Z-3306-2026

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

Name: Z-3306-2026 NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I
Creator: Noxbox Ltd
Published: 2026-09-14
License: https://open.fda.gov/license/

Noxbox Ltd / initiated 2026-09-14 / Open, Classified

FDA source

Recall record

Recall number: Z-3306-2026
Status: Open, Classified
Initiated: 2026-09-14
Posted: 2026-09-25
Recalling firm: Noxbox Ltd
Product: NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Product code: MRN Apparatus, Nitric Oxide Delivery
Reason for recall: Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
FDA 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 in commerce: 1,667 units
Distribution: US Nationwide distribution in the state of Georgia.
Product codes and lots: 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

Product code MRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)