NOxBOXi Nitric Oxide Delivery System — FDA record Z-2544-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
NOxBOXi Nitric Oxide Delivery System
Reason
Replacement of the internal Sample Pump due to high failure rates.
Classification
Class II
Recalling firm
NOXBOX LTD
Quantity
1,667 units
Agency-reported status
Ongoing
Source record identifier
Z-2544-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityModel No. NOXBOXI; UDI: 05060541640009; Serial No. NI102738, NI103021, NI103146, NI101560, NI101059, NI102922, NI101034, NI102152, NI102854, NI101289, NI102957, NI102642, NI101960, NI102163, NI101717, NI102928, NI101146, NI101209, NI102128, NI101751, NI101743, NI102266, NI101813, NI102037, NI102079, NI102850, NI100850, NI101221, NI101708, NI101744, NI101879, NI101905, NI101948, NI102410, NI101208, NI101354, NI101940, NI102117, NI102338, NI101002, NI101729, NI102094, NI102310, NI102676, NI102888, NI102683, NI102933, NI102537, NI101594, NI101958, NI101989, NI102104, NI102206, NI102620, NI102639, NI102696, NI102771, NI102814, NI102852, NI101147, NI102431, NI100983, NI101257, NI101353, NI101581, NI101987, NI102111, NI102308, NI102816, NI102908, NI102698, NI102725, NI102883, NI102932, NI102936, NI103084, NI101703, NI101993, NI102422, NI102485, NI102879, NI102939, NI101234, NI101821, NI102947, NI101029, NI101679, NI102031, NI102538, NI102624, NI102794, NI102839, NI102848, NI102865, NI102942, NI102999, NI101077, NI101600, NI102121, NI102424, NI102545, NI102812, NI102838, NI102849, NI102861, NI102877, NI102885, NI102944, NI101136, NI101340, NI101416, NI101916, NI101937, NI102060, NI102815, NI102437, NI102513, NI102541, NI102762, NI102828, NI102836, NI101380, NI101712, NI102062, NI102123, NI102278, NI102343, NI102492, NI102853, NI102963, NI102540, NI102727, NI102350, NI102382, NI102507, NI102604, NI102625, NI102658, NI102871, NI101095, NI102584, NI102726, NI102823, NI102832, NI102855, NI102998, NI103022, NI101081, NI101151, NI101211, NI101212, NI101726, NI102614, NI103012, NI101278, NI101638, NI101710, NI101775, NI102052, NI102168, NI102271, NI102274, NI102476, NI102659, NI102724, NI102825, NI101675, NI101769, NI101835, NI101901, NI101943, NI102076, NI102290, NI102475, NI102482, NI102562, NI102617, NI101869, NI102300, NI102670, NI102700, NI102913, NI101086, NI101288, NI101680, NI101716, NI101756, NI102053, NI102057, NI102068, NI102887, NI102929, NI102356, NI103011, NI103016, NI101148, NI101812, NI101952, NI102078, NI102110, NI100866, NI101149, NI101430, NI101446, NI101540, NI102219, NI102397, NI102488, NI102744, NI102864, NI103017, NI100895, NI101067, NI101207, NI101639, NI101684, NI101999, NI102240, NI103123, NI103126, NI103136, NI103151, NI103204, NI103208, NI101793, NI102588, NI103104, NI103127, NI103145, NI103203, NI100882, NI101163, NI101964, NI102166, NI103147, NI103148, NI103168, NI103181, NI103183, NI101084, NI101303, NI101782, NI101819, NI101857, NI101912, NI101970, NI102404, NI102561, NI102748, NI102759, NI102931, NI101100, NI101252, NI101467, NI101629, NI101654, NI101700, NI101732, NI101748, NI101794, NI101928, NI102072, NI102423, NI102463, NI102809, NI102973, NI103182, NI103220, NI100880, NI101156, NI101321, NI101896, NI101974, NI101995, NI102043, NI102049, NI102254, NI102286, NI102394, NI101044, NI101349, NI101357, NI101776, NI101814, NI101953, NI102021, NI102063, NI102114, NI102120, NI102435, NI102536, NI102722, NI102866, NI102164, NI102917, NI101028, NI101373, NI101449, NI101691, NI102023, NI102113, NI102141, NI102184, NI102345, NI102630, NI102645, NI102772, NI100953, NI101019, NI102445, NI102605, NI102962, NI101246, NI101356, NI101615, NI101778, NI102017, NI102148, NI102259, NI102616, NI100840, NI100869, NI102131, NI102402, NI102406, NI102415, NI103120, NI103139, NI100855, NI101026, NI101138, NI101223, NI101464, NI101554, NI101761, NI101796, NI101824, NI101906, NI102190, NI102967, NI101116, NI101205, NI101231, NI101379, NI101890, NI101939, NI102048, NI102484, NI100878, NI101013, NI101115, NI101444, NI101578, NI101608, NI101925, NI102241, NI102340, NI102564, NI102881, NI102911, NI100861, NI100976, NI101150, NI101161, NI101176, NI101402, NI101443, NI101478, NI101959, NI102284, NI102512, NI102598, NI102706, NI102834, NI101659, NI101765, NI102165, NI102180, NI102295, NI102506, NI102542, NI102576, NI102688, NI101006, NI101073, NI101153, NI101251, NI101390, NI101405, NI101815, NI101864, NI101867, NI102396, NI102766, NI102986, NI101031, NI101233, NI101244, NI101809, NI101891, NI101982, NI102008, NI102040, NI102081, NI102205, NI102288, NI102619, NI102656, NI101512, NI102096, NI102357, NI102486, NI102699, NI102784, NI103144, NI101107, NI101199, NI101265, NI101299, NI101685, NI101837, NI101996, NI102647, NI102651, NI102691, NI102818, NI102958, NI101219, NI101232, NI101245, NI101313, NI101344, NI101736, NI101979, NI102961, NI101227, NI101298, NI101843, NI101873, NI101926, NI102292, NI102494, NI101110, NI101327, NI101469, NI101572, NI101945, NI102196, NI102713, NI101065, NI101177, NI101317, NI101709, NI101841, NI101846, NI102230, NI102285, NI100887, NI101117, NI101135, NI101180, NI101237, NI101328, NI101651, NI102055, NI102233, NI102381, NI103155, NI101094, NI101612, NI101722, NI101746, NI102091, NI102097, NI102150, NI102395, NI102898, NI100876, NI101061, NI101165, NI101666, NI101682, NI101771, NI102145, NI102554, NI103116, NI103159, NI100999, NI101322, NI101347, NI101479, NI101724, NI102296, NI102842, NI103196, NI100872, NI101217, NI101350, NI102107, NI102138, NI102490, NI102502, NI102660, NI102681, NI102714, NI102843, NI103157, NI101057, NI101145, NI101216, NI101307, NI101384, NI101686, NI101787, NI102019, NI102071, NI102119, NI102172, NI102282, NI102411, NI102483, NI101160, NI101409, NI101460, NI102414, NI102553, NI102669, NI102785, NI101956, NI102362, NI102937, NI102383, NI102481, NI102594, NI103152, NI101101, NI101530, NI101941, NI102332, NI102610, NI101079, NI101431, NI101620, NI101983, NI102090, NI102118, NI102544, NI102557, NI102579, NI102757, NI100932, NI101083, NI101106, NI101159, NI101338, NI101388, NI101396, NI101486, NI101606, NI101665, NI102102, NI102192, NI102200, NI102802, NI102919, NI103083, NI101336, NI101439, NI101492, NI101565, NI102026, NI102247, NI102900, NI100881, NI101414, NI101942, NI102144, NI102452, NI101218, NI101250, NI102012, NI102427, NI102599, NI101155, NI101475, NI101954, NI101985, NI101175, NI101570, NI100975, NI101