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U.S. Department of Health and Human Services

Class 2 Device Recall NOxBOXi Nitric Oxide Delivery System

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 Class 2 Device Recall NOxBOXi Nitric Oxide Delivery Systemsee related information
Date Initiated by FirmSeptember 14, 2026
Date PostedSeptember 25, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3306-2026
Recall Event ID 99816
510(K)NumberK171696 K201339 K220898 K231823 K233251 
Product Classification Apparatus, nitric oxide delivery - Product Code MRN
ProductNOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Code Information Model Number: NOXBOX-I. UDI-DI: 05060541640009. Serial Numbers: NI100825, NI100833, NI100839, NI100840, NI100841, NI100847, NI100848, NI100849, NI100850, NI100851, NI100852, NI100855, NI100858, NI100859, NI100861, NI100862, NI100865, NI100866, NI100868, NI100869, NI100872, NI100873, NI100875, NI100876, NI100878, NI100879, NI100880, NI100881, NI100882, NI100883, NI100884, NI100885, NI100886, NI100887, NI100888, NI100895, NI100932, NI100935, NI100942, NI100948, NI100949, NI100953, NI100961, NI100975, NI100976, NI100978, Serial Number, NI100980, NI100983, NI100985, NI100986, NI100987, NI100989, NI100990, NI100991, NI100993, NI100994, NI100996, NI100997, NI100999, NI101001, NI101002, NI101003, NI101004, NI101005, NI101006, NI101008, NI101009, NI101010, NI101011, NI101012, NI101013, NI101014, NI101015, NI101017, NI101018, NI101019, NI101024, NI101026, NI101028, NI101029, NI101030, NI101031, NI101033, NI101034, NI101035, NI101038, NI101039, NI101041, NI101042, NI101044, NI101048, NI101049, Serial Number, NI101052, NI101057, NI101059, NI101060, NI101061, NI101063, NI101065, NI101067, NI101069, NI101071, NI101072, NI101073, NI101077, NI101079, NI101080, NI101081, NI101083, NI101084, NI101086, NI101088, NI101089, NI101090, NI101091, NI101092, NI101093, NI101094, NI101095, NI101099, NI101100, NI101101, NI101105, NI101106, NI101107, NI101108, NI101109, NI101110, NI101111, NI101112, NI101113, NI101114, NI101115, NI101116, NI101117, NI101125, NI101130, NI101131, Serial Number, NI101132, NI101133, NI101134, NI101135, NI101136, NI101137, NI101138, NI101141, NI101142, NI101144, NI101145, NI101146, NI101147, NI101148, NI101149, NI101150, NI101151, NI101153, NI101154, NI101155, NI101156, NI101158, NI101159, NI101160, NI101161, NI101162, NI101163, NI101164, NI101165, NI101167, NI101168, NI101170, NI101173, NI101174, NI101175, NI101176, NI101177, NI101178, NI101179, NI101180, NI101181, NI101182, NI101183, NI101184, NI101190, NI101191, Serial Number, NI101192, NI101199, NI101202, NI101204, NI101205, NI101207, NI101208, NI101209, NI101211, NI101212, NI101213, NI101214, NI101215, NI101216, NI101217, NI101218, NI101219, NI101220, NI101221, NI101222, NI101223, NI101224, NI101225, NI101227, NI101228, NI101229, NI101230, NI101231, NI101232, NI101233, NI101234, NI101236, NI101237, NI101241, NI101243, NI101244, NI101245, NI101246, NI101249, NI101250, NI101251, NI101252, NI101253, NI101254, NI101255, NI101256, Serial Number, NI101257, NI101258, NI101259, NI101263, NI101264, NI101265, NI101266, NI101268, NI101270, NI101271, NI101273, NI101278, NI101282, NI101284, NI101285, NI101286, NI101287, NI101288, NI101289, NI101292, NI101294, NI101295, NI101297, NI101298, NI101299, NI101300, NI101301, NI101303, NI101305, NI101307, NI101308, NI101309, NI101313, NI101314, NI101317, NI101321, NI101322, NI101323, NI101324, NI101326, NI101327, NI101328, NI101329, NI101330, NI101331, NI101333, Serial