Covidien recalls Newport HT70 Ventilator
Reason for recall
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
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.
Newport HT70 Ventilator23 codes
- HT70M-JP-NA
- HT70M-CN-NA
- HT70M-ES-EU
- HT70M-PT-BR
- HT70M-SY-EU
- HT70M-WW-EU
- HT70M-WW-NA
- HT70-SY-EU. Newport HT70Plus Ventilator
- HT70PM-ES-EU
- HT70PM-ES-NA
- HT70PM-JP-NA
- HT70PM-PT-BR
- HT70PM-SY-AS
- DLHT70PM-WW-NA
- HT70PM-SY-NA
- HT70PM-SY-UK
- HT70PM-WW-EU
- HT70PM-WW-UK
- HT70PM-SY-EU
- HT70PM-WWNA. HT70-2 CONTROL BOARD ROHS X1
- GR105796. HT70P CONTROL BOARD ROHS X1
- GR105795. HT70 Conversion Kit
- GRFSKHT70M-2.
Lot / code information
- Serial #
HT70M-JP-NA/00839935008221/N10HT700710132, N10HT700710135, N10HT700710136, N10HT700710159, N10HT700710161, N10HT700710162 — +2106 moreShow all
HT70M-JP-NA/00839935008221/N10HT700710132, N10HT700710135, N10HT700710136, N10HT700710159, N10HT700710161, N10HT700710162, N10HT700710163, N10HT700710164, N10HT700810194, N10HT700810199, N10HT700810202, N10HT700810204, N10HT700810205, N10HT700810206, N10HT700910223, N10HT700910227, N10HT701010279, N10HT701011015, N10HT701011016, N10HT701111044, N10HT701111048, N10HT701111049, N10HT701111050, N11HT700111137, N11HT700111139, N11HT700111141, N11HT700111142, N11HT700111143, N11HT700111144, N11HT700211145, N11HT700211155, N11HT700211160, N11HT700211161, N11HT700211163, N11HT700211164, N11HT700311168, N11HT700311169, N11HT700311170, N11HT700311183, N11HT700311184, N11HT700311185, N11HT700311186, N11HT700311188, N11HT700311189, N11HT700311191, N11HT700311192, N11HT700311193, N11HT700311195, N11HT700311196, N11HT700311197, N11HT700311201, N11HT700311202, N11HT700311203, N11HT700311204, N11HT700311207, N11HT700311208, N11HT700311209, N11HT700311233, N11HT700311234, N11HT700311243, N11HT700311244, N11HT700311245, N11HT700311246, N11HT700311247, N11HT700311248, N11HT700311250, N11HT700311251, N11HT700311253, N11HT700311255, N11HT700411256, N11HT700411257, N11HT700411258, N11HT700411262, N11HT700411263, N11HT700411264, N11HT700411265, N11HT700411266, N11HT700411267, N11HT700411268, N11HT700411271, N11HT700411277, N11HT700411278, N11HT700411279, N11HT700411282, N11HT700411284, N11HT700411285, N11HT700411286, N11HT700411287, N11HT700411288, N11HT700411289, N11HT700411290, N11HT700411291, N11HT700411292, N11HT700411307, N11HT700411308, N11HT700411310, N11HT700411311, N11HT700411313, N11HT700411314, N11HT700411315, N11HT700411317, N11HT700411319, N11HT700411327, N11HT700411329, N11HT700511439, N11HT700511440, N11HT700511441, N11HT700511442, N11HT700511443, N11HT700511444, N11HT700511445, N11HT700511446, N11HT700511453, N11HT700511454, N11HT700511456, N11HT700511457, N11HT700511458, N11HT700511466, N11HT700511467, N11HT700511468, N11HT700511472, N11HT700511473, N11HT700511507, N11HT700511508, N11HT700511509, N11HT700511510, N11HT700511511, N11HT700511512, N11HT700511513, N11HT700511514, N11HT700511515, N11HT700511516, N11HT700511517, N11HT700511518, N11HT700511519, N11HT700511521, N11HT700511530, N11HT700511533, N11HT700511534, N11HT700511536, N11HT700511538, N11HT700511541, N11HT700511542, N11HT700710477, N11HT700711735, N11HT700711737, N11HT700711738, N11HT700711739