CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report

NOxBOXi Nitric Oxide Delivery System recalled

Noxbox is recalling NOxBOXi Nitric Oxide Delivery System, distributed nationwide in the US. The recall was initiated on 14 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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

Quantity recalled1,667 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3306-2026
FDA event ID: 99816
Recalling firm: Noxbox, Sittingbourne
Classification: Class II
Status: Ongoing
Recall initiated: 14 Sep 2026
FDA classified: 25 Sep 2026
Reported: 7 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

14 Sep 2026	Recall initiated by company
25 Sep 2026	Classified by FDA	+11 days
7 Oct 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the state of Georgia.

Nationwide Georgia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the state of Georgia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Noxbox

All 6

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Packaging Defects	Nationwide
15 Oct 2025Device	CLASS I	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Other	TN
15 Oct 2025Device	CLASS I	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	TN
17 Sep 2025Device	CLASS II	NOxBOXi Nitric Oxide Delivery System recalled	Noxbox	Device Malfunction	Nationwide
21 Jun 2023Device	CLASS I	NOxBOXi Nitric Oxide Delivery System, Noxbox-i, Reqnoxbox-i recalled	Noxbox	Packaging Defects	Nationwide

Other Other Medical Devices recalls

All 13,884

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Palacos R pro recalled by Heraeus Medical GmbH (Dental	Heraeus Medical GmbH (Dental Division)	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Positron Emission Tomography and Computed Tomography System recalled	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire	Percussionaire	Other	Nationwide
7 Oct 2026Device	CLASS II	Atellica CH Revised C-Reactive Protein (RCRP) recalled	Siemens Healthcare Diagnostics	Other	Nationwide