Lower risk Medical device recall · FDA · Published December 2, 2020
Boston Scientific EMBLEM S-ICD Model A209 Recall: Electrical Overstress Risk
Boston Scientific recalls EMBLEM S-ICD Model A209 devices with specific serial numbers due to electrical overstress potentially causing device malfunction. Affected units include 100+ serial numbers listed. Consumers should check their device.
Lower-risk recall
Electrical overstress may lead to device malfunction.
Contact the company
Recalling firmBoston Scientific Corporation4100 Hamline Ave N Bldg 3 · Saint Paul, MN 55112-5700
What happened, in plain English
Boston Scientific is recalling EMBLEM S-ICD Model A209 devices with specific serial numbers because electrical overstress could cause device malfunction. This recall affects approximately 100 devices. If you own one of these models, you should check your serial number against the list provided. Read more at govinfonow.com/recall/63728-boston-scientific-emblem-s-icd-model-a209-recall-electrical-overstress.
Source Summary by GovInfoNow · govinfonow.com/recall/63728-boston-scientific-emblem-s-icd-model-a209-recall-electrical-overstress · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0950-2021
Cite this page
“Boston Scientific EMBLEM S-ICD Model A209 Recall: Electrical Overstress Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63728-boston-scientific-emblem-s-icd-model-a209-recall-electrical-overstress. Based on FDA recall #Z-0950-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0950-2021%22&limit=1).
Why it’s dangerous
Electrical overstress in the device could lead to malfunction, which might cause the device to not function properly. This is a potential issue but does not indicate immediate danger to health or safety.
Who’s affected
Individuals who own the EMBLEM S-ICD Model A209 device with the listed serial numbers are affected. Patients with this device are most at risk due to potential malfunction.
How to tell if you have this one
Check your EMBLEM S-ICD Model A209 device's serial number against the list of 100+ serial numbers provided in the recall notice. The device is a medical implant.
- Brand
Boston Scientific- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0950-2021 | EMBLEM S-ICD Model A209; Serial numbers: 104254, 104259, 104277, 104292, 104299, 104304, 104305, 104307, 104310, 104322, 104331, 104339, 104340, 104341, 104348, 104349, 104351, 104355, 104356, 104357, 104365, 104430, 104440, 104562, 104736, 104778, 104812, 104813, 104816, 104879, 104892, 104905, 104906, 104914, 104915, 104920, 104926, 104931, 104934, 104935, 104938, 104939, 104943, 104946, 104947, 104964, 104967, 104970, 104972, 104988, 104989, 104991, 104995, 104999, 105014, 105016, 105018, 105019, 105020, 105021, 105022, 105023, 105025, 105027, 105039, 105040, 105041, 105046, 105048, 105053, 105054, 105056, 105059, 105063, 105064, 105066, 105070, 105073, 105074, 105078, 105080, 105086, 105089, 105116, 105117, 105130, 105131, 105132, 105143, 105162, 105163, 105164, 105167, 105169, 105179, 105188, 105192, 105200, 105201, 105217, 105218, 105236, 105238, 105239, 105245, 105248, 105272, 105276, 105304, 105309, 105310, 105312, 105319, 105321, 105325, 105328, 105329, 105330, 105332, 105347, 105348, 105350, 105351, 105353, 105354, 105362, 105364, 105366, 105376, 105379, 105380, 105384, 105385, 105386, 105388, 105391, 105393, 105398, 105402, 105403, 105404, 105406, 105412, 105414, 105423, 105428, 105430, 105434, 105436, 105443, 105444, 105445, 105447, 105453, 105455, 105472, 105480, 105511, 105515, 105521, 105528, 105531, 105534, 105549, 105567, 105575, 105578, 105590, 105591, 