Recall archive / FDA device enforcement

Model Number L210 PROPONENT SR SL Pacemaker — FDA record Z-0088-2026

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 Aug 20, 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: Model Number L210 PROPONENT SR SL Pacemaker
Reason: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Classification: Class I
Recalling firm: Boston Scientific Corporation
Quantity: 41009 units
Agency-reported status: Ongoing
Source record identifier: Z-0088-2026

Open the official record

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	GTIN 00802526559082, Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045, 100046, 100047, 100049, 100054, 100057, 100061, 100066, 100068, 100071, 100072, 100073, 100074, 100083, 100085, 100093, 100097, 100100, 100103, 100104, 100109, 100112, 100121, 100122, 100124, 100125, 100135, 100136, 100138, 100140, 100147, 100153, 100156, 100162, 100163, 100165, 100166, 100168, 100170, 100171, 100181, 100197, 100205, 100214, 100222, 100235, 100237, 100268, 100270, 100271, 100272, 100273, 100280, 100281, 100288, 100295, 100302, 100309, 100324, 100328, 100337, 100339, 100354, 100359, 100360, 100363, 100369, 100372, 100377, 100384, 100386, 100387, 100391, 100400, 100403, 100404, 100410, 100411, 100413, 100415, 100421, 100423, 100431, 100432, 100434, 100435, 100438, 100439, 100440, 100443, 100460, 100473, 100488, 100491, 100492, 100496, 100502, 100504, 100510, 100526, 100534, 100535, 100536, 100539, 100546, 100547, 100548, 100549, 100551, 100552, 100556, 100561, 100567, 100581, 100584, 100585, 100587, 100588, 100592, 100593, 100598, 100599, 100602, 100604, 100605, 100606, 100610, 100613, 100619, 100623, 100629, 100630, 100634, 100639, 100640, 100644, 100647, 100650, 100653, 100661, 100663, 100666, 100669, 100674, 100681, 100682, 100686, 100688, 100692, 100694, 100696, 100698, 100702, 100708, 100713, 100719, 100720, 100722, 100724, 100728, 100730, 100737, 100742, 100743, 100749, 100750, 100754, 100756, 100757, 100762, 100764, 100765, 100768, 100773, 100774, 100778, 100783, 100785, 100791, 100794, 100797, 100815, 100823, 100826, 100827, 100828, 100831, 100832, 100839, 100840, 100841, 100847, 100848, 100853, 100854, 100855, 100856, 100860, 100861, 100864, 100885, 100886, 100887, 100899, 100902, 100905, 100906, 100907, 100908, 100917, 100920, 100921, 100928, 100929, 100934, 100937, 100938, 100940, 100941, 100943, 100944, 100949, 100951, 100956, 100957, 100960, 100962, 100969, 100975, 100978, 100983, 100985, 100986, 100987, 100988, 100989, 100991, 100994, 100997, 100999, 101007, 101013, 101014, 101015, 101016, 101018, 101020, 101025, 101033, 101037, 101039, 101047, 101048, 101049, 101053, 101054, 101058, 101060, 101061, 101065, 101069, 101074, 101075, 101076, 101077, 101078, 101079, 101082, 101084, 101087, 101088, 101089, 101094, 101100, 101101, 101102, 101104, 101107, 101108, 101110, 101115, 101117, 101121, 101122, 101124, 101129, 101131, 101136, 101137, 101138, 101139, 101140, 101141, 101143, 101144, 101145, 101146, 101149, 101158, 101159, 101160, 101164, 101167, 101169, 101172, 101174, 101177, 101179, 101181, 