Fresh Recalls

FDAClass II · Medical device · Recall Z-3238-2026 · Recalled September 30, 2026

Ingenia 3 recall — Philips North America Llc

Agency report date: September 30, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Ingenia 3
Company / brand
Philips North America
Lot / serial / date codes
1. Model Numbers (REF): 781342(3.0T); UDI-DI: 884838055339; Serial Numbers: 85106, 71152, 71526, 71812, 71179, 71252, 71328, 71342, 71419, 71550, 71551, 71555, 71557, 71674, 71693, 71949, 85036, 85155, 71266, 71345, 71392, 71395, 71628, 85393, 71216, 71651, 85208, 71163, 71408, 71499, 71541, 71668, 71771, 71602, 71260, 71276, 71324, 71726, 71068, 71300, 71482, 71339, 71452, 71464, 71465, 71468, 71470, 71471, 71472, 71473, 71479, 71480, 71492, 71497, 71506, 71509, 71511, 71514, 71516, 71517, 71519, 71520, 71548, 71553, 71554, 71559, 71560, 71567, 71588, 71596, 71601, 71605, 71609, 71614, 71621, 71622, 71624, 71626, 71629, 71631, 71633, 71637, 71642, 71653, 71654, 71685, 71687, 71690, 71692, 71695, 71698, 71699, 71702, 71707, 71708, 71709, 71713, 71714, 71716, 71734, 71738, 71744, 71755, 71765, 71775, 71779, 71783, 71784, 71786, 71788, 71804, 71807, 71814, 71818, 71819, 71820, 71821, 71834, 71839, 71840, 71856, 71861, 71868, 71872, 71875, 71876, 71877, 71894, 71898, 71908, 71913, 71917, 71928, 71930, 71935, 71944, 71946, 71951, 71952, 71957, 71958, 71973, 71987, 71988, 85010, 85024, 85026, 85028, 85037, 85042, 85048, 85049, 85050, 85061, 85065, 85073, 85075, 85079, 85096, 85098, 85099, 85105, 85111, 85112, 85127, 85141, 85152, 85153, 85160, 85162, 85168, 85169, 85170, 85171, 85172, 85174, 85177, 85178, 85184, 85198, 85200, 85204, 85218, 85220, 85226, 85230, 85242, 85243, 85247, 85249, 85251, 85259, 85263, 85268, 85269, 85270, 85272, 85280, 85282, 85283, 85284, 85285, 85288, 85290, 85291, 85294, 85300, 85303, 85305, 85309, 85310, 85311, 85313, 85314, 85323, 85325, 85329, 85332, 85333, 85334, 85335, 85336, 85339, 85344, 85345, 85346, 85349, 85350, 85351, 85353, 85354, 85355, 85356, 85357, 85358, 85359, 85360, 85361, 85362, 85364, 85369, 85370, 85371, 85373, 85374, 85375, 85376, 85380, 85382, 85383, 85384, 85385, 85386, 85387, 85389, 85390, 85392, 85397, 85398, 85399, 85401, 85402, 85403, 85406, 85407, 85408, 85412, 85413, 85415, 85416, 85417, 85418, 85419, 85420, 85422, 85425, 85426, 85427, 85429, 85430, 85431, 85432, 85433, 85434, 85439, 85440, 85442, 85447, 85448, 85449, 85453, 85454, 85455, 85456, 85457, 85458, 85460, 85461, 85462, 85463, 85466, 85467, 85468, 85469, 85470, 85471, 85476, 85478, 85479, 85480, 85481, 85483, 85484, 85485, 85487, 85488, 85490, 85491, 85494, 85496, 85497, 85498, 85499, 85501, 85504, 85506, 85507, 85509, 85510, 85515, 85517, 85518, 85519, 85522, 85524, 85525, 85526, 85527, 85528, 85531, 85532, 85533, 85535, 71372, 71649, 71581, 71582, 71748, 85143, 71405, 71373, 85265, 71047, 71662, 71678, 71891, 85189, 71267, 71353, 71402, 71457, 85450, 85451, 71474, 71338, 71418, 71924, 71991, 85202, 85306, 71437, 71003, 71020, 71023, 71173, 71192, 71283, 71288, 71298, 71315, 71337, 71359, 71363, 71370, 71396, 71400, 71440, 71501, 71576, 71590, 71603, 71751, 71791, 71838, 71874, 85025, 85161, 85253, 85301, 