617, NI101660, NI101994, NI102279, NI101859, NI100993, NI101343, NI101411, NI101461, NI101697, NI102280, NI101309, NI101696, NI101862, NI102149, NI102235, NI102627, NI101090, NI101763, NI101961, NI102304, NI102363, NI102923, NI101263, NI101601, NI102046, NI102213, NI102408, NI101038, NI101521, NI101668, NI102330, NI102389, NI102731, NI101024, NI101694, NI101641, NI102186, NI101092, NI101109, NI101817, NI101910, NI101049, NI102065, NI102093, NI102417, NI101335, NI101392, NI101395, NI101842, NI102384, NI102528, NI100989, NI101133, NI101968, NI102640, NI103023, NI100980, NI101089, NI101505, NI102167, NI102253, NI100868, NI101017, NI101035, NI101142, NI102161, NI100839, NI101202, NI101566, NI101573, NI101884, NI102075, NI102245, NI102256, NI102432, NI101010, NI101282, NI101739, NI101838, NI102074, NI102525, NI101408, NI101489, NI101851, NI101903, NI102044, NI102198, NI100848, NI101113, NI101224, NI101285, NI102133, NI102560, NI100852, NI101014, NI101214, NI101462, NI102735, NI101766, NI101816, NI102275, NI102667, NI101266, NI101508, NI102027, NI102199, NI102216, NI101635, NI101885, NI102125, NI102238, NI103082, NI101105, NI101616, NI102126, NI102146, NI102739, NI100961, NI101907, NI102137, NI102607, NI102897, NI101553, NI101625, NI101662, NI101823, NI101990, NI101607, NI102193, NI102232, NI102298, NI102535, NI101329, NI101655, NI101797, NI101807, NI101946, NI101308, NI102268, NI102270, NI102276, NI102429, NI101337, NI101472, NI101557, NI102613, NI102717, NI101170, NI101377, NI102265, NI102306, NI102358, NI103001, NI101213, NI101429, NI101577, NI101876, NI102418, NI102608, NI101270, NI101844, NI101886, NI102001, NI102140, NI102305, NI102489, NI101645, NI101998, NI102059, NI102339, NI102359, NI102571, NI101134, NI101168, NI101287, NI101622, NI101657, NI102596, NI102920, NI100847, NI101064, NI101108, NI102520, NI102872, NI101254, NI102106, NI102169, NI102666, NI102702, NI101072, NI101342, NI102228, NI102403, NI102574, NI102175, NI100858, NI101636, NI102182, NI102227, NI102447, NI102472, NI000000, NI101015, NI102124, NI102215, NI102550, NI103014, NI101515, NI101977, NI102578, NI102745, NI103170, NI101039, NI101179, NI101992, NI102413, NI101004, NI101011, NI102992, NI101613, NI102025, NI102127, NI102134, NI101610, NI101914, NI101967, NI101976, NI102558, NI102032, NI102038, NI102160, NI102405, NI102692, NI101368, NI101991, NI102056, NI102195, NI101451, NI101783, NI102011, NI102631, NI102795, NI101576, NI102255, NI102970, NI102996, NI100942, NI101387, NI101404, NI102281, NI102747, NI100873, NI101264, NI101596, NI102552, NI101060, NI101585, NI102509, NI102597, NI103024, NI100935, NI101922, NI102018, NI102531, NI102547, NI101016, NI101588, NI101704, NI101711, NI101114, NI101268, NI101324, NI101592, NI101484, NI102311, NI102477, NI102655, NI102893, NI100841, NI101808, NI101840, NI102674, NI101271, NI101323, NI102020, NI100883, NI101220, NI102568, NI102689, NI101509, NI101836, NI102209, NI102497, NI102615, NI100885, NI101294, NI102392, NI102611, NI102649, NI101190, NI102287, NI101192, NI102355, NI102426, NI102566, NI102704, NI102728, NI101720, NI102177, NI102234, NI102511, NI102673, NI102858, NI101406, NI101677, NI101820, NI102737, NI101