Number, NI101335, NI101336, NI101337, NI101338, NI101340, NI101342, NI101344, NI101346, NI101347, NI101349, NI101350, NI101351, NI101353, NI101354, NI101355, NI101356, NI101357, NI101359, NI101360, NI101361, NI101368, NI101372, NI101373, NI101376, NI101377, NI101379, NI101380, NI101381, NI101384, NI101386, NI101387, NI101388, NI101390, NI101392, NI101393, NI101394, NI101395, NI101396, NI101402, NI101404, NI101405, NI101406, NI101407, NI101408, NI101409, NI101410, Serial Number, NI101411, NI101412, NI101413, NI101414, NI101415, NI101416, NI101423, NI101425, NI101426, NI101428, NI101429, NI101430, NI101431, NI101432, NI101433, NI101434, NI101435, NI101436, NI101437, NI101439, NI101441, NI101442, NI101443, NI101444, NI101446, NI101448, NI101449, NI101451, NI101452, NI101454, NI101456, NI101457, NI101459, NI101460, NI101461, NI101462, NI101463, NI101464, NI101467, NI101468, NI101469, NI101472, NI101473, NI101474, NI101475, NI101478, Serial Number, NI101479, NI101482, NI101483, NI101484, NI101485, NI101486, NI101487, NI101489, NI101490, NI101491, NI101492, NI101496, NI101505, NI101506, NI101508, NI101509, NI101512, NI101514, NI101515, NI101516, NI101520, NI101521, NI101522, NI101524, NI101525, NI101526, NI101527, NI101529, NI101530, NI101532, NI101533, NI101540, NI101550, NI101551, NI101552, NI101553, NI101554, NI101557, NI101560, NI101563, NI101565, NI101566, NI101569, NI101570, NI101572, NI101573, Serial Number, NI101574, NI101575, NI101576, NI101577, NI101578, NI101579, NI101581, NI101584, NI101585, NI101588, NI101590, NI101591, NI101592, NI101593, NI101594, NI101595, NI101596, NI101597, NI101598, NI101599, NI101600, NI101601, NI101602, NI101604, NI101605, NI101606, NI101607, NI101608, NI101609, NI101610, NI101611, NI101612, NI101613, NI101614, NI101615, NI101616, NI101617, NI101620, NI101622, NI101623, NI101624, NI101625, NI101626, NI101627, NI101628, NI101629, Serial Number, NI101635, NI101636, NI101638, NI101639, NI101640, NI101641, NI101643, NI101644, NI101645, NI101651, NI101654, NI101655, NI101656, NI101657, NI101658, NI101659, NI101660, NI101662, NI101664, NI101665, NI101666, NI101667, NI101668, NI101669, NI101670, NI101671, NI101672, NI101674, NI101675, NI101676, NI101677, NI101678, NI101679, NI101680, NI101681, NI101682, NI101683, NI101684, NI101685, NI101686, NI101687, NI101688, NI101689, NI101690, NI101691, NI101692, Serial Number, NI101693, NI101694, NI101695, NI101696, NI101697, NI101699, NI101700, NI101703, NI101704, NI101705, NI101706, NI101707, NI101708, NI101709, NI101710, NI101711, NI101712, NI101713, NI101714, NI101715, NI101716, NI101717, NI101718, NI101719, NI101720, NI101721, NI101722, NI101723, NI101724, NI101726, NI101727, NI101729, NI101731, NI101732, NI101733, NI101735, NI101736, NI101737, NI101739, NI101740, NI101742, NI101743, NI101744, NI101746, NI101747, NI101748, Serial Number, NI101749, NI101750, NI101751, NI101753, NI101756, NI101759, NI101760, NI101761, NI101763, NI101765, NI101766, NI101767, NI101768, NI101769, NI101770, NI101771, NI101775, NI101776, NI101777, NI101778, NI101781, NI101782, NI101783, NI101784, NI101787, NI101791, NI101793, NI101794, NI101795, NI101796, NI101797, NI101798, NI101799, NI101804, NI101805, NI101806, NI101807, NI101808, NI101809, NI101810, NI101811, NI101812, NI101813, NI101814, NI101815, NI101816, Serial Number, NI101817, NI101818, NI101819, NI101820, NI101821, NI101822, NI101823, NI101824, NI101825, NI101826, NI101828, NI101829, NI101831, NI101832, NI101834, NI101835, NI101836, NI101837, NI101838, NI101840, NI101841, NI101842, NI101843, NI101844, NI101845, NI101846, NI101848, NI101849, NI101851, NI101854, NI101857, NI101859, NI101861, NI101862, NI101864, NI101865, NI101867, NI101868, NI101869, NI101872, NI101873, NI101874, NI101875, NI101876, NI101878, NI101879, Serial