85319, 85342, 85391, 71346, 71362, 71910, 71983, 85063, 85183, 85205, 85206, 85216, 85341, 71334, 71409, 71476, 85023, 71061, 71106, 71162, 71165, 71181, 71280, 71349, 71351, 71357, 71410, 71428, 71460, 71477, 71512, 71518, 71643, 71677, 71691, 71717, 71743, 71750, 71762, 71763, 71842, 71854, 71900, 71966, 71967, 85122, 85140, 85147, 85149, 85190, 85203, 85210, 85224, 85318, 71367, 71461, 71545, 85241, 85302, 85348, 85372, 85459, 71423, 71177, 71326, 71424, 71681, 71758, 71863, 71892, 85057, 85245, 85246, 85250, 85286, 71001, 71002, 71004, 71007, 71012, 71013, 71014, 71035, 71037, 71039, 71056, 71070, 71093, 71095, 71154, 71155, 71174, 71175, 71183, 71211, 71228, 71268, 71269, 71282, 71341, 71347, 71361, 71401, 71411, 71413, 71416, 71425, 71429, 71450, 71463, 71489, 71498, 71527, 71571, 71587, 71589, 71592, 71635, 71641, 71652, 71655, 71659, 71670, 71676, 71682, 71686, 71694, 71760, 71766, 71767, 71772, 71778, 71801, 71802, 71825, 71844, 71851, 71864, 71869, 71878, 71879, 71880, 71881, 71882, 71897, 71972, 71992, 85022, 85038, 85064, 85069, 85074, 85076, 85083, 85121, 85124, 85217, 85377, 85378, 85381, 85396, 85400, 71086, 71343, 71671, 71679, 85428, 71107, 85166, 71058, 71078, 71176, 71263, 71299, 71307, 71321, 71387, 71575, 71625, 71640, 71799, 71852, 85181, 85187, 85312, 85330, 85365, 71172, 71195, 71790, 71948, 71996, 85004, 85136, 85223, 85317, 85109, 71956, 85232, 85304, 85021, 71159, 71364, 71380, 71563, 71953, 71170, 71296, 71781, 85213, 71097, 71722, 71335, 71919, 85148, 85367, 71302, 85366, 71150, 71188, 71225, 71360, 71634, 71665, 71884, 85009, 71510, 71746, 85018, 71648, 85236, 85260, 85368, 71220, 71227, 71272, 71350, 71451, 71522, 71700, 85012, 85054, 85316, 85388, 85414, 71077, 71204, 71365, 71398, 85091, 71478, 71618, 71826, 71669, 71764, 71833, 71867, 71270, 71051, 71231, 71604, 71650, 71689, 71823, 71895, 85059, 85321, 85340, 71600, 71848, 71305, 71445, 71566, 71018, 71040, 71072, 71189, 71197, 71198, 71224, 71332, 71384, 71434, 71442, 71448, 71486, 71496, 71597, 71623, 71644, 71645, 71703, 71706, 71737, 71752, 71871, 85081, 85114, 85142, 71314, 71583, 71808, 71916, 71291, 71304, 71368, 71371, 71711, 71756, 71822, 71860, 71911, 71931, 71936, 85123, 85125, 85185, 85193, 71333, 71377, 71386, 71524, 71785, 71789, 71986, 85019, 85209, 85295, 85322, 71352, 71426, 71977, 85020, 71215, 71285, 71287, 71308, 71318, 71354, 71459, 71490, 71534, 85101, 71010, 71016, 71022, 71029, 71045, 71062, 71064, 71065, 71071, 71073, 71153, 71187, 71190, 71194, 71200, 71203, 71213, 71275, 71277, 71317, 71319, 71331, 71336, 71369, 71376, 71379, 71382, 71388, 71397, 71399, 71407, 71415, 71444, 71456, 71483, 71495, 71528, 71529, 71569, 71570, 71584, 71599, 71667, 71675, 71680, 71683, 71721, 71732, 71735, 71796, 71805, 71810, 71827, 71829, 71858, 71893, 71914, 71982, 85067, 85094, 85154, 85221, 85275, 85278, 85436, 71436, 85222, 71544; 2. Model Numbers (REF): 781377(3.0T); UDI-DI: 884838009813; Serial Numbers: 42175, 42190, 42221, 42231, 42283, 42291, 42339, 42439, 42466, 42186, 42147, 42171, 42183, 42206, 42213, 42448, 42243, 42251, 42280, 42326, 42343, 42362, 42367, 42380, 42398, 42436, 42444, 42445, 42446, 42452, 42453, 