101182, 101190, 101192, 101194, 101196, 101205, 101206, 101207, 101217, 101223, 101229, 101230, 101234, 101236, 101238, 101239, 101240, 101243, 101244, 101247, 101250, 101253, 101256, 101257, 101258, 101259, 101262, 101265, 101268, 101274, 101283, 101287, 101291, 101292, 101306, 101309, 101311, 101318, 101321, 101322, 101325, 101336, 101337, 101343, 101348, 101357, 101358, 101386, 101392, 101396, 101397, 101398, 101402, 101406, 101408, 101418, 101419, 101420, 101421, 101423, 101424, 101426, 101427, 101433, 101434, 101447, 101448, 101453, 101454, 101457, 101460, 101472, 101486, 101489, 101491, 101492, 101493, 101498, 101499, 101500, 101501, 101502, 101504, 101506, 101507, 101509, 101516, 101518, 101519, 101521, 101531, 101532, 101534, 101535, 101536, 101537, 101539, 101540, 101543, 101550, 101554, 101556, 101563, 101571, 101573, 101575, 101576, 101586, 101589, 101591, 101598, 101608, 101609, 101610, 101612, 101620, 101630, 101641, 101655, 101700, 101704, 101711, 101742, 101828, 101835, 101857, 101862, 101868, 101877, 101878, 101886, 101889, 101902, 101924, 101932, 101961, 101969, 101971, 101979, 101986, 101989, 101995, 101999, 102001, 102004, 102012, 102016, 102018, 102019, 102021, 102025, 102027, 102030, 102033, 102036, 102038, 102040, 102041, 102044, 102055, 102058, 102061, 102062, 102063, 102065, 102069, 102072, 102073, 102074, 102075, 102078, 102091, 102093, 102094, 102096, 102098, 102100, 102101, 102102, 102103, 102106, 102107, 102111, 102112, 102114, 102117, 102120, 102123, 102124, 102125, 102126, 102127, 102128, 102130, 102131, 102132, 102135, 102149, 102159, 102167, 102171, 102172, 102174, 102187, 102190, 102191, 102192, 102194, 102200, 102232, 102238, 102239, 102242, 102244, 102267, 102302, 102308, 102309, 102313, 102317, 102319, 102323, 102325, 103468, 103473, 103475, 700013, 700014, 700025, 700035, 700096, 700103, 700104, 700208, 700221, 700225, 700226, 700237, 700243, 700245, 700247, 700249, 700257, 700264, 700279, 700283, 700292, 700299, 700316, 700321, 700326, 700328, 700337, 700340, 700341, 700342, 700344, 700376, 700402, 700413, 700416, 700419, 700436, 700437, 700438, 700447, 700450, 700451, 700452, 700458, 700460, 700467, 700468, 700469, 700470, 700471, 700474, 700475, 700476, 700479, 700481, 700484, 700486, 700488, 700490, 700491, 700492, 700502, 700504, 700506, 700508, 700510, 700517, 700518, 700519, 700524, 700531, 700537, 700538, 700540, 700541, 700545, 700551, 700552, 700555, 700559, 700566, 700569, 700571, 700575, 700579, 700586, 700594, 700596, 700599, 700603, 700604, 700605, 700619, 700660, 700661, 700685, 700712, 700721, 700725, 700733, 700737, 700745, 700754, 700762, 700763, 700764, 700766, 700767, 700770, 700771, 700784, 700788, 700790, 700791, 700794, 700798, 700801, 700805, 700807, 700811, 700814, 700816, 700818, 700819, 700826, 700827, 700829, 700832, 700833, 700834, 700842, 700857, 700859, 700860, 700863, 700868, 700869, 700871, 700873, 700879, 700895, 700897, 700898, 700901, 700906, 700907, 700908, 700910, 700911, 700912, 700913, 700917, 700926, 700931, 700933, 700935, 700941, 700991, 700994, 701001, 701021, 701022, 701025, 