NOXBOX LTD: NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.

Recall number

Z-3306-2026

Recalling firm

NOXBOX LTD

Product

NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.

Status

Open, Classified

Initiated

2026-09-14

Posted

2026-09-25

Terminated

not on file

Reason

Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.

Root cause

Component design/selection

Action

On 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

1,667 units

Distribution

US Nationwide distribution in the state of Georgia.

Lot, serial or model codes

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

510(k) numbers

["K171696","K201339","K220898","K231823","K233251"]

PMA numbers

not on file

Product code

MRN

Firm FEI

3012796317

Firm city

Sittingbourne

Firm state

not on file

Firm country

United Kingdom

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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