42454, 42458, 42459, 42463, 42469, 42490, 42491, 42492, 42493, 42494, 42495, 42496, 42499, 42500, 42502, 42504, 42505, 42506, 42507, 42508, 42510, 42512, 42520, 42522, 42525, 42528, 42530, 42531, 42545, 42546, 42547, 42548, 42549, 42552, 42553, 42554, 42555, 42556, 42557, 42558, 42560, 42561, 42565, 42570, 42042, 42239, 42178, 42041, 42092, 42005, 42013, 42015, 42021, 42027, 42028, 42061, 42073, 42081, 42082, 42090, 42097, 42107, 42130, 42138, 42141, 42143, 42145, 42216, 42279, 42292, 42315, 42044, 42089, 42232, 42272, 42026, 42047, 42110, 42146, 42191, 42192, 42285, 42364, 42407, 42426, 42136, 42137, 42199, 42275, 42014, 42056, 42074, 42093, 42095, 42103, 42112, 42115, 42121, 42128, 42133, 42161, 42162, 42179, 42203, 42205, 42222, 42233, 42237, 42245, 42249, 42252, 42253, 42257, 42260, 42261, 42262, 42263, 42278, 42282, 42289, 42300, 42309, 42314, 42331, 42333, 42337, 42345, 42347, 42349, 42361, 42378, 42383, 42392, 42412, 42420, 42421, 42422, 42432, 42442, 42428, 42087, 42120, 42170, 42201, 42267, 42401, 42449, 42294, 42019, 42390, 42451, 42135, 42209, 42008, 42236, 42353, 42355, 42455, 42256, 42043, 42438, 42265, 42321, 42018, 42012, 42065, 42079, 42132, 42134, 42176, 42303, 42338, 42399, 42419, 42264, 42131, 42204, 42055, 42220, 42358, 42413, 42001, 42006, 42034, 42036, 42038, 42040, 42045, 42050, 42052, 42053, 42067, 42068, 42076, 42083, 42096, 42099, 42100, 42101, 42102, 42111, 42116, 42117, 42119, 42123, 42150, 42152, 42169, 42177, 42180, 42185, 42214, 42229, 42240, 42241, 42242, 42247, 42266, 42274, 42286, 42298, 42307, 42328, 42334, 42356, 42365, 42368, 42370, 42389, 42400, 42429, 42077, 42066; 3. Model Numbers (REF): 782103(3.0T); UDI-DI: 884838098299; Serial Numbers: 85724, 85667, 85622, 85625, 85626, 85628, 85629, 85630, 85631, 85633, 85636, 85637, 85638, 85641, 85642, 85650, 85656, 85657, 85658, 85659, 85660, 85662, 85692, 85710, 85715, 85721, 85722, 85725, 85727, 85729, 85735, 85738, 85739, 85740, 85743, 85745, 85746, 85747, 85748, 85749, 85756, 85696, 85620, 85608, 85614, 85755, 85672, 85673, 85674, 85720, 85730, 85732, 85762, 85693, 85619, 85718, 85600, 85607, 85616, 85617, 85707, 85613, 85611, 85612, 85615, 85703, 85719, 85666, 85664, 85700, 85643, 85644, 85761; 4. Model Numbers (REF): 781271(3.0T CX); UDI-DI: 884838068452; Serial Numbers: 78121, 78150, 78157, 78096, 78012, 78074, 78154, 78161, 78170, 78171, 78172, 78173, 78182, 78183, 78189, 78190, 78196, 78198, 78205, 78210, 78212, 78213, 78216, 78218, 78221, 78225, 78240, 78242, 78243, 78244, 78250, 78251, 78252, 78253, 78256, 78257, 78262, 78263, 78265, 78266, 78267, 78268, 78269, 78270, 78271, 78272, 78273, 78279, 78280, 78281, 78282, 78283, 78284, 78288, 78289, 78291, 78292, 78293, 78294, 78295, 78296, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78314, 78316, 78317, 78319, 78320, 78321, 78322, 78323, 78327, 78328, 78329, 78330, 78332, 78333, 78334, 78335, 78338, 78339, 78340, 78341, 78342, 78343, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78359, 78360, 78361, 78362, 78363, 78364, 78366, 78368, 78370, 78374, 78375, 78376, 78377, 78386, 78078, 78224, 78098, 78003, 78065, 78070, 78076, 78081, 78087, 78097, 78099, 78101, 78104, 78107, 