Number, NI101880, NI101881, NI101882, NI101883, NI101884, NI101885, NI101886, NI101887, NI101889, NI101890, NI101891, NI101892, NI101895, NI101896, NI101898, NI101899, NI101901, NI101902, NI101903, NI101904, NI101905, NI101906, NI101907, NI101908, NI101909, NI101910, NI101912, NI101913, NI101914, NI101916, NI101919, NI101920, NI101922, NI101924, NI101925, NI101926, NI101928, NI101936, NI101937, NI101939, NI101940, NI101941, NI101942, NI101943, NI101944, NI101945, Serial Number, NI101946, NI101947, NI101948, NI101952, NI101953, NI101954, NI101955, NI101956, NI101957, NI101958, NI101959, NI101960, NI101961, NI101962, NI101963, NI101964, NI101965, NI101966, NI101967, NI101968, NI101970, NI101971, NI101972, NI101973, NI101974, NI101975, NI101976, NI101977, NI101978, NI101979, NI101981, NI101982, NI101983, NI101984, NI101985, NI101986, NI101987, NI101988, NI101989, NI101990, NI101991, NI101992, NI101993, NI101994, NI101995, NI101996, Serial Number, NI101997, NI101998, NI101999, NI102000, NI102001, NI102002, NI102003, NI102004, NI102006, NI102007, NI102008, NI102009, NI102010, NI102011, NI102012, NI102013, NI102014, NI102015, NI102017, NI102018, NI102019, NI102020, NI102021, NI102023, NI102024, NI102025, NI102026, NI102027, NI102028, NI102031, NI102032, NI102033, NI102035, NI102036, NI102037, NI102038, NI102040, NI102043, NI102044, NI102045, NI102046, NI102047, NI102048, NI102049, NI102051, NI102052, Serial Number, NI102053, NI102055, NI102056, NI102057, NI102059, NI102060, NI102061, NI102062, NI102063, NI102065, NI102067, NI102068, NI102069, NI102070, NI102071, NI102072, NI102074, NI102075, NI102076, NI102077, NI102078, NI102079, NI102081, NI102082, NI102083, NI102086, NI102089, NI102090, NI102091, NI102092, NI102093, NI102094, NI102095, NI102096, NI102097, NI102098, NI102099, NI102102, NI102103, NI102104, NI102105, NI102106, NI102107, NI102108, NI102109, NI102110, Serial Number, NI102111, NI102113, NI102114, NI102115, NI102116, NI102117, NI102118, NI102119, NI102120, NI102121, NI102123, NI102124, NI102125, NI102126, NI102127, NI102128, NI102129, NI102131, NI102132, NI102133, NI102134, NI102135, NI102136, NI102137, NI102138, NI102139, NI102140, NI102141, NI102142, NI102144, NI102145, NI102146, NI102147, NI102148, NI102149, NI102150, NI102152, NI102155, NI102160, NI102161, NI102163, NI102164, NI102165, NI102166, NI102167, NI102168, Serial Number, NI102169, NI102170, NI102171, NI102172, NI102173, NI102174, NI102175, NI102176, NI102177, NI102180, NI102182, NI102183, NI102184, NI102186, NI102188, NI102189, NI102190, NI102191, NI102192, NI102193, NI102194, NI102195, NI102196, NI102197, NI102198, NI102199, NI102200, NI102205, NI102206, NI102208, NI102209, NI102212, NI102213, NI102214, NI102215, NI102216, NI102219, NI102221, NI102222, NI102226, NI102227, NI102228, NI102230, NI102231, NI102232, NI102233, Serial Number, NI102234, NI102235, NI102237, NI102238, NI102239, NI102240, NI102241, NI102244, NI102245, NI102246, NI102247, NI102249, NI102250, NI102253, NI102254, NI102255, NI102256, NI102259, NI102263, NI102265, NI102266, NI102268, NI102269, NI102270, NI102271, NI102272, NI102273, NI102274, NI102275, NI102276, NI102277, NI102278, NI102279, NI102280, NI102281, NI102282, NI102283, NI102284, NI102285, NI102286, NI102287, NI102288, NI102290, NI102291, NI102292, NI102293, Serial Number, NI102295, NI102296, NI102297, NI102298, NI102299, NI102300, NI102304, NI102305, NI102306, NI102307, NI102308, NI102309, NI102310, NI102311, NI102327, NI102329, NI102330, NI102331, NI102332, NI102338, NI102339, NI102340, NI102341, NI102342, NI102343, NI102345, NI102346, NI102347, NI102349, NI102350, NI102351, NI102355, NI102356, NI102357, NI102358, NI102359, NI102360, NI102361, NI102362, NI102363, NI102364, NI102366, NI102377, NI102380, NI102381, NI102383, Serial