701026, 701027, 701031, 701036, 701038, 701043, 701045, 701048, 701051, 701053, 701057, 701058, 701061, 701062, 701065, 701071, 701072, 701076, 701080, 701082, 701086, 701088, 701091, 701093, 701098, 701100, 701111, 701115, 701121, 701136, 701137, 701138, 701144, 701156, 701160, 701175, 701186, 701188, 701191, 701194, 701208, 701209, 701215, 701223, 701234, 701235, 701255, 701262, 701267, 701278, 701282, 701285, 701288, 701289, 701290, 701298, 701300, 701303, 701304, 701315, 701317, 701320, 701334, 701343, 701350, 701354, 701355, 701364, 701365, 701373, 701374, 701375, 701385, 701404, 701409, 701411, 701413, 701420, 701422, 701430, 701432, 701437, 701439, 701446, 701447, 701449, 701450, 701455, 701460, 701462, 701475, 701484, 701485, 701486, 701490, 701495, 701498, 701504, 701509, 701518, 701520, 701521, 701522, 701523, 701532, 701536, 701539, 701543, 701550, 701555, 701556, 701561, 701562, 701567, 701577, 701578, 701580, 701587, 701592, 701596, 701602, 701604, 701605, 701606, 701608, 701610, 701613, 701625, 701626, 701627, 701628, 701632, 701634, 701636, 701641, 701646, 701648, 701654, 701655, 701665, 701670, 701673, 701674, 701679, 701681, 701683, 701687, 701689, 701690, 701694, 701699, 701701, 701702, 701703, 701705, 701706, 701708, 701710, 701713, 701717, 701720, 701728, 701731, 701733, 701737, 701741, 701743, 701752, 701753, 701755, 701756, 701763, 701772, 701774, 701777, 701779, 701781, 701784, 701787, 701789, 701791, 701792, 701793, 701804, 701806, 701813, 701814, 701822, 701825, 701827, 701828, 701829, 701831, 701834, 701835, 701836, 701839, 701840, 701841, 701848, 701850, 701852, 701862, 701867, 701868, 701872, 701876, 701877, 701881, 701884, 701890, 701891, 701895, 701896, 701897, 701903, 701906, 701911, 701919, 701921, 701926, 701928, 701929, 701932, 701945, 701946, 701948, 701949, 701951, 701953, 701957, 701961, 701962, 701971, 701972, 701978, 701979, 701985, 701986, 701994, 701996, 702002, 702003, 702008, 702010, 702011, 702014, 702020, 702022, 702025, 702026, 702028, 702032, 702047, 702054, 702055, 702057, 702067, 702078, 702081, 702088, 702093, 702095, 702097, 702102, 702106, 702109, 702111, 702113, 702114, 702118, 702124, 702125, 702130, 702131, 702145, 702146, 702148, 702156, 702157, 702160, 702162, 702165, 702169, 702170, 702174, 702175, 702184, 702185, 702189, 702196, 702201, 702204, 702208, 702212, 702213, 702214, 702215, 702217, 702219, 702229, 702240, 702243, 702248, 702252, 702265, 702266, 702267, 702274, 702276, 702277, 702283, 702286, 702292, 702295, 702297, 702298, 702299, 702300, 702301, 702322, 702336, 702338, 702339, 702349, 702351, 702353, 702361, 702363, 702368, 702372, 702378, 702399, 702400, 702403, 702405, 702407, 702410, 702411, 702412, 702413, 702415, 702419, 702420, 702422, 702427, 702428, 702430, 702433, 702438, 702440, 702441, 702443, 702447, 702448, 702449, 702450, 702451, 702453, 702457, 702459, 702460, 702461, 702462, 702463, 702468, 702469, 702470, 702473, 702478, 702481, 702485, 702491, 702492, 702493, 702496, 702497, 702500, 702504, 702506, 702507, 702508, 702509, 702511, 702512, 702515, 702517, 702518, 702524, 702525, 