78126, 78149, 78151, 78181, 78206, 78219, 78264, 78064, 78106, 78187, 78000, 78007, 78010, 78015, 78018, 78019, 78021, 78023, 78029, 78031, 78032, 78038, 78039, 78043, 78048, 78049, 78051, 78062, 78068, 78072, 78082, 78083, 78084, 78088, 78089, 78091, 78095, 78100, 78109, 78111, 78117, 78127, 78129, 78132, 78133, 78139, 78140, 78155, 78203, 78207, 78214, 78222, 78223, 78011, 78013, 78014, 78034, 78044, 78046, 78047, 78058, 78060, 78066, 78071, 78073, 78075, 78077, 78086, 78092, 78102, 78110, 78118, 78120, 78128, 78135, 78137, 78138, 78141, 78142, 78158, 78162, 78164, 78180, 78188, 78193, 78194, 78209, 78215, 78227, 78232, 78234, 78247, 78254, 78255, 78261, 78277, 78290, 78297, 78298, 78299, 78326, 78337, 78004, 78030, 78059, 78156, 78249, 78026, 78022; 5. Model Numbers (REF): 782105(3.0T CX); UDI-DI: 884838098312; Serial Numbers: 78516, 78517, 78518, 78519, 78521, 78522, 78523, 78524, 78525, 78526, 78527, 78528, 78529, 78530, 78531, 78536, 78537, 78539, 78545, 78546, 78547, 78548, 78549, 78550, 78551, 78553, 78554, 78555, 78556, 78557, 78558, 78559, 78560, 78561, 78562, 78564, 78565, 78567, 78570, 78571, 78573, 78574, 78500, 78501, 78503, 78504, 78505, 78507, 78508, 78512, 78513, 78532, 78535, 78538, 78540, 78541, 78542, 78543, 78544, 78552, 78566, 78568;
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;
Agency product description and boundaries

Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Ingenia 3 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-3238-2026
Brand
All Philips North America recalls
Classification
Class II
Units affected
1,447
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Cambridge, MA, United States
Firm address
222 Jacobs St, 02141-2289

Identifying details (verbatim from the notice)

Product codes / lots
1. Model Numbers (REF): 781342(3.0T); UDI-DI: 884838055339; Serial Numbers: 85106, 71152, 71526, 71812, 71179, 71252, 71328, 71342, 71419, 71550, 71551, 71555, 71557, 71674, 71693, 71949, 85036, 85155, 71266, 71345, 71392, 71395, 71628, 85393, 71216, 71651, 85208, 71163, 71408, 71499, 71541, 71668, 71771, 71602, 71260, 71276, 71324, 71726, 71068, 71300, 71482, 71339, 71452, 71464, 71465, 71468, 71470, 71471, 71472, 71473, 71479, 71480, 71492, 71497, 71506, 71509, 71511, 71514, 71516, 71517, 71519, 71520, 71548, 71553, 71554, 71559, 71560, 71567, 71588, 71596, 71601, 71605, 71609, 71614, 71621, 71622, 71624, 71626, 71629, 71631, 71633, 71637, 71642, 71653, 71654, 71685, 71687, 71690, 71692, 71695, 71698, 71699, 71702, 71707, 71708, 71709, 71713, 71714, 71716, 71734, 71738, 71744, 71755, 71765, 71775, 71779, 71783, 71784, 71786, 71788, 71804, 71807, 71814, 71818, 71819, 71820, 71821, 71834, 71839, 71840, 71856, 71861, 71868, 71872, 71875, 71876, 71877, 71894, 71898, 71908, 71913, 71917, 71928, 71930, 71935, 71944, 71946, 71951, 71952, 71957, 71958, 71973, 71987, 71988, 85010, 85024, 85026, 85028, 85037, 85042, 85048, 85049, 85050, 85061, 85065, 85073, 85075, 85079, 85096, 85098, 85099, 85105, 85111, 85112, 85127, 85141, 85152, 85153, 85160, 85162, 85168, 85169, 85170, 85171, 85172, 85174, 85177, 85178, 85184, 85198, 85200, 85204, 85218, 85220, 85226, 85230, 85242, 85243, 