, N11HT700711740, N11HT700711742, N11HT700711748, N11HT700711751, N11HT700711753, N11HT700711754, N11HT700711755, N11HT700711756, N11HT700711757, N11HT700711758, N11HT700711760, N11HT700711761, N11HT700711764, N11HT700811824, N11HT700811825, N11HT700811826, N11HT700811852, N11HT700811853, N11HT700811855, N11HT700811856, N11HT700811859, N11HT700811860, N11HT700811862, N11HT700811863, N11HT700811865, N11HT700811866, N11HT700811870, N11HT700811876, N11HT700811877, N11HT700811878, N11HT700811880, N11HT700811881, N11HT700811882, N11HT700811885, N11HT700811893, N11HT700811894, N11HT700811895, N11HT700811896, N11HT700811897, N11HT700811899, N11HT700811905, N11HT700811906, N11HT700811907, N11HT700811909, N11HT700811910, N11HT700811911, N11HT700811912, N11HT700811913, N11HT700811915, N11HT700811916, N11HT700811917, N11HT700811918, N11HT700811919, N11HT700811920, N11HT700811921, N11HT700811922, N11HT700811924, N11HT700811926, N11HT700811927, N11HT700811928, N11HT700811931, N11HT700811932, N11HT700811933, N11HT700811934, N11HT700911991, N11HT701012653, N11HT701012654, N11HT701012655, N11HT701012665, N11HT701012666, N11HT701012667, N11HT701012678, N11HT701112715, N11HT701112716, N11HT701112717, N11HT701112725, N11HT701112727, N11HT701112728, N11HT701112729, N11HT701112733, N11HT701112736, N11HT701112737, N11HT701112738, N11HT701112739, N11HT701112744, N11HT701112746, N11HT701112747, N11HT701112748, N11HT701112749, N11HT701112750, N13HT700414744, N13HT700414754, N13HT700414755, N13HT700414756, N13HT700414757, N13HT700414758, N13HT700414760, N13HT700615023, N13HT701015203, N14HT700115373; HT70M-CN-NA/10884521542044/N11HT700411320, N11HT700511412, N15HT700617417, N15HT700617418, N15HT700617419, N15HT700917518, N15HT700917520, N15HT700917521, N17HT700117684, N17HT700117687, N17HT700117688, N17HT700117689, N17HT700117690, N17HT700117691, N17HT700117693, N17HT700117694, N17HT700117697, N17HT700117698, N17HT700117701, N17HT700117702, N17HT700117703, N17HT700117704, N17HT700117705, N17HT700117706, N17HT700117707, N17HT700117708, N17HT700117713, N17HT700117715, N17HT700117716, N17HT700117719, N17HT700117720, N17HT700117721, N17HT700117722, N17HT700217724, N17HT700217725, N17HT700217726, N17HT700217727, N17HT700217728, N17HT700217729, N17HT700217730, N17HT700217731, N17HT700217732, N17HT700217734, N17HT700217735, N17HT700217736, N17HT700517754, N17HT700517755, N17HT700517756, N17HT700517757, N17HT700517758, N17HT700517759, N17HT700517760, N17HT700517761, N17HT700517762, N17HT700517763, N17HT700517765, N17HT700517766, N17HT700517767, N17HT700517768, N17HT700517769, N17HT700517770, N17HT700517771, N17HT700517772, N17HT700517773, N17HT700517774, N17HT700517775, N17HT700517776, N17HT700517777, N17HT700517778, N17HT700517779, N17HT700517780, N17HT700517781, N17HT700517782, N17HT700517783, N17HT700517784, N17HT700517785, N17HT700517786, N17HT700517787, N17HT700517788, N17HT700517793, N17HT700517798, N17HT700517799, N17HT700517801, N17HT700617805, N17HT700617806, N17HT700617809, N17HT700617810, N17HT700617812, N17HT700617813, N17HT700617814, N17HT700617816, N17HT700617817, N17HT700617818, N17HT700617819, N17HT700617820, N17HT700617821, N17HT700617822, N17HT700617823, N17HT700617824, N17HT700617825, N17HT700617826, N17HT700617827, N17HT700617828, N17HT700617829, N17HT700617830, N17HT700617831, N17HT700617832, N17HT700617833, N17HT700617834, N17HT700617835, N17HT700617836, N17HT700617837, N17HT700617838, N17HT700617839, N17HT700617840, N17HT700617841, N17HT700617842, N17HT700617843, N17HT700617844, N17HT700617845, N17HT700617846, N17HT700617847, N17HT700617848, N17HT7006 …