702527, 702529, 702531, 702532, 702533, 702540, 702545, 702547, 702550, 702551, 702553, 702554, 702555, 702556, 702558, 702559, 702561, 702563, 702567, 702571, 702578, 702581, 702582, 702585, 702586, 702590, 702596, 702598, 702599, 702600, 702601, 702602, 702604, 702606, 702611, 702613, 702614, 702617, 702620, 702624, 702626, 702627, 702628, 702630, 702631, 702633, 702636, 702637, 702638, 702640, 702641, 702644, 702645, 702646, 702649, 702650, 702652, 702655, 702659, 702664, 702668, 702671, 702672, 702676, 702677, 702679, 702680, 702681, 702685, 702686, 702687, 702689, 702695, 702696, 702699, 702700, 702703, 702704, 702705, 702709, 702720, 702724, 702725, 702728, 702731, 702733, 702734, 702735, 702736, 702738, 702743, 702750, 702753, 702757, 702761, 702771, 702773, 702779, 702782, 702790, 702813, 702816, 702820, 702823, 702829, 702839, 702864, 702865, 702868, 702875, 702893, 702896, 702899, 702904, 702906, 702911, 702914, 702926, 702957, 702977, 702981, 702983, 702984, 702986, 702988, 702989, 703013, 703014, 703017, 703020, 703027, 703077, 703080, 703082, 703083, 703102, 703114, 703129, 703130, 703143, 703197, 703245, 703257, 703269, 703270, 703275, 703291, 703300, 703322, 703327, 703337, 703341, 703345, 703357, 703370, 703374, 703381, 703382, 703383, 703389, 703392, 703393, 703401, 703429, 703432, 703433, 703455, 703456, 703467, 703484, 703490, 703492, 703509, 703518, 703532, 703564, 703569, 703589, 703596, 703599, 703623, 703626, 703632, 703651, 703659, 703662, 703663, 703669, 703672, 703674, 703690, 703693, 703701, 703713, 703714, 703726, 703730, 703732, 703745, 703746, 703749, 703751, 703758, 703799, 703802, 703811, 703834, 703849, 703851, 703860, 703863, 703866, 703874, 703875, 703878, 703883, 703901, 703909, 703920, 703928, 703934, 703944, 703945, 703946, 703978, 703980, 703984, 704083, 704115, 704143, 704174, 704185, 704192, 704196, 704198, 704199, 704209, 704215, 704217, 704221, 704222, 704228, 704236, 704237, 704243, 704246, 704250, 704251, 704252, 704253, 704259, 704265, 704269, 704272, 704273, 704280, 704283, 704286, 704287, 704294, 704296, 704298, 704299, 704301, 704302, 704305, 704312, 704316, 704319, 704320, 704322, 704338, 704343, 704350, 704353, 704354, 704361, 704362, 704367, 704371, 704376, 704380, 704386, 704396, 704404, 704411, 704414, 704415, 704419, 704422, 704424, 704427, 704431, 704435, 704437, 704438, 704439, 704451, 704466, 704469, 704474, 704478, 704490, 704491, 704500, 704509, 704512, 704518, 704523, 704533, 704540, 704545, 704549, 704553, 704554, 704557, 704559, 704568, 704572, 704577, 704591, 704598, 704600, 704603, 704604, 704615, 704619, 704625, 704630, 704632, 704646, 704650, 704653, 704654, 704657, 704671, 704672, 704675, 704676, 704677, 704681, 704683, 704684, 704687, 704690, 704692, 704694, 704695, 704698, 704704, 704709, 704710, 704713, 704718, 704719, 704720, 704723, 704724, 704725, 704727, 704730, 704732, 704734, 704743, 704747, 704759, 704762, 704765, 704766, 704773, 704774, 704776, 704781, 704783, 704786, 704787, 704788, 704790, 704791, 704795, 704798, 704803, 704809, 704843, 704844, 704850, 704857, 704861, 704862, ...

Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00802526559082, Serial Numbers: 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023, 100024, 100026, 100029, 100034, 100037, 100038, 100040, 100041, 100045, 100046, 100047, 100049, 100054, 100057, 100061, 100066, 100068, 100071, 100072, 100073, 100074, 100083, 100085, 100093, 100097, 100100, 100103, 100104, 100109, 100112, 100121, 100122, 100124, 100125, 100135, 100136, 100138, 100140, 100147, 100153, 100156, 100162, 100163, 100165, 100166, 100168, 100170, 100171, 100181, 100197, 100205, 100214, 100222, 100235, 100237, 100268, 100270, 100271, 100272, 100273, 100280, 100281, 100288, 100295, 100302, 100309, 100324, 100328, 100337, 100339, 100354, 100359, 100360, 100363, 100369, 100372, 100377, 100384, 100386, 100387, 100391, 100400, 100403, 100404, 100410, 100411, 100413, 100415, 100421, 100423, 100431, 100432, 100434, 100435, 100438, 100439, 100440, 100443, 100460, 100473, 100488, 100491, 100492, 100496, 100502, 100504, 100510, 100526, 100534, 100535, 100536, 100539, 100546, 100547, 100548, 100549, 100551, 100552, 100556, 100561, 100567, 100581, 100584, 100585, 100587, 100588, 100592, 100593, 100598, 100599, 100602, 100604, 100605, 100606, 100610, 100613, 100619, 100623, 100629, 100630, 100634, 100639, 100640, 100644, 100647, 100650, 100653, 100661, 100663, 100666, 100669, 100674, 100681, 100682, 100686, 100688, 100692, 100694, 100696, 100698, 100702, 100708, 100713, 100719, 100720, 100722, 100724, 100728, 100730, 100737, 100742, 100743, 100749, 100750, 100754, 100756, 100757, 100762, 100764, 100765, 100768, 100773, 100774, 100778, 100783, 100785, 100791, 100794, 100797, 100815, 100823, 100826, 100827, 100828, 100831, 100832, 100839, 100840, 100841, 100847, 100848, 100853, 100854, 100855, 100856, 100860, 100861, 100864, 100885, 100886, 100887, 100899, 100902, 100905, 100906, 100907, 100908, 100917, 100920, 100921, 100928, 100929, 100934, 100937, 100938, 100940, 100941, 100943, 100944, 100949, 100951, 100956, 100957, 100960, 100962, 100969, 100975, 100978, 100983, 100985, 100986, 100987, 100988, 100989, 100991, 100994, 100997, 100999, 101007, 101013, 101014, 101015, 101016, 101018, 101020, 101025, 101033, 101037, 101039, 101047, 101048, 101049, 101053, 101054, 101058, 101060, 101061, 101065, 101069, 101074, 101075, 101076, 101077, 101078, 101079, 101082, 101084, 101087, 101088, 101089, 101094, 101100, 101101, 101102, 101104, 101107, 101108, 101110, 101115, 101117, 101121, 101122, 101124, 101129, 101131, 101136, 101137, 101138, 101139, 101140, 101141, 101143, 101144, 101145, 101146, 101149, 101158, 101159, 101160, 101164, 101167, 101169, 101172, 101174, 101177, 101179, 101181, 101182, 101190, 101192, 101194, 101196, 101205, 101206, 101207, 101217, 101223, 101229, 101230, 101234, 101236, 101238, 101239, 101240, 101243, 101244, 101247, 101250, 101253, 101256, 101257, 101258, 101259, 101262, 101265, 101268, 101274, 101283, 101287, 101291, 101292, 101306, 101309, 101311, 101318, 101321, 101322, 101325, 101336, 101337, 101343, 101348, 101357, 101358, 101386, 101392, 101396, 101397, 101398, 101402, 101406, 101408, 101418, 101419, 101420, 101421, 101423, 101424, 101426, 101427, 101433, 101434, 101447, 101448, 101453, 101454, 101457, 101460, 101472, 101486, 101489, 101491, 101492, 101493, 101498, 101499, 101500, 101501, 101502, 101504, 101506, 101507, 101509, 101516, 101518, 101519, 101521, 101531, 101532, 101534, 101535, 101536, 