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RecallWatchMedical Device Safety
Class IIOngoingZ-2544-2025

NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System

NOXBOX LTDSittingbourne, United KingdomReported Sep 17, 2025 · 11 months ago
Legal News Analyst ·

Reason for recall

Replacement of the internal Sample Pump due to high failure rates.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

NOxBOXi Nitric Oxide Delivery System

Lot / code information

Model
XBOXI
UDI
05060541640009
Serial #
NI102738, NI103021, NI103146, NI101560, NI101059, NI102922 — +1661 moreShow all
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, …

What the firm is doing

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.

DistributionShow details

US Nationwide distribution in the state of TN.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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