Additional code information
N15HT721218865, N15HT721218866, N15HT721218870, N15HT721218874, N15HT721218876, N15HT721218877, N15HT721218878, N15HT721218880, N15HT721218883, N15HT721218885, N15HT721218891, N15HT721218892, N15HT721218893, N15HT721218894, N15HT721218895, N15HT721218897, N15HT721218898, N15HT721218899, N15HT721218900, N15HT721218901, N15HT721218902, N15HT721218903, N15HT721218904, N15HT721218905, N15HT721218906, N15HT721218907, N15HT721218908, N15HT721218909, N15HT721218910, N15HT721218911, N15HT721218912, N15HT721218913, N15HT721218914, N15HT721218915, N15HT721218916, N15HT721218917, N15HT721218918, N15HT721218919, N15HT721218920, N15HT721218921, N15HT721218922, N15HT721218923, N15HT721218924, N15HT721218925, N15HT721218926, N15HT721218927, N15HT721218928, N15HT721218929, N15HT721218930, N15HT721218931, N15HT721218932, N15HT721218933, N15HT721218934, N15HT721218935, N15HT721218936, N15HT721218937, N15HT721218938, N15HT721218939, N15HT721218940, N15HT721218941, N15HT721218943, N15HT721218944, N15HT721218945, N15HT721218946, N15HT721218947, N15HT721218948, N15HT721218949, N15HT721218950, N15HT721218951, N15HT721218952, N15HT721218953, N15HT721218954, N15HT721218955, N15HT721218957, N15HT721218958, N15HT721218959, N15HT721218960, N15HT721218961, N15HT721218962, N16HT720119011, N16HT720119012, N16HT720119013, N16HT720119014, N16HT720119015, N16HT720119016, N16HT720119017, N16HT720119018, N16HT720119019, N16HT720119021, N16HT720119022, N16HT720119023, N16HT720119024, N16HT720119025, N16HT720119026, N16HT720119027, N16HT720119028, N16HT720119029, N16HT720119030, N16HT720119031, N16HT720119032, N16HT720119033, N16HT720119034, N16HT720119035, N16HT720119036, N16HT720119037, N16HT720119038, N16HT720119039, N16HT720119040, N16HT720119041, N16HT720119042, N16HT720119043, N16HT720119044, N16HT720119045, N16HT720119046, N16HT720219093, N16HT720219094, N16HT720219095, N16HT720219096, N16HT720219097, N16HT720219098, N16HT720219099, N16HT720219100, N16HT720219101, N16HT720219102, N16HT720219103, N16HT720219104, N16HT720219106, N16HT720219107, N16HT720219108, N16HT720219109, N16HT720219110, N16HT720219111, N16HT720219112, N16HT720219113, N16HT720219114, N16HT720219115, N16HT720219116, N16HT720219117, N16HT720219118, N16HT720219119, N16HT720219121, N16HT720219122, N16HT720219123, N16HT720219124, N16HT720219125, N16HT720219126, N16HT720219127, N16HT720219128, N16HT720219129, N16HT720219130, N16HT720219131, N16HT720219132, N16HT720219133, N16HT720219134, N16HT720219135, N16HT720219136, N16HT720219137, N16HT720219138, N16HT720219139, N16HT720219140, N16HT720219141, N16HT720219142, N16HT720219143, N16HT720219144, N16HT720219145, N16HT720219146, N16HT720219147, N16HT720219148, N16HT720219149, N16HT720219150, N16HT720219151, N16HT720219152, N16HT720319185, N16HT720319186