{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-28", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222525", "product_res_number": "Z-3306-2026", "event_date_initiated": "2026-09-14", "event_date_posted": "2026-09-25", "recall_status": "Open, Classified", "res_event_number": "99816", "product_code": "MRN", "k_numbers": [ "K171696", "K201339", "K220898", "K231823", "K233251" ], "product_description": "NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.", "code_info": "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, 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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. \n\nIncludes NOxBOXi with Oxygen sensor lots manufactured before April 13, 2026", "firm_fei_number": "3012796317", "recalling_firm": "NOXBOX LTD", "address_1": "Unit 1 Eurolink Gateway Castle Road", "address_2": "Unit 1", "city": "Sittingbourne", "country": "United Kingdom", "reason_for_recall": "Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.", "root_cause_description": "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.\n\nDevice 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. \n\nNOxBOX 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. \n\nAs 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.", "product_quantity": "1,667 units", "distribution_pattern": "US Nationwide distribution in the state of Georgia.", "openfda": { "k_number": [ "K231823", "K093260", "K092545", "K211153", "K000653", "K080484", "K113272", "K110635", "K233251", "K061901", "K110344", "DEN000001", "K120216", "K242374", "K193481", "K000186", "K131686", "K200389", "K093922", "K071516", "K240410", "K212409", "K201339", "K242578", "K070867", "K033779", "K220898", "K081691", "K171696", "K222930", "K130605", "K143213", "K121021" ], "device_name": "Apparatus, Nitric Oxide Delivery", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5165", "device_class": "2", "registration_number": [ "2133810", "3012160128", "2518435", "3004531588", "3012796317", "3011193444", "1625392", "3019771924", "9611296", "3014527933", "3006897516" ], "fei_number": [ "1000058335", "3000203066", "3012160128", "3004531588", "3012796317", "3011193444", "2518435", "3019771924", "3014074925", "3002809568", "3006897516" ] } } ] }