105610, 105617, 105626, 105638, 105644, 105648, 105659, 105663, 105669, 105675, 105680, 105686, 105688, 105714, 105756, 105798, 105806, 105823, 105825, 105829, 105840, 105845, 105851, 105861, 105862, 105869, 105870, 105878, 105880, 105881, 105891, 105893, 105897, 105916, 105928, 105946, 105952, 105953, 105967, 105992, 105998, 106026, 106030, 106040, 106048, 106056, 106057, 106058, 106062, 106067, 106069, 106079, 106092, 106104, 106112, 106119, 106121, 106129, 106138, 106151, 106160, 106161, 106169, 106198, 106200, 106202, 106216, 106234, 106246, 106249, 106263, 106271, 106320, 106327, 106331, 106334, 106343, 106348, 106349, 106356, 106366, 106388, 106394, 106396, 106414, 106416, 106417, 106418, 106422, 106424, 106451, 106453, 106457, 106458, 106460, 106462, 106464, 106474, 106478, 106481, 106485, 106498, 106500, 106626, 106639, 106643, 106677, 106685, 106689, 106769, 106772, 106773, 106776, 106835, 106882, 106886, 106905, 106923, 106955, 107040, 107057, 107067, 107082, 107099, 107131, 107157, 107158, 107161, 107162, 107163, 107164, 107166, 107167, 107168, 107169, 107172, 107174, 107182, 107208, 107226, 107227, 107230, 107231, 107232, 107233, 107234, 107241, 107242, 107243, 107244, 107245, 107246, 107247, 107251, 107252, 107253, 107254, 107262, 107268, 107276, 107279, 107288, 107290, 107291, 107295, 107296, 107298, 107320, 107328, 107336, 107339, 107345, 107398, 107401, 107407, 107415, 107417, 107456, 107489, 107490, 107492, 107493, 107505, 107518, 107526, 107527, 107532, 107534, 107540, 107543, 107544, 107559, 107561, 107563, 107564, 107565, 107572, 107583, 107586, 107588, 107590, 107593, 107594, 107601, 107604, 107612, 107619, 107621, 107623, 107625, 107626, 107631, 107632, 107653, 107654, 107657, 107665, 107668, 107673, 107676, 107679, 107711, 107716, 107738, 107744, 107745, 107754, 107757, 107763, 107765, 107771, 107774, 107775, 107784, 107785, 107792, 107793, 107795, 107796, 107798, 107803, 107804, 107813, 107814, 107815, 107832, 107833, 107836, 107840, 107842, 107845, 107848, 107861, 107870, 107872, 107873, 107876, 107881, 107885, 107889, 107895, 107906, 107910, 107917, 107920, 107928, 107936, 107946, 107954, 107955, 107977, 107978, 107995, 107997, 108000, 108001, 108005, 108006, 108009, 108011, 108017, 108019, 108021, 108050, 108057, 108077, 108088, 108094, 108106, 108111, 108112, 108113, 108126, 108131, 108244, 108256, 108308, 108323, 108324, 108325, 108347, 108377, 108379, 108391, 108392, 108398, 108400, 108411, 108415, 108419, 108420, 108425, 108431, 108432, 108436, 108443, 108448, 108449, 108450, 108455, 108456, 108457, 108461, 108462, 108497, 108498, 108503, 108509, 108510, 108512, 108513, 108515, 108518, 108529, 108531, 108532, 108560, 108577, 108578, 108597, 108603, 108617, 108621, 108629, 108642, 108651, 108657, 108658, 108726, 108727, 108728, 108729, 108730, 108731, 108735, 108736, 108826, 108829, 108833, 108841, 108843, 108844, 108849, 108851, 108852, 108857, 108862, 108865, 108866, 108867, 108873, 108876, 108877, 108883, 108889, 108890, 108892, 108896, 108899, 108900, 108901, 108905, 108924, 108926, 108934, 108974, 108996, 109005, 109006, 109011, 109039, 109049, 109082, 109155, 109400, 109422, 109438, 109513, 109516, 109528, 109556, 109567, 109570, 109622, 109678, 109706, 109742, 109743, 109773, 109846, 109853, 109924, 109933, 109939, 109961, 109992, 109996, 110023, 110033, 110041, 110046, 110047, 110060, 110096, 110418, 110431, 110433, 110435, 110436, 110438, 110440, 110463, 110467, 110478, 110481, 110484, 110489, 110491, 110493, 110508, 110524, 110529, 110530, 110576, 110587, 110588, 110591, 110598, 110599, 110601, 110604, 110605, 110607, 110616, 