Number, NI102384, NI102385, NI102387, NI102389, NI102390, NI102391, NI102392, NI102393, NI102394, NI102395, NI102396, NI102397, NI102398, NI102399, NI102400, NI102402, NI102403, NI102404, NI102405, NI102406, NI102407, NI102408, NI102410, NI102411, NI102413, NI102414, NI102415, NI102417, NI102418, NI102422, NI102423, NI102424, NI102425, NI102426, NI102427, NI102428, NI102429, NI102431, NI102432, NI102433, NI102434, NI102435, NI102436, NI102437, NI102438, NI102444, Serial Number, NI102445, NI102447, NI102463, NI102466, NI102467, NI102472, NI102473, NI102474, NI102475, NI102476, NI102477, NI102478, NI102479, NI102480, NI102481, NI102482, NI102483, NI102484, NI102485, NI102486, NI102487, NI102488, NI102489, NI102490, NI102492, NI102494, NI102495, NI102496, NI102497, NI102498, NI102499, NI102500, NI102501, NI102502, NI102503, NI102504, NI102506, NI102507, NI102509, NI102510, NI102511, NI102512, NI102513, NI102517, NI102518, NI102519, Serial Number, NI102520, NI102522, NI102525, NI102528, NI102530, NI102531, NI102535, NI102536, NI102537, NI102538, NI102539, NI102540, NI102541, NI102542, NI102543, NI102544, NI102545, NI102546, NI102547, NI102548, NI102550, NI102551, NI102552, NI102553, NI102554, NI102555, NI102556, NI102557, NI102558, NI102560, NI102561, NI102562, NI102563, NI102564, NI102565, NI102566, NI102567, NI102568, NI102569, NI102570, NI102571, NI102574, NI102575, NI102576, NI102577, NI102578, Serial Number, NI102579, NI102580, NI102581, NI102582, NI102583, NI102584, NI102585, NI102586, NI102587, NI102588, NI102590, NI102591, NI102592, NI102593, NI102594, NI102595, NI102596, NI102597, NI102598, NI102599, NI102600, NI102601, NI102602, NI102604, NI102605, NI102606, NI102607, NI102608, NI102610, NI102611, NI102613, NI102614, NI102615, NI102616, NI102617, NI102618, NI102619, NI102620, NI102621, NI102622, NI102623, NI102624, NI102625, NI102627, NI102628, NI102629, Serial Number, NI102630, NI102631, NI102632, NI102634, NI102635, NI102637, NI102638, NI102639, NI102640, NI102641, NI102642, NI102643, NI102645, NI102647, NI102648, NI102649, NI102651, NI102652, NI102653, NI102655, NI102656, NI102657, NI102658, NI102659, NI102660, NI102661, NI102662, NI102663, NI102664, NI102665, NI102666, NI102667, NI102668, NI102669, NI102670, NI102671, NI102672, NI102673, NI102674, NI102675, NI102676, NI102680, NI102681, NI102683, NI102684, NI102685, Serial Number, NI102686, NI102687, NI102688, NI102689, NI102691, NI102692, NI102693, NI102695, NI102696, NI102697, NI102698, NI102699, NI102700, NI102701, NI102702, NI102703, NI102704, NI102705, NI102706, NI102707, NI102708, NI102709, NI102710, NI102711, NI102713, NI102714, NI102715, NI102717, NI102720, NI102722, NI102724, NI102725, NI102726, NI102727, NI102728, NI102729, NI102730, NI102731, NI102732, NI102733, NI102734, NI102735, NI102736, NI102737, NI102738, NI102739, Serial Number, NI102740, NI102741, NI102742, NI102743, NI102744, NI102745, NI102746, NI102747, NI102748, NI102751, NI102752, NI102753, NI102755, NI102756, NI102757, NI102758, NI102759, NI102760, NI102762, NI102763, NI102764, NI102765, NI102766, NI102767, NI102768, NI102769, NI102770, NI102771, NI102772, NI102773, NI102774, NI102776, NI102777, NI102778, NI102781, NI102783, NI102784, NI102785, NI102786, NI102789, NI102790, NI102791, NI102792, NI102793, NI102794, NI102795, Serial Number, NI102798, NI102799, NI102800, NI102801, NI102802, NI102803, NI102804, NI102805, NI102806, NI102807, NI102808, NI102809, NI102810, NI102811, NI102812, NI102813, NI102814, NI102815, NI102816, NI102817, NI102818, NI102819, NI102821, NI102823, NI102824, NI102825, NI102828, NI102830, NI102832, NI102833, NI102834, NI102836, NI102837, NI102838, NI102839, NI102840, NI102841, NI102842, NI102843, NI102844, NI102845, NI102846, NI102847, NI102848, NI102849, NI102850, Serial