, N16HT720319187, N16HT720319188, N16HT720319189, N16HT720319190, N16HT720319195, N16HT720319197, N16HT720319199, N16HT720319200, N16HT720319201, N16HT720319207, N16HT720319209, N16HT720319210, N16HT720319211, N16HT720319212, N16HT720319213, N16HT720319214, N16HT720319215, N16HT720319216, N16HT720319217, N16HT720319218, N16HT720319219, N16HT720319222, N16HT720319223, N16HT720319224, N16HT720319226, N16HT720319227, N16HT720319228, N16HT720319229, N16HT720319230, N16HT720319233, N16HT720319234, N16HT720319235, N16HT720319236, N16HT720319237, N16HT720319238, N16HT720319239, N16HT720319240, N16HT720319241, N16HT720319242, N16HT720319243, N16HT720319244, N16HT720319245, N16HT720319246, N16HT720319247, N16HT720319248, N16HT720319249, N16HT720319250, N16HT720319251, N16HT720319252, N16HT720319253, N16HT720319254, N16HT720319255, N16HT720319256, N16HT720319257, N16HT720319258, N16HT720319259, N16HT720319260, N16HT720319261, N16HT720319262, N16HT720319263, N16HT720319264, N16HT720319266, N16HT720319267, N16HT720319268, N16HT720319270, N16HT720319272, N16HT720319273, N16HT720319274, N16HT720319275, N16HT720319276, N16HT720319277, N16HT720319278, N16HT720319279, N16HT720319280, N16HT720319281, N16HT720319282, N16HT720319283, N16HT720319284, N16HT720319286, N16HT720319287, N16HT720319288, N16HT720419443, N16HT720419444, N16HT720419445, N16HT720419446, N16HT720419448, N16HT720419449, N16HT720419450, N16HT720419451, N16HT720419452, N16HT720419453, N16HT720419454, N16HT720419455, N16HT720419456, N16HT720419457, N16HT720419458, N16HT720419459, N16HT720419460, N16HT720419461, N16HT720419462, N16HT720419463, N16HT720419464, N16HT720419465, N16HT720419466, N16HT720419467, N16HT720419468, N16HT720419469, N16HT720419470, N16HT720419471, N16HT720419472, N16HT720419473, N16HT720419478, N16HT720419479, N16HT720419480, N16HT720419481, N16HT720419482, N16HT720419483, N16HT720419485, N16HT720419489, N16HT720419490, N16HT720419491, N16HT720419493, N16HT720419494, N16HT720419495, N16HT720419498, N16HT720419500, N16HT720419501, N16HT720419502, N16HT720419505, N16HT720419506, N16HT720419507, N16HT720419509, N16HT720419510, N16HT720419511, N16HT720419513, N16HT720419514, N16HT720419515, N16HT720419516, N16HT720419520, N16HT720419521, N16HT720419523, N16HT720419525, N16HT720419526, N16HT720419530, N16HT720519531, N16HT720519533, N16HT720519534, N16HT720519535, N16HT720519537, N16HT720519539, N16HT720519540, N16HT720519541, N16HT720519542, N16HT720519549, N16HT720519551, N16HT720519552, N16HT720519554, N16HT720519555, N16HT720519556, N16HT720519557, N16HT720519559, N16HT720519560, N16HT720519561, N16HT720519562, N16HT720519563, N16HT720519564, N16HT720519566, N16HT720519567, N16HT720519568, N16HT720519569, N16HT720519571, N16HT720519573, N16HT720519575, N16HT720519576, N16HT720519577, N16HT720519578, N16HT720519580, N16HT720519581, N16HT720519582, N16HT720519583, N16HT720519585, N16HT720519586, N16HT720519587, N16HT720519590, N16HT721019662, N16HT721019664, N16HT721019671, N16HT721019677, N16HT721019678, N16HT721019683, N16HT721019684, N16HT721019685, N16HT721019686, N16HT721019687, N16HT721019688, N16HT721019689, N16HT721019690, N16HT721019691, N16HT721019692, N16HT721019693, N16HT721