110620, 110661, 110670, 110683, 110695, 110696, 110741, 110745, 110753, 110757, 110758, 110824, 110827, 110844, 110870, 110872, 110874, 110896, 110920, 110925, 110926, 110931, 110932, 110934, 110943, 110949, 110950, 110952, 110954, 110955, 110965, 110978, 110990, 110999, 111001, 111002, 111009, 111014, 111052, 111066, 111490, 111585, 111613, 111660, 111686, 111688, 111690, 111696, 111702, 111705, 111715, 111725, 111733, 111780, 111808, 111814, 111815, 111931, 111932, 111933, 111935, 111942, 111946, 111982, 112018, 112080, 112084, 112092, 112097, 112113, 112119, 112124, 112125, 112126, 112136, 112242, 112252, 112257, 112261, 112264, 112290, 112333, 112338, 112378, 112385, 112386, 112390, 112398, 112434, 112435, 112446, 112460, 112474, 112484, 112490, 112562, 112580, 112611, 112630, 112688, 112697, 112746, 112781, 112787, 112809, 112812, 112813, 112818, 112825, 112827, 112886, 112887, 112894, 112898, 112899, 112903, 112904, 112929, 112938, 112952, 112955, 112961, 112965, 112973, 112977, 113027, 113048, 113072, 113096, 113098, 113102, 113106, 113123, 113127, 113131, 113132, 113136, 113140, 113141, 113146, 113147, 113155, 113156, 113157, 113176, 113180, 113182, 113187, 113189, 113197, 113208, 113213, 113219, 113228, 113229, 113230, 113234, 113236, 113239, 113243, 113247, 113248, 113257, 113272, 113273, 113292, 113397, 113404, 113411, 113419, 113421, 113422, 113427, 113438, 113446, 113454, 113458, 113464, 113471, 113474, 113480, 113494, 113500, 113504, 113507, 113540, 113638, 113640, 113644, 113647, 113648, 113649, 113658, 113681, 113687, 113692, 113699, 113715, 113718, 113721, 113732, 113746, 113766, 113777, 113798, 113801, 113806, 113808, 113809, 113810, 113811, 113821, 113823, 113825, 113827, 113829, 113833, 113834, 113837, 113838, 113843, 113848, 113850, 113851, 113867, 113921, 113942, 113946, 113949, 113954, 113958, 113968, 114046, 114086, 114103, 114124, 114180, 114205, 114283, 114457, 114462, 114464, 114532, 114540, 114546, 114548, 114556, 114560, 114562, 114563, 114576, 114582, 114590, 114597, 114625, 114630, 114636, 114641, 114643, 114688, 114704, 114733, 114735, 114881, 114961, 114990, 114992, 115051, 115176, 115185, 115194, 115209, 115217, 115230, 115234, 115329, 115361, 115418, 115436, 115449, 115517, 115528, 115531, 115541, 115551, 115557, 115561, 115567, 115569, 115570, 115605, 115615, 115633, 115645, 115651, 115655, 115670, 115678, 115687, 115720, 115735, 115738, 115739, 115744, 115745, 115749, 115752, 115763, 115767, 115768, 115770, 115772, 115811, 115813, 115814, 115826, 115829, 115836, 115839, 115906, 115908, 115910, 115946, 115947, 115965, 115989, 116021, 116024, 116026, 116027, 116040, 116080, 116110, 116280, 116324, 116327, 116328, 116373, 116375, 116380, 116401, 116418, 116636, 116639, 116978, 116985, 116989, 116997, 117211, 117214, 117216, 117220, 117234, 117273, 117275, 117277, 117296, 117372, 117395, 117406, 117430, 117481, 117587, 117604, 117673, 117685, 117696, 117701, 117711, 117714, 117717, 117718, 117762, 117763, 117764, 117773, 117774, 117780, 117785, 117786, 117787, 117788, 117789, 117791, 117793, 117807, 117808, 117825, 117827, 117828, 117830, 117833, 117839, 117841, 117843, 117851, 117852, 117853, 117857, 117861, 117865, 117866, 117868, 117876, 117880, 117882, 117888, 117890, 117895, 117896, 117898, 117899, 117901, 117904, 117905, 117908, 117910, 117912, 117915, 117916, 117921, 117922, 117925, 117927, 117933, 117935, 117950, 117951, 117967, 117998, 118003, 118004, 118005, 118018, 118033, 118057, 118060, 118061, 118063, 118156, 118307, 118414, 118423, 118430, 118433, 118437, 118440, 118460, 118466, 118469, 118484, 118486, 118494, 