Number, NI102851, NI102852, NI102853, NI102854, NI102855, NI102856, NI102858, NI102859, NI102860, NI102861, NI102862, NI102863, NI102865, NI102866, NI102868, NI102870, NI102871, NI102872, NI102873, NI102874, NI102876, NI102877, NI102878, NI102879, NI102880, NI102881, NI102882, NI102883, NI102884, NI102885, NI102886, NI102887, NI102888, NI102889, NI102890, NI102891, NI102892, NI102893, NI102894, NI102897, NI102898, NI102899, NI102900, NI102901, NI102902, NI102904, Serial Number, NI102905, NI102906, NI102907, NI102908, NI102910, NI102911, NI102913, NI102914, NI102915, NI102916, NI102917, NI102918, NI102919, NI102920, NI102921, NI102922, NI102923, NI102926, NI102927, NI102928, NI102929, NI102930, NI102931, NI102932, NI102933, NI102934, NI102935, NI102936, NI102937, NI102939, NI102942, NI102944, NI102947, NI102950, NI102955, NI102957, NI102958, NI102961, NI102962, NI102963, NI102964, NI102966, NI102967, NI102968, NI102970, NI102973, Serial Number, NI102977, NI102979, NI102986, NI102987, NI102989, NI102990, NI102991, NI102992, NI102996, NI102997, NI102998, NI102999, NI103001, NI103002, NI103003, NI103007, NI103011, NI103012, NI103014, NI103016, NI103017, NI103018, NI103019, NI103020, NI103021, NI103022, NI103023, NI103024, NI103074, NI103079, NI103082, NI103083, NI103084, NI103085, NI103087, NI103088, NI103089, NI103091, NI103093, NI103094, NI103095, NI103104, NI103116, NI103117, NI103120, NI103122, Serial Number, NI103123, NI103126, NI103127, NI103131, NI103136, NI103139, NI103144, NI103145, NI103146, NI103147, NI103148, NI103151, NI103152, NI103153, NI103155, NI103157, NI103159, NI103168, NI103170, NI103181, NI103182, NI103183, NI103189, NI103196, NI103203, NI103204, NI103208, NI103215, NI103220. Includes NOxBOXi with Oxygen sensor lots manufactured before April 13, 2026
FEI Number 3012796317
Recalling Firm/
Manufacturer		 NOXBOX LTD
Unit 1
Eurolink Gateway; Castle Road
Sittingbourne United Kingdom
Manufacturer Reason
for Recall		Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
FDA Determined
Cause 2		Component design/selection
ActionOn about 08/31/2026 NOXBOX initially notified its single distributor of the recall via emailed URGENT MEDCIAL DEVICE CORRECTION letter. The letter instructed distributors to examine inventory for affected units, complete and return the provided Distributor Response Form, arrange for the replacement of affected oxygen sensors, perform all preventive maintenance checks on NOxBOXi devices prior to distribution of units, ensure all applicable personnel are notified within the organization, notify all customers who have received affected units. Device users were instructed to examine inventory for affected units, complete and return the provided Customer Response Form to their respective distributor, ensure all applicable personnel or organizations (if units were transferred) are notified within the organization, and ensure personnel using the device are made aware. NOxBOX is working with the oxygen sensor manufacturer to obtain replacement sensors for all affected devices and will coordinate with distributors to implement sensor replacement activities. As such, NOxBOX is asking distributors and customers to promptly return the Response Forms as instructed on the form to confirm the number devices still in service and the number of sensor replacements required.
Quantity in Commerce1,667 units
DistributionUS Nationwide distribution in the state of Georgia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MRN
510(K)s with Product Code = MRN
510(K)s with Product Code = MRN
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