85247, 85249, 85251, 85259, 85263, 85268, 85269, 85270, 85272, 85280, 85282, 85283, 85284, 85285, 85288, 85290, 85291, 85294, 85300, 85303, 85305, 85309, 85310, 85311, 85313, 85314, 85323, 85325, 85329, 85332, 85333, 85334, 85335, 85336, 85339, 85344, 85345, 85346, 85349, 85350, 85351, 85353, 85354, 85355, 85356, 85357, 85358, 85359, 85360, 85361, 85362, 85364, 85369, 85370, 85371, 85373, 85374, 85375, 85376, 85380, 85382, 85383, 85384, 85385, 85386, 85387, 85389, 85390, 85392, 85397, 85398, 85399, 85401, 85402, 85403, 85406, 85407, 85408, 85412, 85413, 85415, 85416, 85417, 85418, 85419, 85420, 85422, 85425, 85426, 85427, 85429, 85430, 85431, 85432, 85433, 85434, 85439, 85440, 85442, 85447, 85448, 85449, 85453, 85454, 85455, 85456, 85457, 85458, 85460, 85461, 85462, 85463, 85466, 85467, 85468, 85469, 85470, 85471, 85476, 85478, 85479, 85480, 85481, 85483, 85484, 85485, 85487, 85488, 85490, 85491, 85494, 85496, 85497, 85498, 85499, 85501, 85504, 85506, 85507, 85509, 85510, 85515, 85517, 85518, 85519, 85522, 85524, 85525, 85526, 85527, 85528, 85531, 85532, 85533, 85535, 71372, 71649, 71581, 71582, 71748, 85143, 71405, 71373, 85265, 71047, 71662, 71678, 71891, 85189, 71267, 71353, 71402, 71457, 85450, 85451, 71474, 71338, 71418, 71924, 71991, 85202, 85306, 71437, 71003, 71020, 71023, 71173, 71192, 71283, 71288, 71298, 71315, 71337, 71359, 71363, 71370, 71396, 71400, 71440, 71501, 71576, 71590, 71603, 71751, 71791, 71838, 71874, 85025, 85161, 85253, 85301, 85319, 85342, 85391, 71346, 71362, 71910, 71983, 85063, 85183, 85205, 85206, 85216, 85341, 71334, 71409, 71476, 85023, 71061, 71106, 71162, 71165, 71181, 71280, 71349, 71351, 71357, 71410, 71428, 71460, 71477, 71512, 71518, 71643, 71677, 71691, 71717, 71743, 71750, 71762, 71763, 71842, 71854, 71900, 71966, 71967, 85122, 85140, 85147, 85149, 85190, 85203, 85210, 85224, 85318, 71367, 71461, 71545, 85241, 85302, 85348, 85372, 85459, 71423, 71177, 71326, 71424, 71681, 71758, 71863, 71892, 85057, 85245, 85246, 85250, 85286, 71001, 71002, 71004, 71007, 71012, 71013, 71014, 71035, 71037, 71039, 71056, 71070, 71093, 71095, 71154, 71155, 71174, 71175, 71183, 71211, 71228, 71268, 71269, 71282, 71341, 71347, 71361, 71401, 71411, 71413, 71416, 71425, 71429, 71450, 71463, 71489, 71498, 71527, 71571, 71587, 71589, 71592, 71635, 71641, 71652, 71655, 71659, 71670, 71676, 71682, 71686, 71694, 71760, 71766, 71767, 71772, 71778, 71801, 71802, 71825, 71844, 71851, 71864, 71869, 71878, 71879, 71880, 71881, 71882, 71897, 71972, 71992, 85022, 85038, 85064, 85069, 85074, 85076, 85083, 85121, 85124, 85217, 85377, 85378, 85381, 85396, 85400, 71086, 71343, 71671, 71679, 85428, 71107, 85166, 71058, 71078, 71176, 71263, 71299, 71307, 71321, 71387, 71575, 71625, 71640, 71799, 71852, 85181, 85187, 85312, 85330, 85365, 71172, 71195, 71790, 71948, 71996, 85004, 85136, 85223, 85317, 85109, 71956, 85232, 85304, 85021, 71159, 71364, 71380, 71563, 71953, 71170, 71296, 71781, 85213, 71097, 71722, 71335, 71919, 85148, 85367, 71302, 85366, 71150, 71188, 71225, 71360, 71634, 71665, 71884, 85009, 71510, 71746, 85018, 71648, 85236, 85260, 85368, 71220, 71227, 71272, 71350, 71451, 71522, 71700, 85012, 85054, 