Class 2 Device Recall NOxBOXi Nitric Oxide Delivery System

• Date Initiated by Firm: July 19, 2023
• Date Posted: September 09, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2544-2025
• Recall Event ID: 97417
• 510(K)Number: K171696
• Product Classification: Apparatus, nitric oxide delivery - Product Code MRN
• Product: NOxBOXi Nitric Oxide Delivery System
• Code Information: Model 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, NI102222, NI102884, NI102987, NI101413, NI101895, NI102103, NI102804, NI101784, NI102173, NI102361, NI102569, NI102770, NI102910, NI101441, NI101459, NI102116, NI102189, NI102385, NI102479, NI101656, NI101889, NI101913, NI102518, NI103122, NI101527, NI101988, NI102176, NI102212, NI102347, NI102798, NI102979, NI102035, NI102733, NI102876, NI101526, NI101706, NI101883, NI102142, NI102214, NI102293, NI102555, NI102567, NI102635, NI102638, NI102760, NI102968, NI101590, NI102147, NI102329, NI102551, NI102767, NI102789, NI102891, NI101487, NI101525, NI101667, NI101699, NI101723, NI101737, NI102517, NI102819, NI102882, NI101432, NI101463, NI101533, NI101623, NI102036, NI102519, NI102950, NI101742, NI102171, NI102436, NI102563, NI101713, NI101749, NI102045, NI103094, NI102474, NI102575, NI102763, NI101442, NI101550, NI101861, NI102467, NI102522, NI102539, NI102837, NI102860, NI101433, NI101597, NI101768, NI102221, NI102693, NI101972, NI102208, NI102487, NI102637, NI102653, NI102705, NI103018, NI103020, NI103079, NI102015, NI102393, NI102400, NI102601, NI102764, NI102847, NI102899, NI102907, NI101986, NI102098, NI102734, NI102803, NI102955, NI102684, NI102710, NI102915, NI103019, NI102077, NI102095, NI102530, NI102580, NI102906, NI103003, NI101167, NI101872, NI102990, NI102434, NI102686, NI102894, NI101454, NI101683, NI101811, NI102000, NI102197, NI102889, NI101579, NI102753, NI102793, NI102880, NI101714, NI101394, NI101984, NI102013, NI102428, NI102776, NI101410, NI101609, NI101753, NI101845, NI102628, NI102758, NI101599, NI101664, NI101674, NI101975, NI102239, NI102351, NI102501, NI102503, NI102577, NI102664, NI102740, NI102870, NI102935, NI102309, NI102840, NI102926, NI101626, NI101688, NI101760, NI101854, NI101887, NI102099, NI102495, NI102652, NI102783, NI102805, NI102810, NI102003, NI102139, NI102226, NI102715, NI102791, NI102821, NI102966, NI103089, NI101670, NI101882, NI101904, NI102930, NI103085, NI102991, NI101575, NI101829, NI101393, NI102342, NI102346, NI102663, NI102873, NI101407, NI101707, NI101735, NI101770, NI101962, NI102051, NI102807, NI102868, NI102901, NI101506, NI101529, NI102811, NI102863, NI102916, NI103091, NI101435, NI101899, NI102004, NI102067, NI102592, NI102687, NI102751, NI103093, NI103095, NI102989, NI102824, NI102641, NI102548, NI102774, NI102800, NI101944, NI102672, NI102859, NI101551, NI101733, NI102089, NI102390, NI102621, NI102632, NI102701, NI102833, NI102874, NI102921, NI101624, NI102773, NI101971, NI102902, NI103117, NI100862, NI100978, NI101228, NI101241, NI101256, NI101258, NI101284, NI101297, NI101300, NI101311, NI101721, NI101831, NI101229, NI101828, NI103007, NI101041, NI101204, NI101273, NI101286, NI101490, NI100884, NI101215, NI101222, NI101795, NI101012, NI101018, NI101080, NI101088, NI101091, NI101093, NI100948, NI100991, NI100997, NI101069, NI101125, NI102813, NI102851, NI100879, NI101154, NI101181, NI101182, NI101183, NI101063, NI101482, NI101112, NI101804, NI102006, NI102500, NI101132, NI101164, NI101174, NI101009, NI101372, NI102108, NI102844, NI102007, NI101569, NI101978, NI102105, NI101806, NI102086, NI102263, NI101485, NI101818, NI101333, NI101681, NI102360, NI102769, NI101908, NI101346, NI101909, NI102082, NI103088, NI102002, NI101552, NI102778, NI102765, NI102964, NI102014, NI102129, NI100865, NI101008, NI101966, NI101048, NI101259, NI102606, NI101936, NI102886, NI103264, NI103298, NI103322, NI103287, NI103317, NI100949, NI101947, NI100886, NI101137, NI101162, NI103302, NI103305, NI103307, NI103311, NI103321, NI101728, NI101436, NI101452, NI100951, NI100982, NI100988, NI100992, NI101000, NI101025, NI101056, NI101074, NI101075, NI101076, NI101085, NI101087, NI101098, NI101119, NI101120, NI101129, NI101139, NI101143, NI101152, NI101166, NI101201, NI101203, NI101206, NI101210, NI101226, NI101248, NI101272, NI101283, NI101290, NI101293, NI101302, NI101348, NI101403, NI101417, NI101427, NI101447, NI101465, NI101501, NI101502, NI101507, NI101555, NI101562, NI101580, NI101589, NI101603, NI101618, NI101619, NI101630, NI101631, NI101632, NI101661, NI101663, NI101698, NI101725, NI101734, NI101785, NI101847, NI101863, NI101870, NI101877, NI101921, NI101927, NI101929, NI101950, NI101969, NI102022, NI102030, NI102039, NI102054, NI102058, NI102064, NI102066, NI102073, NI102080, NI102084, NI102112, NI102143, NI102151, NI102187, NI102229, NI102243, NI102294, NI102312, NI102348, NI102388, NI102401, NI102491, NI102493, NI102514, NI102515, NI102573, NI102589, NI102626, NI102633, NI102636, NI102646, NI102650, NI102654, NI102679, NI102682, NI102690, NI102712, NI102750, NI102775, NI102779, NI102780, NI102796, NI102829, NI102835, NI102867, NI102896, NI102909, NI102912, NI102925, NI103064, NI103076, NI103092, NI103132.
• Recalling Firm/ Manufacturer: NOXBOX LTD; Unit 1; Eurolink Gateway; Castle Road; Sittingbourne United Kingdom
• For Additional Information Contact: Heather Thomas; 302-513-0898
• Manufacturer Reason for Recall: Replacement of the internal Sample Pump due to high failure rates.
• FDA Determined Cause: Component design/selection
• Action: An email with the subject "New Internal Sampling Pump" was sent to consignees on 7/19/2023 notifying them that the internal Sampling Pump of NOxBOXi Nitric Oxide Delivery System devices was to be replaced. The replacement does not change the use of the device but does result in a quieter device functionality. This replacement will be conducted during annual servicing by Level 3 Service Engineers at authorized NOXBOX Service Centers. Consignees with any questions are to email NOxBOX_aqtech@linde.com or their account manager.
• Quantity in Commerce: 1,667 units
• Distribution: US Nationwide distribution in the state of TN.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = MRN