI101813), NM101814 (NI101814), NM101815 (NI101815), NM101816 (NI101816), NM101817 (NI101817), NM101818 (NI101818), NM101819 (NI101819), NM101820 (NI101820), NM101821 (NI101821), NM101822 (NI101822), NM101823 (NI101823), NM101824 (NI101824), NM101825 (NI101825), NM101826 (NI101826), NM101828 (NI101828), NM101829 (NI101829), NM101831 (NI101831), NM101832 (NI101832), NM101834 (NI101834), NM101835 (NI101835), NM101836 (NI101836), NM101837 (NI101837), NM101838 (NI101838), NM101840 (NI101840), NM101841 (NI101841), NM101842 (NI101842), NM101843 (NI101843), NM101844 (NI101844), NM101845 (NI101845), NM101846 (NI101846), NM101848 (NI101848), NM101849 (NI101849), NM101851 (NI101851), NM101854 (NI101854), NM101857 (NI101857), NM101859 (NI101859), NM101861 (NI101861), NM101862 (NI101862), NM101864 (NI101864), NM101865 (NI101865), NM101867 (NI101867), NM101868 (NI101868), NM101869 (NI101869), NM101872 (NI101872), NM101873 (NI101873), NM101874 (NI101874), NM101875 (NI101875), NM101876 (NI101876), NM101878 (NI101878), NM101879 (NI101879), NM101880 (NI101880), NM101881 (NI101881), NM101882 (NI101882), NM101883 (NI101883), NM101884 (NI101884), NM101885 (NI101885), NM101886 (NI101886), NM101887 (NI101887), NM101889 (NI101889), NM101890 (NI101890), NM101891 (NI101891), NM101892 (NI101892), NM101895 (NI101895), NM101896 (NI101896), NM101898 (NI101898), NM101899 (NI101899), NM101901 (NI101901), NM101902 (NI101902), NM101903 (NI101903), NM101904 (NI101904), NM101905 (NI101905), NM101906 (NI101906), NM101907 (NI101907), NM101908 (NI101908), NM101909 (NI101909), NM101910 (NI101910), NM101912 (NI101912), NM101913 (NI101913), NM101914 (NI101914), NM101916 (NI101916), NM101919 (NI101919), NM101920 (NI101920), NM101922 (NI101922), NM101924 (NI101924), NM101925 (NI101925), NM101926 (NI101926), NM101928 (NI101928), NM101936 (NI101936), NM101937 (NI101937), NM101939 (NI101939), NM101940 (NI101940), NM101941 (NI101941), NM101942 (NI101942), NM101943 (NI101943), NM101944 (NI101944), NM101945 (NI101945), NM101946 (NI101946), NM101947 (NI101947), NM101948 (NI101948), NM101952 (NI101952), NM101953 (NI101953), NM101954 (NI101954), NM101955 (NI101955), NM101956 (NI101956), NM101957 (NI101957), NM101958 (NI101958), NM101959 (NI101959), NM101960 (NI101960), NM101961 (NI101961), NM101962 (NI101962), NM101963 (NI101963), NM101964 (NI101964), NM101965 (NI101965), NM101966 (NI101966), NM101967 (NI101967), NM101968 (NI101968), NM101970 (NI101970), NM101971 (NI101971), NM101972 (NI101972), NM101973 (NI101973), NM101974 (NI101974), NM101975 (NI101975), NM101976 (NI101976), NM101977 (NI101977), NM101978 (NI101978), NM101979 (NI101979), NM101981 (NI101981), NM101982 (NI101982), NM101983 (NI101983), NM101984 (NI101984), NM101985 (NI101985), NM101986 (NI101986), NM101987 (NI101987), NM101988 (NI101988), NM101989 (NI101989), NM101990 (NI101990), NM101991 (NI101991), NM101992 (NI101992), NM101993 (NI101993), NM101994 (NI101994), NM101995 (NI101995), NM101996 (NI101996), NM101997 (NI101997), NM101998 (NI101998), NM101999 (NI101999), NM102000 (NI102000), NM102001 (NI102001), NM102002 (NI102002), NM102003 (NI102003), NM102004 (NI102004), NM102006 (NI102006), NM102007 (NI102007), NM102008 (NI102008), NM102009 (NI102009), NM102010 (NI102010), NM102011 (NI102011), NM102012 (NI102012), NM102013 (NI102013), NM102014 (NI102014), NM102015 (NI102015), NM102017 (NI102017), NM102018 (NI102018), NM102019 (NI102019), NM102020 (NI102020), NM102021 (NI102021), NM102023 (NI102023), NM102024 (NI102024), NM102025 (NI102025), NM102026 (NI102026), NM102027 (NI102027), NM102028 (NI102028), NM102031 (NI102031), NM102032 (NI102032), NM102033 (NI102033), NM102035 (NI102035), NM102036 (NI102036), NM102037 (NI102037), NM102038 (NI102038), NM102040 (NI102040), NM102043 (NI102043), NM102044 (NI102044), NM102045 (NI102045), NM102046 (NI102046), NM102047 (NI102047), NM102048 (NI102048), NM102049 (NI102049), NM102051 (NI102051), NM102052 (NI102052), NM102053 (NI102053), NM102055 (NI102055), NM102056 (NI102056), NM102057 (NI102057), NM102059 (NI102059), NM102060 (NI102060), NM102061 (NI102061), NM102062 (NI102062), NM102063 (NI102063), NM102065 (NI102065), NM102067 (NI102067), NM102068 (NI102068), NM102069 (NI102069), NM102070 (NI102070), NM102071 (NI102071), NM102072 (NI102072), NM102074 (NI102074), NM102075 (NI102075), NM102076 (NI102076), NM102077 (NI102077), NM102078 (NI102078), NM102079 (NI102079), NM102081 (NI102081), NM102082 (NI102082), NM102083 (NI102083), NM102086 (NI102086), NM102089 (NI102089), NM102090 (NI102090), NM102091 (NI102091), NM102092 (NI102092), NM102093 (NI102093), NM102094 (NI102094), NM102095 (NI102095), NM102096 (NI102096), NM102097 (NI102097), NM102098 (NI102098), NM102099 (NI102099), NM102102 (NI102102), NM102103 (NI102103), NM102104 (NI102104), NM102105 (NI102105), NM102106 (NI102106), NM102107 (NI102107), NM102108 (NI102108), NM102109 (NI102109), NM102110 (NI102110), NM102111 (NI102111), NM102113 (NI102113), NM102114 (NI102114), NM102115 (NI102115), NM102116 (NI102116), NM102117 (NI102117), NM102118 (NI102118), NM102119 (NI102119), NM102120 (NI102120), NM102121 (NI102121), NM102123 (NI102123), NM102124 (NI102124), NM102125 (NI102125), NM102126 (NI102126), NM102127 (NI102127), NM102128 (NI102128), NM102129 (NI102129), NM102131 (NI102131), NM102132 (NI102132), NM102133 (NI102133), NM102134 (NI102134), NM102135 (NI102135), NM102136 (NI102136), NM102137 (NI102137), NM102138 (NI102138), NM102139 (NI102139), NM102140 (NI102140), NM102141 (NI102141), NM102142 (NI102142), NM102144 (NI102144), NM102145 (NI102145), NM102146 (NI102146), NM102147 (NI102147), NM102148 (NI102148), NM102149 (NI102149), NM102150 (NI102150), NM102152 (NI102152), NM102155 (NI102155), NM102160 (NI102160), NM102161 (NI102161), NM102163 (NI102163), NM102164 (NI102164), NM102165 (NI102165), NM102166 (NI102166), NM102167 (NI102167), NM102168 (NI102168), NM102169 (NI102169), NM102170 (NI102170), NM102171 (NI102171), NM102172 (NI102172), NM102173 (NI102173), NM102174 (NI102174), NM102175 (NI102175), NM102176 (NI102176), NM102177 (NI102177), NM102180 (NI102180), NM102182 (NI102182), NM102183 (NI102183), NM102184 (NI102184), NM102186 (NI102186), NM102188 (NI102188), NM102189 (NI102189), NM102190 (NI102190), NM102191 (NI102191), NM102192 (NI102192), NM102193 (NI102193), NM102194 (NI102194), NM102195 (NI102195), NM102196 (NI102196), NM102197 (NI102197), NM102198 (NI102198), NM102199 (NI102199), NM102200 (NI102200), NM102205 (NI102205), NM102206 (NI102206), NM102208 (NI102208), NM102209 (NI102209), NM102212 (NI102212), NM102213 (NI102213), NM102214 (NI102214), NM102215 (NI102215), NM102216 (NI102216), NM102219 (NI102219), NM102221 (NI102221), NM102222 (NI102222), NM102226 (NI102226), NM102227 (NI102227), NM102228 (NI102228), NM102230 (NI102230), NM102231 (NI102231), NM102232 (NI102232), NM102233 (NI102233), NM102234 (NI102234), NM102235 (NI102235), NM102237 (NI102237), NM102238 (NI102238), NM102239 (NI102239), NM102240 (NI102240), NM102241 (NI102241), NM102244 (NI102244), NM102245 (NI102245), NM102246 (NI102246), NM102247 (NI102247), NM102249 (NI102249), NM102250 (NI102250), NM102253 (NI102253), NM102254 (NI102254), NM102255 (NI102255), NM102256 (NI102256), NM102259 (NI102259), NM102263 (NI102263), NM102265 (NI102265), NM102266 (NI102266), NM102268 (NI102268), NM102269 (NI102269), NM102270 (NI102270), NM102271 (NI102271), NM102272 (NI102272), NM102273 (NI102273), NM102274 (NI102274), NM102275 (NI102275), NM102276 (NI102276), NM102277 (NI102277), NM102278 (NI102278), NM102279 (NI102279), NM102280 (NI102280), NM102281 (NI102281), NM102282 (NI102282), NM102283 (NI102283), NM102284 (NI102284), NM102285 (NI102285), NM102286 (NI102286), NM102287 (NI102287), NM102288 (NI102288), NM102290 (NI102290), NM102291 (NI102291), NM102292 (NI102292), NM102293 (NI102293), NM102295 (NI102295), NM102296 (NI102296), NM102297 (NI102297), NM102298 (NI102298), NM102299 (NI102299), NM102300 (NI102300), NM102304 (NI102304), NM102305 (NI102305), NM102306 (NI102306), NM102307 (NI102307), NM102308 (NI102308), NM102309 (NI102309), NM102310 (NI102310), NM102311 (NI102311), NM102327 (NI102327), NM102329 (NI102329), NM102330 (NI102330), NM102331 (NI102331), NM102332 (NI102332), NM102338 (NI102338), NM102339 (NI102339), NM102340 (NI102340), NM102341 (NI102341), NM102342 (NI102342), NM102343 (NI102343), NM102345 (NI102345), NM102346 (NI102346), NM102347 (NI102347), NM102349 (NI102349), NM102350 (NI102350), NM102351 (NI102351), NM102355 (NI102355), NM102356 (NI102356), NM102357 (NI102357), NM102358 (NI102358), NM102359 (NI102359), NM102360 (NI102360), NM102361 (NI102361), NM102362 (NI102362), NM102363 (NI102363), NM102364 (NI102364), NM102366 (NI102366), NM102377 (NI102377), NM102380 (NI102380), NM102381 (NI102381), NM102383 (NI102383), NM102384 (NI102384), NM102385 (NI102385), NM102387 (NI102387), NM102389 (NI102389), NM102390 (NI102390), NM102391 (NI102391), NM102392 (NI102392), NM102393 (NI102393), NM102394 (NI102394), NM102395 (NI102395), NM102396 (NI102396), NM102397 (NI102397), NM102398 (NI102398), NM102399 (NI102399), NM102400 (NI102400), NM102402 (NI102402), NM102403 (NI102403), NM102404 (NI102404), NM102405 (NI102405), NM102406 (NI102406), NM102407 (NI102407), NM102408 (NI102408), NM102410 (NI102410), NM102411 (NI102411), NM102413 (NI102413), NM102414 (NI102414), NM102415 (NI102415), NM102417 (NI102417), NM102418 (NI102418), NM102422 (NI102422), NM102423 (NI102423), NM102424 (NI102424), NM102425 (NI102425), NM102426 (NI102426), NM102427 (NI102427), NM102428 (NI102428), NM102429 (NI102429), NM102431 (NI102431), NM102432 (NI102432), NM102433 (NI102433), NM102434 (NI102434), NM102435 (NI102435), NM102436 (NI102436), NM102437 (NI102437), NM102438 (NI102438), NM102444 (NI102444), NM102445 (NI102445), NM102447 (NI102447), NM102463 (NI102463), NM102466 (NI102466), NM102467 (NI102467), NM102472 (NI102472), NM102473 (NI102473), NM102474 (NI102474), NM102475 (NI102475), NM102476 (NI102476), NM102477 (NI102477), NM102478 (NI102478), NM102479 (NI102479), NM102480 (NI102480), NM102481 (NI102481), NM102482 (NI102482), NM102483 (NI102483), NM102484 (NI102484), NM102485 (NI102485), NM102486 (NI102486), NM102487 (NI102487), NM102488 (NI102488), NM102489 (NI102489), NM102490 (NI102490), NM102492 (NI102492), NM102494 (NI102494), NM102495 (NI102495), NM102496 (NI102496), NM102497 (NI102497), NM102498 (NI102498), NM102499 (NI102499), NM102500 (NI102500), NM102501 (NI102501), NM102502 (NI102502), NM102503 (NI102503), NM102504 (NI102504), NM102506 (NI102506), NM102507 (NI102507), NM102509 (NI102509), NM102510 (NI102510), NM102511 (NI102511), NM102512 (NI102512), NM102513 (NI102513), NM102517 (NI102517), NM102518 (NI102518), NM102519 (NI102519), NM102520 (NI102520), NM102522 (NI102522), NM102525 (NI102525), NM102528 (NI102528), NM102530 (NI102530), NM102531 (NI102531), NM102535 (NI102535), NM102536 (NI102536), NM102537 (NI102537), NM102538 (NI102538), NM102539 (NI102539), NM102540 (NI102540), NM102541 (NI102541), NM102542 (NI102542), NM102543 (NI102543), NM102544 (NI102544), NM102545 (NI102545), NM102546 (NI102546), NM102547 (NI102547), NM102548 (NI102548), NM102550 (NI102550), NM102551 (NI102551), NM102552 (NI102552), NM102553 (NI102553), NM102554 (NI102554), NM102555 (NI102555), NM102556 (NI102556), NM102557 (NI102557), NM102558 (NI102558), NM102560 (NI102560), NM102561 (NI102561), NM102562 (NI102562), NM102563 (NI102563), NM102564 (NI102564), NM102565 (NI102565), NM102566 (NI102566), NM102567 (NI102567), NM102568 (NI102568), NM102569 (NI102569), NM102570 (NI102570), NM102571 (NI102571), NM102574 (NI102574), NM102575 (NI102575), NM102576 (NI102576), NM102577 (NI102577), NM102578 (NI102578), NM102579 (NI102579), NM102580 (NI102580), NM102581 (NI102581), NM102582 (NI102582), NM102583 (NI102583), NM102584 (NI102584), NM102585 (NI102585), NM102586 (NI102586), NM102587 (NI102587), NM102588 (NI102588), NM102590 (NI102590), NM102591 (NI102591), NM102592 (NI102592), NM102593 (NI102593), NM102594 (NI102594), NM102595 (NI102595), NM102596 (NI102596), NM102597 (NI102597), NM102598 (NI102598), NM102599 (NI102599), NM102600 (NI102600), NM102601 (NI102601), NM102602 (NI102602), NM102604 (NI102604), NM102605 (NI102605), NM102606 (NI102606), NM102607 (NI102607), NM102608 (NI102608), NM102610 (NI102610), NM102611 (NI102611), NM102613 (NI102613), NM102614 (NI102614), NM102615 (NI102615), NM102616 (NI102616), NM102617 (NI102617), NM102618 (NI102618), NM102619 (NI102619), NM102620 (NI102620), NM102621 (NI102621), NM102622 (NI102622), NM102623 (NI102623), NM102624 (NI102624), NM102625 (NI102625), NM102627 (NI102627), NM102628 (NI102628), NM102629 (NI102629), NM102630 (NI102630), NM102631 (NI102631), NM102632 (NI102632), NM102634 (NI102634), NM102635 (NI102635), NM102637 (NI102637), NM102638 (NI102638), NM102639 (NI102639), NM102640 (NI102640), NM102641 (NI102641), NM102642 (NI102642), NM102643 (NI102643), NM102645 (NI102645), NM102647 (NI102647), NM102648 (NI102648), NM102649 (NI102649), NM102651 (NI102651), NM102652 (NI102652), NM102653 (NI102653), NM102655 (NI102655), NM102656 (NI102656), NM102657 (NI102657), NM102658 (NI102658), NM102659 (NI102659), NM102660 (NI102660), NM102661 (NI102661), NM102662 (NI102662), NM102663 (NI102663), NM102664 (NI102664), NM102665 (NI102665), NM102666 (NI102666), NM102667 (NI102667), NM102668 (NI102668), NM102669 (NI102669), NM102670 (NI102670), NM102671 (NI102671), NM102672 (NI102672), NM102673 (NI102673), NM102674 (NI102674), NM102675 (NI102675), NM102676 (NI102676), NM102680 (NI102680), NM102681 (NI102681), NM102683 (NI102683), NM102684 (NI102684), NM102685 (NI102685), NM102686 (NI102686), NM102687 (NI102687), NM102688 (NI102688), NM102689 (NI102689), NM102691 (NI102691), NM102692 (NI102692), NM102693 (NI102693), NM102695 (NI102695), NM102696 (NI102696), NM102697 (NI102697), NM102698 (NI102698), NM102699 (NI102699), NM102700 (NI102700), NM102701 (NI102701), NM102702 (NI102702), NM102703 (NI102703), NM102704 (NI102704), NM102705 (NI102705), NM102706 (NI102706), NM102707 (NI102707), NM102708 (NI102708), NM102709 (NI102709), NM102710 (NI102710), NM102711 (NI102711), NM102713 (NI102713), NM102714 (NI102714), NM102715 (NI102715), NM102717 (NI102717), NM102720 (NI102720), NM102722 (NI102722), NM102724 (NI102724), NM102725 (NI102725), NM102726 (NI102726), NM102727 (NI102727), NM102728 (NI102728), NM102729 (NI102729), NM102730 (NI102730), NM102731 (NI102731), NM102732 (NI102732), NM102733 (NI102733), NM102734 (NI102734), NM102735 (NI102735), NM102736 (NI102736), NM102737 (NI102737), NM102738 (NI102738), NM102739 (NI102739), NM102740 (NI102740), NM102741 (NI102741), NM102742 (NI102742), NM102743 (NI102743), NM102744 (NI102744), NM102745 (NI102745), NM102746 (NI102746), NM102747 (NI102747), NM102748 (NI102748), NM102751 (NI102751), NM102752 (NI102752), NM102753 (NI102753), NM102755 (NI102755), NM102756 (NI102756), NM102757 (NI102757), NM102758 (NI102758), NM102759 (NI102759), NM102760 (NI102760), NM102762 (NI102762), NM102763 (NI102763), NM102764 (NI102764), NM102765 (NI102765), NM102766 (NI102766), NM102767 (NI102767), NM102768 (NI102768), NM102769 (NI102769), NM102770 (NI102770), NM102771 (NI102771), NM102772 (NI102772), NM102773 (NI102773), NM102774 (NI102774), NM102776 (NI102776), NM102777 (NI102777), NM102778 (NI102778), NM102781 (NI102781), NM102783 (NI102783), NM102784 (NI102784), NM102785 (NI102785), NM102786 (NI102786), NM102789 (NI102789), NM102790 (NI102790), NM102791 (NI102791), NM102792 (NI102792), NM102793 (NI102793), NM102794 (NI102794), NM102795 (NI102795), NM102798 (NI102798), NM102799 (NI102799), NM102800 (NI102800), NM102801 (NI102801), NM102802 (NI102802), NM102803 (NI102803), NM102804 (NI102804), NM102805 (NI102805), NM102806 (NI102806), NM102807 (NI102807), NM102808 (NI102808), NM102809 (NI102809), NM102810 (NI102810), NM102811 (NI102811), NM102812 (NI102812), NM102813 (NI102813), NM102814 (NI102814), NM102815 (NI102815), NM102816 (NI102816), NM102817 (NI102817), NM102818 (NI102818), NM102819 (NI102819), NM102821 (NI102821), NM102823 (NI102823), NM102824 (NI102824), NM102825 (NI102825), NM102828 (NI102828), NM102830 (NI102830), NM102832 (NI102832), NM102833 (NI102833), NM102834 (NI102834), NM102836 (NI102836), NM102837 (NI102837), NM102838 (NI102838), NM102839 (NI102839), NM102840 (NI102840), NM102841 (NI102841), NM102842 (NI102842), NM102843 (NI102843), NM102844 (NI102844), NM102845 (NI102845), NM102846 (NI102846), NM102847 (NI102847), NM102848 (NI102848), NM102849 (NI102849), NM102850 (NI102850), NM102851 (NI102851), NM102852 (NI102852), NM102853 (NI102853), NM102854 (NI102854), NM102855 (NI102855), NM102856 (NI102856), NM102858 (NI102858), NM102859 (NI102859), NM102860 (NI102860), NM102861 (NI102861), NM102862 (NI102862), NM102863 (NI102863), NM102865 (NI102865), NM102866 (NI102866), NM102868 (NI102868), NM102870 (NI102870), NM102871 (NI102871), NM102872 (NI102872), NM102873 (NI102873), NM102874 (NI102874), NM102876 (NI102876), NM102877 (NI102877), NM102878 (NI102878), NM102879 (NI102879), NM102880 (NI102880), NM102881 (NI102881), NM102882 (NI102882), NM102883 (NI102883), NM102884 (NI102884), NM102885 (NI102885), NM102886 (NI102886), NM102887 (NI102887), NM102888 (NI102888), NM102889 (NI102889), NM102890 (NI102890), NM102891 (NI102891), NM102892 (NI102892), NM102893 (NI102893), NM102894 (NI102894), NM102897 (NI102897), NM102898 (NI102898), NM102899 (NI102899), NM102900 (NI102900), NM102901 (NI102901), NM102902 (NI102902), NM102904 (NI102904), NM102905 (NI102905), NM102906 (NI102906), NM102907 (NI102907), NM102908 (NI102908), NM102910 (NI102910), NM102911 (NI102911), NM102913 (NI102913), NM102914 (NI102914), NM102915 (NI102915), NM102916 (NI102916), NM102917 (NI102917), NM102918 (NI102918), NM102919 (NI102919), NM102920 (NI102920), NM102921 (NI102921), NM102922 (NI102922), NM102923 (NI102923), NM102926 (NI102926), NM102927 (NI102927), NM102928 (NI102928), NM102929 (NI102929), NM102930 (NI102930), NM102931 (NI102931), NM102932 (NI102932), NM102933 (NI102933), NM102934 (NI102934), NM102935 (NI102935), NM102936 (NI102936), NM102937 (NI102937), NM102939 (NI102939), NM102942 (NI102942), NM102944 (NI102944), NM102947 (NI102947), NM102950 (NI102950), NM102955 (NI102955), NM102957 (NI102957), NM102958 (NI102958), NM102961 (NI102961), NM102962 (NI102962), NM102963 (NI102963), NM102964 (NI102964), NM102966 (NI102966), NM102967 (NI102967), NM102968 (NI102968), NM102970 (NI102970), NM102973 (NI102973), NM102977 (NI102977), NM102979 (NI102979), NM102986 (NI102986), NM102987 (NI102987), NM102989 (NI102989), NM102990 (NI102990), NM102991 (NI102991), NM102992 (NI102992), NM102996 (NI102996), NM102997 (NI102997), NM102998 (NI102998), NM102999 (NI102999), NM103001 (NI103001), NM103002 (NI103002), NM103003 (NI103003), NM103007 (NI103007), NM103011 (NI103011), NM103012 (NI103012), NM103014 (NI103014), NM103016 (NI103016), NM103017 (NI103017), NM103018 (NI103018), NM103019 (NI103019), NM103020 (NI103020), NM103021 (NI103021), NM103022 (NI103022), NM103023 (NI103023), NM103024 (NI103024), NM103074 (NI103074), NM103079 (NI103079), NM103082 (NI103082), NM103083 (NI103083), NM103084 (NI103084), NM103085 (NI103085), NM103087 (NI103087), NM103088 (NI103088), NM103089 (NI103089), NM103091 (NI103091), NM103093 (NI103093), NM103094 (NI103094), NM103095 (NI103095), NM103104 (NI103104), NM103116 (NI103116), NM103117 (NI103117), NM103120 (NI103120), NM103122 (NI103122), NM103123 (NI103123), NM103126 (NI103126), NM103127 (NI103127), NM103131 (NI103131), NM103136 (NI103136), NM103139 (NI103139), NM103144 (NI103144), NM103145 (NI103145), NM103146 (NI103146), NM103147 (NI103147), NM103148 (NI103148), NM103151 (NI103151), NM103152 (NI103152), NM103153 (NI103153), NM103155 (NI103155), NM103157 (NI103157), NM103159 (NI103159), NM103168 (NI103168), NM103170 (NI103170), NM103181 (NI103181), NM103182 (NI103182), NM103183 (NI103183), NM103189 (NI103189), NM103196 (NI103196), NM103203 (NI103203), NM103204 (NI103204), NM103208 (NI103208), NM103215 (NI103215), NM103220 (NI103220).
• FEI Number: 3012796317
• Recalling Firm/ Manufacturer: NOXBOX LTD; Unit 1; Eurolink Gateway; Castle Road; Sittingbourne United Kingdom
• Manufacturer 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: 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
• Quantity in Commerce: 1,547 units
• Distribution: US Nationwide distribution in the state of Georgia.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = MRN; 510(K)s with Product Code = MRN; 510(K)s with Product Code = MRN