301, NI102510, NI102695, NI100996, NI101423, NI101584, NI102743, NI100851, NI101902, NI102061, NI102250, NI102643, NI101005, NI102183, NI102188, NI102399, NI101602, NI101849, NI102707, NI102746, NI101676, NI101692, NI102136, NI102587, NI102623, NI100859, NI101658, NI101798, NI101963, NI102729, NI101695, NI101957, NI102277, NI102438, NI101474, NI102585, NI102720, NI102742, NI102756, NI101130, NI101425, NI101522, NI101669, NI102546, NI100833, NI101524, NI101973, NI102092, NI101003, NI101767, NI101825, NI102730, NI101255, NI101437, NI101520, NI101611, NI102331, NI102593, NI102755, NI101412, NI101605, NI101747, NI101848, NI101981, NI102135, NI102249, NI102595, NI102708, NI102711, NI102752, NI102845, NI101491, NI102466, NI102703, NI101456, NI101731, NI101791, NI102299, NI102581, NI101810, NI102591, NI102808, NI101628, NI102083, NI102109, NI102790, NI101715, NI101822, NI102806, NI102977, NI101042, NI101740, NI102391, NI102496, NI102792, NI101375, NI102629, NI102904, NI101144, NI101178, NI101359, NI101532, NI102010, NI102291, NI102675, NI102697, NI101516, NI101690, NI101997, NI102273, NI102377, NI102480, NI100990, NI101719, NI101184, NI101693, NI101781, NI102307, NI102657, NI102662, NI102841, NI101243, NI101428, NI101448, NI102283, NI102425, NI102543, NI103153, NI101640, NI101305, NI101386, NI102297, NI102914, NI101230, NI101473, NI101627, NI102070, NI102191, NI102327, NI102341, NI102380, NI102997, NI101033, NI101483, NI101173, NI101924, NI102602, NI102478, NI101292, NI101598, NI101832, NI100875, NI100987, NI101434, NI101799, NI102387, NI102890, NI101312, NI101468, NI101805, NI101881, NI102570, NI102671, NI100849, NI100888, NI101131, NI101381, NI101920, NI102237, NI102398, NI102668, NI102768, NI101030, NI101099, NI101496, NI101898, NI102246, NI102349, NI102634, NI102801, NI103074, NI103087, NI100994, NI101593, NI101604, NI101644, NI101718, NI102559, NI102565, NI102582, NI102600, NI102618, NI102685, NI102732, NI102905, NI100986, NI101643, NI102170, NI102504, NI102680, NI102817, NI102846, NI103002, NI101351, NI101360, NI102194, NI102781, NI101868, NI101878, NI102069, NI102777, NI101001, NI101071, NI101253, NI101295, NI101314, NI101595, NI102174, NI102433, NI102473, NI102661, NI102799, NI102934, NI101415, NI101426, NI101481, NI102009, NI102047, NI102272, NI102364, NI102444, NI102499, NI102556, NI102590, NI102709, NI102736, NI102830, NI102862, NI103215, NI101330, NI101865, NI101892, NI102115, NI102856, NI102918, NI101236, NI101826, NI102498, NI101158, NI101361, NI101574, NI101919, NI102028, NI102586, NI102622, NI101225, NI101672, NI101750, NI101874, NI102927, NI102244, NI101563, NI101678, NI101880, NI102366, NI102648, NI102892, NI101355, NI101457, NI101614, NI101689, NI101777, NI101671, NI101965, NI102269, NI103189, NI101376, NI101514, NI101759, NI101955, NI101687, NI102024, NI102155, NI102741, NI102878, NI101591, NI1022...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution in the state of TN.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Sep 17, 2025
Recall initiation date
Jul 19, 2023
Center classification date
Sep 9, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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