85316, 85388, 85414, 71077, 71204, 71365, 71398, 85091, 71478, 71618, 71826, 71669, 71764, 71833, 71867, 71270, 71051, 71231, 71604, 71650, 71689, 71823, 71895, 85059, 85321, 85340, 71600, 71848, 71305, 71445, 71566, 71018, 71040, 71072, 71189, 71197, 71198, 71224, 71332, 71384, 71434, 71442, 71448, 71486, 71496, 71597, 71623, 71644, 71645, 71703, 71706, 71737, 71752, 71871, 85081, 85114, 85142, 71314, 71583, 71808, 71916, 71291, 71304, 71368, 71371, 71711, 71756, 71822, 71860, 71911, 71931, 71936, 85123, 85125, 85185, 85193, 71333, 71377, 71386, 71524, 71785, 71789, 71986, 85019, 85209, 85295, 85322, 71352, 71426, 71977, 85020, 71215, 71285, 71287, 71308, 71318, 71354, 71459, 71490, 71534, 85101, 71010, 71016, 71022, 71029, 71045, 71062, 71064, 71065, 71071, 71073, 71153, 71187, 71190, 71194, 71200, 71203, 71213, 71275, 71277, 71317, 71319, 71331, 71336, 71369, 71376, 71379, 71382, 71388, 71397, 71399, 71407, 71415, 71444, 71456, 71483, 71495, 71528, 71529, 71569, 71570, 71584, 71599, 71667, 71675, 71680, 71683, 71721, 71732, 71735, 71796, 71805, 71810, 71827, 71829, 71858, 71893, 71914, 71982, 85067, 85094, 85154, 85221, 85275, 85278, 85436, 71436, 85222, 71544; 2. Model Numbers (REF): 781377(3.0T); UDI-DI: 884838009813; Serial Numbers: 42175, 42190, 42221, 42231, 42283, 42291, 42339, 42439, 42466, 42186, 42147, 42171, 42183, 42206, 42213, 42448, 42243, 42251, 42280, 42326, 42343, 42362, 42367, 42380, 42398, 42436, 42444, 42445, 42446, 42452, 42453, 42454, 42458, 42459, 42463, 42469, 42490, 42491, 42492, 42493, 42494, 42495, 42496, 42499, 42500, 42502, 42504, 42505, 42506, 42507, 42508, 42510, 42512, 42520, 42522, 42525, 42528, 42530, 42531, 42545, 42546, 42547, 42548, 42549, 42552, 42553, 42554, 42555, 42556, 42557, 42558, 42560, 42561, 42565, 42570, 42042, 42239, 42178, 42041, 42092, 42005, 42013, 42015, 42021, 42027, 42028, 42061, 42073, 42081, 42082, 42090, 42097, 42107, 42130, 42138, 42141, 42143, 42145, 42216, 42279, 42292, 42315, 42044, 42089, 42232, 42272, 42026, 42047, 42110, 42146, 42191, 42192, 42285, 42364, 42407, 42426, 42136, 42137, 42199, 42275, 42014, 42056, 42074, 42093, 42095, 42103, 42112, 42115, 42121, 42128, 42133, 42161, 42162, 42179, 42203, 42205, 42222, 42233, 42237, 42245, 42249, 42252, 42253, 42257, 42260, 42261, 42262, 42263, 42278, 42282, 42289, 42300, 42309, 42314, 42331, 42333, 42337, 42345, 42347, 42349, 42361, 42378, 42383, 42392, 42412, 42420, 42421, 42422, 42432, 42442, 42428, 42087, 42120, 42170, 42201, 42267, 42401, 42449, 42294, 42019, 42390, 42451, 42135, 42209, 42008, 42236, 42353, 42355, 42455, 42256, 42043, 42438, 42265, 42321, 42018, 42012, 42065, 42079, 42132, 42134, 42176, 42303, 42338, 42399, 42419, 42264, 42131, 42204, 42055, 42220, 42358, 42413, 42001, 42006, 42034, 42036, 42038, 42040, 42045, 42050, 42052, 42053, 42067, 42068, 42076, 42083, 42096, 42099, 42100, 42101, 42102, 42111, 42116, 42117, 42119, 42123, 42150, 42152, 42169, 42177, 42180, 42185, 42214, 42229, 42240, 42241, 42242, 42247, 42266, 42274, 42286, 42298, 42307, 42328, 42334, 42356, 42365, 42368, 42370, 42389, 42400, 42429, 42077, 42066; 3. Model Numbers (REF): 782103(3.0T); UDI-DI: 884838098299; Serial