118495, 118496, 118515, 118524, 118533, 118534, 118538, 118542, 118550, 118553, 118557, 118560, 118561, 118570, 118572, 118574, 118577, 118578, 118579, 118584, 118598, 118601, 118607, 118608, 118612, 118622, 118641, 118642, 118644, 118646, 118654, 118675, 118689, 118694, 118698, 118731, 118735, 118736, 118748, 118750, 118765, 118769, 118775, 118776, 119201, 107308, 107521, 108352, 113285, 113415, 113646, 104252, 104255, 104897, 105118, 105124, 105314, 105390, 105437, 105471, 105495, 105551, 105553, 105834, 105976, 106055, 106229, 106252, 106435, 106472, 106502, 106565, 107181, 107299, 107723, 107890, 107940, 108012, 108027, 108048, 108429, 108435, 108437, 108526, 108553, 108581, 108588, 108640, 108663, 108666, 108668, 108669, 108743, 108842, 108853, 108870, 108871, 108874, 108875, 108906, 108930, 109041, 109053, 109091, 109592, 109679, 109767, 109786, 109940, 109968, 110062, 110091, 110264, 110448, 110482, 110549, 110614, 110930, 110964, 110995, 111405, 111418, 111890, 112133, 112241, 112247, 112312, 112387, 112393, 112409, 112463, 112465, 112487, 112558, 112820, 112919, 113101, 113149, 113405, 113423, 113460, 113468, 113470, 113482, 113561, 113564, 113704, 113714, 113901, 113934, 113973, 114209, 114285, 114307, 114312, 114474, 114561, 114607, 114731, 115221, 115722, 115956, 116017, 116993, 117236, 117376, 117424, 117468, 117588, 117603, 117609, 117614, 117621, 117643, 117670, 117772, 117782, 117811, 117823, 117826, 117837, 117838, 117840, 117845, 117862, 117878, 117900, 117942, 117952, 117959, 117973, 117975, 118001, 118050, 118067, 118088, 118420, 118492, 118559, 118573, 118677, 118680, 118688, 118800, 118996, 119016, 119019, 119045, 119065, 119142, 119174, 119176, 119177, 119180, 119181, 119194, 119381, 119600, 119644, 120021, 120023, 120027, 120040, 120059, 120065, 120066, 120069, 120167, 120178, 211720, 211735, 211747, 219298, 219428, 219445, 104156, 104263, 104269, 104272, 104273, 104284, 104303, 104308, 104317, 104320, 104321, 104330, 104332, 104338, 104360, 104364, 104756, 104817, 104984, 105049, 105057, 105085, 105190, 105209, 105210, 105211, 105213, 105215, 105216, 105220, 105223, 105225, 105230, 105233, 105234, 105237, 105240, 105247, 105257, 105258, 105265, 105302, 105311, 105313, 105378, 105381, 105383, 105389, 105394, 105399, 105400, 105401, 105407, 105410, 105426, 105429, 105463, 105478, 105486, 105487, 105491, 105496, 105504, 105568, 105828, 105860, 105882, 105917, 105922, 105993, 106049, 106061, 106063, 106065, 106286, 106296, 106350, 106374, 106385, 106397, 106403, 106423, 106425, 106428, 106429, 106431, 106434, 106459, 106463, 106488, 106499, 106729, 106768, 106912, 107001, 107024, 107061, 107081, 107102, 107105, 107159, 107175, 107177, 107194, 107311, 107334, 107338, 107418, 107457, 107537, 107573, 107599, 107652, 107662, 107666, 107672, 107758, 107822, 107825, 107855, 107864, 107865, 107923, 107938, 107984, 107996, 108008, 108045, 108053, 108132, 108267, 108283, 108354, 108360, 108378, 108401, 108418, 108434, 108442, 108454, 108511, 108516, 108527, 108538, 108570, 108572, 108598, 108604, 108618, 108619, 108620, 108630, 108646, 108652, 108654, 108661, 108698, 108716, 108732, 108758, 108761, 108763, 108765, 108770, 108772, 108781, 108845, 108856, 108879, 108897, 108907, 108911, 108928, 108935, 108943, 108948, 108950, 108951, 108973, 108983, 108991, 108994, 108995, 108997, 109010, 109013, 109047, 109048, 109067, 109068, 109070, 109072, 109080, 109083, 109084, 109478, 109517, 109609, 109623, 109624, 109625, 109676, 109700, 109752, 109795, 109910, 109912, 109913, 109935, 110006, 110032, 110105, 110106, 110108, 110117, 110261, 110412, 110417, 110419, 