Recall archive / FDA device enforcement
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-... — FDA record Z-1915-2025
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 May 21, 2025. 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
- Newport HT70 Ventilator, REF: 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, REF: 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-WW-NA. HT70-2 CONTROL BOARD ROHS, REF: GR-PCB3252A. HT70-2 CONTROL BOARD ROHS X1, REF: GR105796. HT70P CONTROL BOARD ROHS X1, REF: GR105795. HT70 Conversion Kit, REF: GRFSKHT70M-2.
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Covidien
- Quantity
- 5394
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1915-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | REF/UDI-DI/Serial Numbers: 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, N17HT700617849, N17HT700617850, N17HT700617851, N17HT700617852, N17HT700617853, N17HT700717870, N17HT700717875, N17HT700717876, N17HT700817941, N17HT700817960, N17HT701118024, N17HT701118025, N17HT701118026, N17HT701118027, N17HT701118028, N17HT701118030, N17HT701118031, N17HT701118033, N17HT701118034, N17HT701118035, N17HT701118036, N17HT701118037, N17HT701118038, N17HT701118039, N17HT701118040, N17HT701118041, N17HT701118042, N17HT701118043, N17HT701118044, N17HT701118045, N17HT701118046, N17HT701118047, N17HT701118048, N17HT701118049, N17HT701118050, N17HT701118051, N17HT701118052, N17HT701118053, N17HT701118054, N17HT701118055, N17HT701118056, N17HT701218057, N17HT701218058, N17HT701218059, N17HT701218060, N17HT701218061, N17HT701218062, N17HT701218063, N17HT701218064, N17HT701218065, N17HT701218066, N17HT701218067, N17HT701218068, N17HT701218070, N17HT701218071, N17HT701218072, N17HT701218073, N17HT701218074, N17HT701218075, N17HT701218076, N18HT700318079, N18HT700318086, N18HT700318087, N18HT700318090, N18HT700318091, N18HT700318095, N18HT700318096, N18HT700318101, N18HT700318104, N18HT700318106; HT70M-ES-EU/10884521542051/N11HT700611687, N11HT701212761, N11HT701212812, N14HT700315507, N14HT701117097, N14HT701117101, N14HT720113030, N15HT720716832, N15HT720716835, N15HT720716841, N15HT720716842, N15HT720716843, N15HT720716844, N15HT720716850, N15HT720716854, N15HT720716855, N15HT720716870, N15HT720718413, N15HT720718414, N15HT720718415, N15HT720718416, N15HT720816898, N15HT720816899, N15HT720816900, N15HT720816903, N15HT720816905, N15HT720918562, N15HT720918563, N16HT720119048, N16HT720119049, N16HT720119050, N16HT720119054, N16HT720119055, N16HT720119056, N16HT720119059, N16HT720119060, N16HT720219091, N16HT720319290, N16HT720319291, N16HT720319292, N16HT720319293, N16HT720319295, N16HT720319296, N16HT720319298, N16HT720319300, N16HT720319302, N16HT720319307, N16HT720319310, N16HT720319311, N16HT720319323, N16HT720319325, N16HT720319328, N16HT720319329, N16HT720319330, N16HT720319331, N16HT720319332, N16HT720319333, N16HT720319334, N16HT720319336, N16HT720319338, N16HT720319339, N16HT720319340, N16HT720319341, N16HT720319342, N16HT720319347, N16HT720319348, N16HT720319352, N16HT720319355, N16HT720319356, N16HT720319357, N16HT720319358, N16HT720319361, N16HT720319370, N16HT720319387, N16HT720319391, N16HT720319409, N16HT720319410, N16HT720319412, N16HT720319413, N16HT720319414, N16HT720319415, N16HT720319416, N16HT720319418, N16HT720319419, N16HT720319420, N16HT720319421, N16HT720319423, N16HT720319425, N16HT720919639, N16HT720919640, N16HT720919643, N16HT720919644, N16HT720919650, N16HT720919651, N16HT720919652, N16HT720919653; HT70M-PT-BR/10884521542082/N15HT720718399; HT70M-SY-EU/10884521542105/N10HT700510067, N10HT700510082, N10HT701111020, N10HT701111045, N10HT701111051, N11HT700710475, N11HT700710476, N11HT700811936, N13HT700113346, N15HT700417351, N15HT700417360, N15HT700417364, N15HT700717422, N15HT700717425, N15HT700817448, N15HT700817451, N15HT700817452, N15HT700817453, N15HT700817454, N15HT700817455, N15HT700817456, N15HT700817457, N15HT700817490, N15HT700817492, N15HT700817493, N15HT700817496, N15HT700817497, N15HT700917498, N15HT700917499, N15HT700917538, N15HT700917539, N15HT700917540, N15HT700917541, N15HT700917542, N15HT700917543, N15HT700917544, N15HT721118767, N16HT700917615, N16HT700917617, N16HT701017619, N16HT701017626, N16HT701017627, N16HT701017628, N16HT701017629, N16HT701017630, N16HT701017632, N16HT701017633, N16HT701017634, N16HT701017635, N16HT701017636, N16HT701017637, N16HT701017639, N16HT701017640, N16HT701017643, N16HT701117660, N16HT701117661, N16HT701217665, N16HT701217667, N16HT701217668, N16HT701217669, N16HT701217673, N16HT701217674, N16HT701217677, N16HT701217678, N16HT701217679, N16HT701217680, N16HT701217682, N16HT701217683, N17HT700817926; HT70M-WW-EU/10884521542136/N11HT700911944, N12HT720810474; HT70M-WW-NA/10884521542143/HT72160001, HT72160002, HT72160004, HT72160005, HT72160007, HT72160011, HT72160012, HT72160017, HT72160020, HT72160023, HT72160025, N10HT700510066, N10HT700710165, N10HT700810184, N11HT700111140, N11HT700311180, N11HT700311181, N11HT700411323, N11HT700411331, N11HT700411341, N11HT700411363, N11HT700411365, N11HT700511543, N11HT700511548, N11HT700611663, N11HT700811830, N11HT700811836, N11HT700811867, N11HT700910512, N11HT700911939, N11HT700911952, N11HT701112548, N12HT700112820, N12HT700214024, N12HT700412951, N13HT700214668, N15HT700517371, N15HT700517410, N15HT700517411, N15HT700616204, N15HT700616206, N15HT700616207, N15HT700616208, N15HT700616210, N15HT700616211, N15HT700616212, N15HT700616213, N15HT700616214, N15HT700616217, N15HT700616219, N15HT700616220, N15HT700616222, N15HT700716255, N15HT700716256, N15HT700716258, N15HT700716259, N15HT700716260, N15HT700716263, N15HT700716264, N15HT700716267, N15HT700717427, N15HT700717428, N15HT700717429, N15HT700717430, N15HT700717431, N15HT700717435, N15HT700717436, N15HT700817441, N15HT700817445, N15HT700817446, N15HT700817447, N15HT700817468, N15HT700817469, N15HT700817472, N15HT700817473, N15HT700817474, N15HT700817476, N15HT700817477, N15HT700817478, N15HT700817479, N15HT700817480, N15HT700817481, N15HT700817482, N15HT700817483, N15HT700817484, N15HT700817485, N15HT700817486, N15HT700917502, N15HT700917505, N15HT700917508, N15HT700917509, N15HT701117593; HT70-SY-EU/10884521544178/N10HT700510068 N10HT701111023, N10HT700510072 N10HT701111027, N10HT700510073 N10HT701111028, N10HT700510074 N10HT701111029, N10HT700510083 N11HT700110379, N10HT700510084. HT70PM-ES-EU/10884521542174, 10884521544291/HT7P150048, HT7P150236, HT7P150381, HT7P150397, HT7P150434, HT7P150440, HT7P150446, HT7P150455, HT7P150457, HT7P150469, HT7P150470, HT7P150471, HT7P150473, HT7P150479, HT7P150522, HT7P150529, HT7P150531, HT7P150532, HT7P150537, HT7P150539, HT7P150541, HT7P150547, HT7P150548, HT7P150554, HT7P150663, HT7P160032, HT7P160033, HT7P160043, HT7P160049, HT7P160073, HT7P1700... |
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
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 18, 2025
- Recall initiation date
- May 21, 2025
- Center classification date
- Jun 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.