Numbers: 85724, 85667, 85622, 85625, 85626, 85628, 85629, 85630, 85631, 85633, 85636, 85637, 85638, 85641, 85642, 85650, 85656, 85657, 85658, 85659, 85660, 85662, 85692, 85710, 85715, 85721, 85722, 85725, 85727, 85729, 85735, 85738, 85739, 85740, 85743, 85745, 85746, 85747, 85748, 85749, 85756, 85696, 85620, 85608, 85614, 85755, 85672, 85673, 85674, 85720, 85730, 85732, 85762, 85693, 85619, 85718, 85600, 85607, 85616, 85617, 85707, 85613, 85611, 85612, 85615, 85703, 85719, 85666, 85664, 85700, 85643, 85644, 85761; 4. Model Numbers (REF): 781271(3.0T CX); UDI-DI: 884838068452; Serial Numbers: 78121, 78150, 78157, 78096, 78012, 78074, 78154, 78161, 78170, 78171, 78172, 78173, 78182, 78183, 78189, 78190, 78196, 78198, 78205, 78210, 78212, 78213, 78216, 78218, 78221, 78225, 78240, 78242, 78243, 78244, 78250, 78251, 78252, 78253, 78256, 78257, 78262, 78263, 78265, 78266, 78267, 78268, 78269, 78270, 78271, 78272, 78273, 78279, 78280, 78281, 78282, 78283, 78284, 78288, 78289, 78291, 78292, 78293, 78294, 78295, 78296, 78301, 78305, 78306, 78307, 78308, 78309, 78310, 78312, 78313, 78314, 78316, 78317, 78319, 78320, 78321, 78322, 78323, 78327, 78328, 78329, 78330, 78332, 78333, 78334, 78335, 78338, 78339, 78340, 78341, 78342, 78343, 78345, 78346, 78347, 78352, 78353, 78354, 78356, 78357, 78358, 78359, 78360, 78361, 78362, 78363, 78364, 78366, 78368, 78370, 78374, 78375, 78376, 78377, 78386, 78078, 78224, 78098, 78003, 78065, 78070, 78076, 78081, 78087, 78097, 78099, 78101, 78104, 78107, 78126, 78149, 78151, 78181, 78206, 78219, 78264, 78064, 78106, 78187, 78000, 78007, 78010, 78015, 78018, 78019, 78021, 78023, 78029, 78031, 78032, 78038, 78039, 78043, 78048, 78049, 78051, 78062, 78068, 78072, 78082, 78083, 78084, 78088, 78089, 78091, 78095, 78100, 78109, 78111, 78117, 78127, 78129, 78132, 78133, 78139, 78140, 78155, 78203, 78207, 78214, 78222, 78223, 78011, 78013, 78014, 78034, 78044, 78046, 78047, 78058, 78060, 78066, 78071, 78073, 78075, 78077, 78086, 78092, 78102, 78110, 78118, 78120, 78128, 78135, 78137, 78138, 78141, 78142, 78158, 78162, 78164, 78180, 78188, 78193, 78194, 78209, 78215, 78227, 78232, 78234, 78247, 78254, 78255, 78261, 78277, 78290, 78297, 78298, 78299, 78326, 78337, 78004, 78030, 78059, 78156, 78249, 78026, 78022; 5. Model Numbers (REF): 782105(3.0T CX); UDI-DI: 884838098312; Serial Numbers: 78516, 78517, 78518, 78519, 78521, 78522, 78523, 78524, 78525, 78526, 78527, 78528, 78529, 78530, 78531, 78536, 78537, 78539, 78545, 78546, 78547, 78548, 78549, 78550, 78551, 78553, 78554, 78555, 78556, 78557, 78558, 78559, 78560, 78561, 78562, 78564, 78565, 78567, 78570, 78571, 78573, 78574, 78500, 78501, 78503, 78504, 78505, 78507, 78508, 78512, 78513, 78532, 78535, 78538, 78540, 78541, 78542, 78543, 78544, 78552, 78566, 78568;
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia;
Firm notified the public via
Letter
FDA event ID
99769
Recall initiated
August 21, 2026
FDA classified
September 18, 2026
FDA report date
September 30, 2026

Other medical device recalls from around the same time

Verify with the official sources:

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

Report a data error on this page