110420, 110422, 110423, 110426, 110428, 110430, 110432, 110434, 110439, 110453, 110466, 110469, 110470, 110473, 110505, 110509, 110523, 110546, 110577, 110578, 110595, 110606, 110609, 110610, 110611, 110615, 110619, 110669, 110671, 110967, 110979, 110981, 111081, 111399, 111415, 111450, 111509, 111532, 111652, 111657, 111659, 111701, 111810, 111812, 111817, 111928, 111929, 111930, 111934, 111969, 112022, 112078, 112079, 112117, 112118, 112260, 112324, 112369, 112371, 112373, 112374, 112377, 112399, 112402, 112418, 112422, 112423, 112425, 112426, 112429, 112431, 112432, 112433, 112436, 112437, 112438, 112439, 112441, 112442, 112444, 112445, 112458, 112480, 112555, 112560, 112588, 112601, 112808, 112816, 112840, 112883, 112888, 112889, 112900, 112901, 112909, 112966, 112976, 112982, 113015, 113105, 113117, 113150, 113158, 113179, 113183, 113196, 113215, 113223, 113232, 113238, 113244, 113246, 113251, 113290, 113396, 113416, 113420, 113466, 113476, 113477, 113479, 113490, 113509, 113519, 113521, 113524, 113551, 113554, 113572, 113574, 113600, 113650, 113659, 113660, 113666, 113668, 113675, 113698, 113706, 113771, 113772, 113781, 113796, 113799, 113807, 113814, 113830, 113836, 113839, 113841, 113856, 113857, 113858, 113886, 113907, 113919, 113936, 113972, 113975, 114010, 114040, 114087, 114112, 114178, 114296, 114451, 114456, 114466, 114538, 114543, 114557, 114565, 114571, 114589, 114600, 114603, 114700, 114919, 115000, 115552, 115565, 115571, 115572, 115582, 115588, 115659, 115665, 115672, 115726, 115754, 115769, 115798, 115823, 115831, 115934, 115945, 115961, 115980, 115981, 116022, 116030, 116062, 116066, 116082, 116083, 116111, 116638, 116979, 116983, 116987, 117076, 117256, 117269, 117404, 117420, 117432, 117441, 117450, 117470, 117487, 117494, 117566, 117572, 117577, 117579, 117581, 117582, 117589, 117600, 117602, 117628, 117629, 117662, 117667, 117672, 117686, 117691, 117698, 117713, 117752, 117753, 117771, 117777, 117800, 117815, 117829, 117832, 117834, 117835, 117836, 117856, 117858, 117883, 117889, 117902, 117909, 117923, 117924, 117926, 117931, 117932, 117937, 117944, 117953, 117964, 117985, 117991, 117992, 118002, 118016, 118039, 118041, 118048, 118056, 118071, 118075, 118076, 118082, 118092, 118144, 118187, 118301, 118367, 118373, 118416, 118465, 118493, 118521, 118532, 118539, 118543, 118545, 118547, 118548, 118554, 118571, 118602, 118605, 118623, 118624, 118643, 118645, 118652, 118670, 118674, 118681, 118690, 118696, 118699, 118744, 118767, 118772, 118777, 118985, 119068, 119093, 119130, 119150, 119162, 119175, 119178, 119182, 119195, 119196, 119197, 119199, 119200, 119202, 119204, 119206, 119208, 119324, 119602, 119640, 119641, 119643, 119646, 119659, 119666, 119670, 119992, 120009, 120014, 120018, 120028, 120031, 120032, 120039, 120043, 120062, 120067, 120068, 120071, 120080, 120096, 120101, 120124, 120159, 120168, 120172, 120173, 120180, 120183, 121346, 121350, 121356, 121362, 121363, 121480, 201823, 211623, 211658, 211669, 211675, 211677, 211681, 211685, 211700, 211717, 211732, 211754, 211810, 212757, 212791, 213052, 214274, 214286, 214289, 214530, 214864, 214882, 214904, 215091, 215104, 215111, 215179, 215205, 215207, 215213, 215222, 215227, 215240, 215256, 215257, 215658, 218179, 218243, 218260, 218286, 218291, 218298, 218321, 218326, 218720, 219141, 219272, 219359, 219403, 219412, 219420, 219431, 219444 | 1953 units |