019694, N16HT721019695, N16HT721019696, N16HT721019697, N16HT721019698, N16HT721019699, N16HT721019700, N16HT721019701, N16HT721019702, N16HT721019703, N16HT721019704, N16HT721019705, N16HT721019706, N16HT721019707, N16HT721019708, N16HT721019709, N16HT721019710, N16HT721019711, N16HT721019712, N16HT721019714, N16HT721019715, N16HT721019716, N16HT721019717, N16HT721019718, N16HT721019719, N16HT721019720, N16HT721019721, N16HT721019722, N16HT721019723, N16HT721019724, N16HT721019725, N16HT721019726, N16HT721119727, N16HT721119728, N16HT721119729, N16HT721119730, N16HT721119731, N16HT721119732, N16HT721119734, N16HT721119735, N16HT721119736, N16HT721119738, N16HT721119739, N16HT721119740, N16HT721119741, N16HT721119742, N16HT721119743, N16HT721119744, N16HT721119745, N16HT721119746, N16HT721119748, N16HT721119749, N16HT721119750, N16HT721119751, N16HT721119752, N16HT721119753, N16HT721119755, N16HT721119756, N16HT721119757, N16HT721119760, N16HT721119763, N16HT721119764, N16HT721119765, N16HT721119766, N16HT721119767, N16HT721119768, N16HT721119769, N16HT721119770, N16HT721119771, N16HT721119773, N16HT721119774, N16HT721119775, N16HT721119776, N16HT721119777, N16HT721119778, N16HT721119779, N16HT721119780, N16HT721119781, N16HT721119782, N16HT721119783, N16HT721119784, N16HT721119785, N16HT721119786, N16HT721219787, N16HT721219788, N16HT721219789, N16HT721219790, N16HT721219791, N16HT721219792, N16HT721219793, N16HT721219794, N16HT721219795, N16HT721219796, N16HT721219797, N16HT721219798, N16HT721219799, N16HT721219800, N16HT721219801, N16HT721219802, N16HT721219803, N16HT721219804, N16HT721219805, N16HT721219806, N16HT721219807, N16HT721219808, N16HT721219809, N16HT721219810, N16HT721219811, N16HT721219812, N16HT721219813, N16HT721219814, N16HT721219815, N16HT721219816, N16HT721219817, N16HT721219818, N16HT721219819, N16HT721219820, N16HT721219821, N16HT721219822, N16HT721219824, N16HT721219825, N16HT721219826, N16HT721219827, N16HT721219828, N16HT721219829, N16HT721219830, N16HT721219831, N16HT721219832, N16HT721219833, N16HT721219834, N16HT721219835, N16HT721219836, N16HT721219837, N16HT721219838, N16HT721219839, N16HT721219840, N16HT721219841, N16HT721219844, N16HT721219846, N16HT721219847, N16HT721219850, N16HT721219851, N16HT721219853, N16HT721219854, N16HT721219855, N16HT721219856, N16HT721219857, N16HT721219858, N16HT721219859, N16HT721219861, N16HT721219862, N16HT721219863, N16HT721219867, N16HT721219868, N16HT721219869, N16HT721219870, N16HT721219871, N16HT721219872, N16HT721219873, N16HT721219874, N16HT721219875, N16HT721219876, N17HT720119877, N17HT720119878, N17HT720119879, N17HT720119880, N17HT720119881, N17HT720119882, N17HT720119883, N17HT720119884, N17HT720119885, N17HT720119886, N17HT720119887, N17HT720119888, N17HT720119889, N17HT720119890, N17HT720119891, N17HT720119892, N17HT720119893, N17HT720119894, N17HT720119895, N17HT720119896, N17HT720119897, N17HT720119898, N17HT720119899, N17HT720119900, N17HT720119901, N17HT720119902, N17HT720119903, N17HT720119904, N17HT720119905, N17HT720119906, N17HT720119907, N17HT720119908, N17HT720119909, N17HT720119910, N17HT720119911, N17HT720119913, N17HT720119914, N17HT720119915, N17HT720119916, N17HT720119917, N17HT720119918, N17HT720119919, N17HT720119920, N17HT720119921, N17HT720119923, N17HT720119924, N17HT720119925, N17HT720119927, N17HT720119929, N17HT720119930, N17HT720119931, N17HT720119932, N17HT720119933, N17HT720119934, N17HT720119935, N17HT720119936, N17HT720119937, N17HT720420296, N17HT720520297, N17HT720520298, N17HT720520299, N17HT720520300, N17HT720520301, N17HT720520302, N17HT720520303, N17HT720520304, N17HT720520305, N17HT720520306, N17HT720520307, N17HT720520308, N17HT720520309, N17HT720520310, N17HT720520311, N17HT720520313, N17HT720520314, N17HT720520315, N17HT720520316, N17HT720520317, N17HT720520318, N17HT720520319, N17HT720520320, N17HT720520321, N17HT720520323, N17HT720520324, N17HT720520325, N17HT720520326, N17HT720520327, N17HT720520328, N17HT720520329, N17HT720520330, N17HT720520331, N17HT720520332, N17HT720520335, N17HT720520337, N17HT720520338, N17HT720520340, N17HT720520341, N17HT720520343, N17HT720520344, N17HT720520348, N17HT720520349, N17HT720520351, N17HT720520352, N17HT720520354, N17HT720520356, N17HT720520359, N17HT720520360, N17HT720520361, N17HT720620362, N17HT720620366, N17HT720620370, N17HT720620371, N17HT720620378, N17HT720620379, N17HT720620382, N17HT720620384, N17HT720620389, N17HT720620392, N17HT720620393, N17HT720620395, N17HT720620396, N17HT720620397, N17HT720620401, N17HT720620402, N17HT720620403, N17HT720620404, N17HT720620405, N17HT720620406, N17HT720720433, N17HT720720437, N17HT720720441, N17HT720720442, N17HT720720449, N17HT720720456, N17HT720720457, N17HT720720462, N17HT720720463, N17HT720720464, N17HT720720465, N17HT720720468, N17HT720720469, N17HT720720471, N17HT720720472, N17HT720720473, N17HT720720475, N17HT720720478, N17HT720720480, N17HT720720483, N17HT720720484, N17HT720720485, N17HT720720486, N17HT720720487, N17HT720720488, N17HT720720494, N17HT720720496, N17HT720720499, N17HT720720502, N17HT720820625, N17HT720820658, N17HT720820659, N17HT720820683, N17HT720820708, N17HT720920761, N17HT720920762, N17HT720920764, N17HT720920765, N17HT720920766, N17HT720920767, N17HT720920769, N17HT720920771, N17HT720920772, N17HT720920776, N17HT720920777, N17HT720920778, N17HT720920779, N17HT720920780, N17HT720920781, N17HT720920785, N17HT720920786, N17HT720920787, N17HT720920791, N17HT720920795, N17HT720920796, N17HT720920797, N17HT720920800, N17HT720920801, N17HT720920802, N17HT720920803, N17HT720920804, N17HT720920805, N17HT720920809, N17HT720920810, N17HT720920812, N17HT720920813, N17HT720920814, N17HT720920815, N17HT720920816, N17HT720920817, N17HT720920818, N17HT720920819, N17HT720920820, N17HT720920821, N17HT720920822, N17HT720920823, N17HT720920824, N17HT720920825, N17HT720920826, N17HT720920827, N17HT720920828, N17HT720920829, N17HT720920830, N17HT720920831, N17HT720920832, N17HT720920833, …
What the firm is doing