| Z-0951-2021 | EMBLEM MRI S-ICD Model A219; Serial numbers: 100641, 200266, 200291, 200317, 200347, 200348, 200359, 200368, 200369, 200375, 200378, 200431, 200479, 200481, 200631, 200762, 200786, 200787, 200818, 200821, 200822, 200838, 200848, 200854, 200874, 200888, 200889, 200896, 200899, 200905, 200910, 200914, 200919, 200925, 200927, 200965, 200966, 200979, 200986, 200990, 200991, 200992, 200995, 200996, 200997, 201012, 201016, 201021, 201024, 201031, 201036, 201044, 201050, 201103, 201131, 201133, 201135, 201137, 201157, 201172, 201180, 201182, 201188, 201193, 201264, 201333, 201338, 201353, 201424, 201434, 201460, 201464, 201476, 201491, 201498, 201501, 201510, 201512, 201513, 201514, 201515, 201516, 201517, 201521, 201525, 201544, 201545, 201548, 201551, 201555, 201556, 201557, 201558, 201571, 201600, 201651, 201655, 201662, 201709, 201711, 201713, 201714, 201727, 201747, 201748, 202039, 202042, 202062, 202063, 202065, 202083, 202094, 202833, 203238, 203246, 203249, 203285, 203293, 203301, 203302, 203307, 203311, 203330, 203339, 203341, 203346, 203348, 203362, 203380, 203394, 203397, 203408, 203410, 203413, 203414, 203430, 203438, 203443, 203463, 203480, 203484, 203486, 203492, 203495, 203496, 203498, 203499, 203500, 203502, 203503, 203504, 203505, 203525, 203539, 203541, 203544, 203555, 203557, 203589, 203598, 203611, 204071, 204085, 204111, 204116, 204135, 204145, 204175, 204191, 204206, 204210, 204212, 204236, 204243, 204250, 204255, 204449, 205608, 205613, 205618, 205619, 205620, 205627, 205647, 205684, 205686, 205712, 205727, 205730, 205739, 205760, 205769, 205776, 205781, 205886, 205891, 205904, 205908, 205928, 205931, 205943, 205956, 205965, 205969, 205981, 205985, 205988, 206021, 206025, 206036, 206045, 206102, 206110, 206332, 206333, 206338, 206373, 206403, 206408, 206413, 206417, 206426, 206429, 206472, 210777, 210847, 210848, 210914, 211697, 211722, 211734, 211737, 211756, 211786, 211804, 213096, 213333, 214197, 214213, 214254, 214269, 214271, 214272, 214275, 214287, 214292, 214295, 214300, 214305, 214348, 214349, 214350, 214370, 214393, 214405, 214430, 214435, 214448, 214451, 214455, 214460, 214568, 214578, 214582, 214583, 214603, 214611, 214635, 214636, 214641, 214653, 214796, 215109, 215112, 215113, 215130, 215140, 215158, 215159, 215162, 215164, 215191, 215202, 215237, 215349, 215357, 215358, 215378, 215389, 215394, 215395, 215396, 215399, 215401, 215409, 215410, 215434, 215449, 215457, 215458, 215460, 215466, 215469, 215476, 215478, 215482, 215484, 215487, 215489, 215496, 215498, 215503, 215512, 215514, 215521, 215534, 215543, 215546, 215557, 215559, 215561, 215571, 215575, 215581, 215583, 215586, 215590, 215591, 215596, 215598, 215599, 215600, 215601, 215604, 215618, 215622, 215631, 215645, 215646, 215649, 215659, 215661, 215662, 215664, 215665, 215670, 215672, 215674, 215675, 215684, 215685, 215686, 215687, 215688, 215690, 215691, 215700, 215704, 215706, 216554, 216560, 216573, 216664, 216694, 218089, 218094, 218113, 218253, 218255, 218265, 218290, 218331, 218409, 218432, 218458, 218464, 218526, 218705, 218710, 218718, 218721, 218740, 218741, 218749, 218765, 218797, 218806, 219237, 219254, 219255, 219263, 219287, 219364, 219402, 219411, 219415, 219422, 219423, 219425, 219430, 219432, 219434, 219437, 219440, 219446, 219450, 219453, 219473, 219476, 219478, 219480, 219481, 219485, 219486, 219535, 219682, 219746, 219784, 219824, 219831, 219836, 219843, 219846, 219854, 219855, 219856, 219857, 219860, 219868, 219869, 219870, 219879, 219886, 219891, 219930, 220006, 220026, 220033, 205771, 100294, 100297, 100303, 100500, 100565, 100724, 100737, 100749, 100761, 100865, 200289, 200315, 200338, 200885, 200926, 200993, 201023, 201042, 201496, 201497, 201508, 201547, 201621, 201633, 201649, 201654, 203444, 203526, 203616, 203660, 206038, 206047, 206381, 206382, 210752, 210758, 210845, 210917, 212845, 212850, 214616, 214679, 214890, 215099, 215153, 215450, 215452, 215492, 215502, 215506, 215579, 215640, 215692, 215705, 216545, 216547, 216564, 216623, 216639, 218000, 218092, 218212, 218257, 218719, 219238, 219439, 219667, 219789, 219851, 219874, 219922, 219980, 100295, 100296, 100298, 100299, 100300, 100301, 100302, 100450, 100473, 100477, 100479, 100491, 100508, 100514, 100518, 100520, 100555, 100569, 100573, 100615, 100626, 100673, 100695, 100759, 100760, 100766, 100869, 100880, 200282, 200295, 200305, 200316, 200327, 200332, 200764, 200780, 200789, 200797, 200809, 200820, 200860, 200863, 200870, 200886, 200900, 200912, 200967, 200985, 200999, 201038, 201053, 201121, 201412, 201489, 201495, 201499, 201500, 201503, 201511, 201518, 201522, 201523, 201530, 201543, 201546, 201549, 201559, 201566, 201574, 201576, 201588, 201630, 201650, 201656, 201669, 201682, 201694, 201710, 201719, 201728, 201729, 201803, 201969, 202090, 202435, 203334, 203403, 203538, 203550, 203562, 203570, 203571, 203581, 203588, 203594, 203605, 203639, 203640, 203644, 203662, 205379, 205660, 205862, 205890, 205893, 205899, 205929, 205935, 205937, 205982, 205996, 206007, 206042, 206043, 206052, 206053, 206070, 206092, 206100, 206340, 206371, 206377, 206378, 206384, 206385, 206396, 206401, 206404, 206405, 206407, 206409, 206420, 206422, 206439, 206441, 210731, 210732, 210763, 210830, 210839, 210840, 210842, 210849, 210850, 210854, 210915, 211752, 211780, 212033, 212093, 212100, 212114, 212715, 212849, 212870, 213095, 214273, 214366, 214396, 214566, 214570, 214579, 214581, 214599, 214609, 214612, 214626, 214627, 214630, 214631, 214632, 214633, 214634, 214639, 214640, 214643, 214644, 214646, 214650, 214655, 214685, 214792, 214794, 214797, 214798, 214830, 214862, 214867, 214868, 214871, 214872, 214873, 214874, 214875, 214876, 214877, 214880, 214881, 214885, 214887, 214893, 214895, 214896, 214897, 214906, 214907, 214908, 215093, 215141, 215146, 215152, 215175, 215178, 215192, 215206, 215241, 215261, 215317, 215365, 215369, 215391, 215441, 215465, 215467, 215470, 215480, 215481, 215483, 215488, 215490, 215491, 215493, 215495, 215497, 215499, 215500, 215504, 215513, 215515, 215524, 215540, 215545, 215549, 215558, 215569, 215576, 215578, 215580, 215584, 215585, 215593, 215595, 215607, 215629, 215638, 215650, 215653, 215657, 215660, 215666, 215667, 215669, 215671, 215676, 215677, 215681, 215682, 215689, 215697, 215698, 215703, 216544, 216549, 216552, 216559, 216565, 216566, 216570, 216617, 216620, 216621, 216622, 216636, 216637, 216641, 216642, 216687, 216689, 216853, 216859, 217923, 218076, 218081, 218084, 218087, 218107, 218110, 218119, 218120, 218130, 218134, 218135, 218140, 218148, 218174, 218213, 218214, 218251, 218262, 218307, 218370, 218403, 218408, 218415, 218428, 218429, 218435, 218441, 218444, 218477, 218706, 218782, 218792, 218809, 218960, 219236, 219288, 219323, 219334, 219404, 219408, 219409, 219413, 219427, 219429, 219443, 219459, 219474, 219475, 219518, 219675, 219736, 219796, 219802, 219808, 219820, 219821, 219839, 219842, 219844, 219845, 219849, 219861, 219863, 219864, 219866, 219871, 219876, 219882, 219923, 219952 | 872 units |
What to do — step by step
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Compare your device's serial number with the list of 100+ serial numbers provided in the recall notice.
How this recall unfolded
Recall timeline
FDA terminated this recall 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0950-2021 (December 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0950-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.