On 05/21/2025 recall notices were mailed and/or emailed customers who were asked to do the following: Healthcare providers with patients currently ventilated with affected ventilators should assess overall risk and appropriate timing for device replacement. - A patient connected to a ventilator requires the constant attention of trained caregivers to the patient's condition. - Always have an alternate power source and means of ventilation available when the ventilator is in use. - Always use appropriate monitors to ensure sufficient oxygenation and ventilation when the ventilator is in use. - If, at any time, the patient is not responding to ventilation appropriately, the patient should be taken off the ventilator immediately and connected to an alternate method of ventilation. Contact the patient's health care provider/physician immediately. - Follow Patient Set-up Procedure described in Operator's Manuals to verify the shutdown alert alarm's functionality prior to use. Medtronic is not correcting these issues on affected ventilators or service parts and will no longer service affected ventilators identified in this notification. -If affected ventilator or service part is currently in use, remove and replace it with an alternate means of ventilation. After completing the transition, quarantine all affected ventilators and service parts and follow your facility's processes for removal and disposal. Patients are asked to return affected devices to their healthcare provider. Complete/return the Acknowledgement Form via email to rs.gmbmitgfca@medtronic.com. Questions or concerns contact firm's Technical Service at 1-800-255-6774 Distribute notice to all relevant personnel within your organization and any organizations where ventilators or service parts may have been transferred or distributed. Provide the enclosed patient letter to any of your patients using this ventilator in the home care setting to inform them of this recall.
DistributionShow detailsHide
Worldwide - US Nationwide distribution including in the states of MA, CT, KS, OH, PR, NH, GA, WI, MS, VA, CO, TX, MN, AL, IA, NY, UT, NM, KY, RI, SD, PA, IA, CA, MO, HI, MI, IL, MT, NJ, TN, SC, FL, IN, AZ, ID, LA, WA, NC, MD, WY, NE, NV, ND, ME, AK, DE, OK, OR and the countries of Japan, Canada, Singapore, Lithuania, Kazakhstan, Slovenia, Colombia, China, Qatar, United Arab Emirates, Greece, Saudi Arabia, Nigeria, Romania, Netherlands, Lebanon, Oman, Jordan, Malawi, India, Croatia, Portugal, Turkey, Brazil, Pakistan, Trinidad and Tobago, Slovakia, Chile, Egypt, Switzerland, South Africa, Thailand, Bangladesh, Myanmar, Peru, Uruguay, Hungary, Argentina, Iran, Islamic Republic Of, Costa Rica, Vietnam, Australia, Guatemala, Mexico, Guyana, Jamaica, Dominican Republic, Bahamas, Bosnia and Herzegovina, South Korea, Tunisia, Ukraine, Uzbekistan, Indonesia, Burkina Faso, Italy, Panama, Sri Lanka, Malaysia, Namibia, Swaziland, Spain, Philippines, Bhutan, Mauritius, Poland, France, Cambodia, Czechia, Israel, Norway, Russian Federation, United Kingdom, Canary Islands, Kenya, Czech Republic, Croatia , Estonia, Maldova, Palestine.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1915-2025
- FDA 510(k) clearance · K111146The device's official FDA premarket clearance record
- FDA device classification · CBKOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5895The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find CovidienSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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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