101537, 101539, 101540, 101543, 101550, 101554, 101556, 101563, 101571, 101573, 101575, 101576, 101586, 101589, 101591, 101598, 101608, 101609, 101610, 101612, 101620, 101630, 101641, 101655, 101700, 101704, 101711, 101742, 101828, 101835, 101857, 101862, 101868, 101877, 101878, 101886, 101889, 101902, 101924, 101932, 101961, 101969, 101971, 101979, 101986, 101989, 101995, 101999, 102001, 102004, 102012, 102016, 102018, 102019, 102021, 102025, 102027, 102030, 102033, 102036, 102038, 102040, 102041, 102044, 102055, 102058, 102061, 102062, 102063, 102065, 102069, 102072, 102073, 102074, 102075, 102078, 102091, 102093, 102094, 102096, 102098, 102100, 102101, 102102, 102103, 102106, 102107, 102111, 102112, 102114, 102117, 102120, 102123, 102124, 102125, 102126, 102127, 102128, 102130, 102131, 102132, 102135, 102149, 102159, 102167, 102171, 102172, 102174, 102187, 102190, 102191, 102192, 102194, 102200, 102232, 102238, 102239, 102242, 102244, 102267, 102302, 102308, 102309, 102313, 102317, 102319, 102323, 102325, 103468, 103473, 103475, 700013, 700014, 700025, 700035, 700096, 700103, 700104, 700208, 700221, 700225, 700226, 700237, 700243, 700245, 700247, 700249, 700257, 700264, 700279, 700283, 700292, 700299, 700316, 700321, 700326, 700328, 700337, 700340, 700341, 700342, 700344, 700376, 700402, 700413, 700416, 700419, 700436, 700437, 700438, 700447, 700450, 700451, 700452, 700458, 700460, 700467, 700468, 700469, 700470, 700471, 700474, 700475, 700476, 700479, 700481, 700484, 700486, 700488, 700490, 700491, 700492, 700502, 700504, 700506, 700508, 700510, 700517, 700518, 700519, 700524, 700531, 700537, 700538, 700540, 700541, 700545, 700551, 700552, 700555, 700559, 700566, 700569, 700571, 700575, 700579, 700586, 700594, 700596, 700599, 700603, 700604, 700605, 700619, 700660, 700661, 700685, 700712, 700721, 700725, 700733, 700737, 700745, 700754, 700762, 700763, 700764, 700766, 700767, 700770, 700771, 700784, 700788, 700790, 700791, 700794, 700798, 700801, 700805, 700807, 700811, 700814, 700816, 700818, 700819, 700826, 700827, 700829, 700832, 700833, 700834, 700842, 700857, 700859, 700860, 700863, 700868, 700869, 700871, 700873, 700879, 700895, 700897, 700898, 700901, 700906, 700907, 700908, 700910, 700911, 700912, 700913, 700917, 700926, 700931, 700933, 700935, 700941, 700991, 700994, 701001, 701021, 701022, 701025, 701026, 701027, 701031, 701036, 701038, 701043, 701045, 701048, 701051, 701053, 701057, 701058, 701061, 701062, 701065, 701071, 701072, 701076, 701080, 701082, 701086, 701088, 701091, 701093, 701098, 701100, 701111, 701115, 701121, 701136, 701137, 701138, 701144, 701156, 701160, 701175, 701186, 701188, 701191, 701194, 701208, 701209, 701215, 701223, 701234, 701235, 701255, 701262, 701267, 701278, 701282, 701285, 701288, 701289, 701290, 701298, 701300, 701303, 701304, 701315, 701317, 701320, 701334, 701343, 701350, 701354, 701355, 701364, 701365, 701373, 701374, 701375, 701385, 701404, 701409, 701411, 701413, 701420, 701422, 701430, 701432, 701437, 701439, 701446, 701447, 701449, 701450, 701455, 701460, 701462, 701475, 701484, 701485, 701486, 701490, 701495, 701498, 701504, 701509, 701518, 701520, 701521, 701522, 701523, 701532, 701536, 701539, 701543, 701550, 701555, 701556, 701561, 701562, 701567, 701577, 701578, 701580, 701587, 701592, 701596, 701602, 701604, 701605, 701606, 701608, 701610, 701613, 701625, 701626, 701627, 701628, 701632, 701634, 701636, 701641, 701646, 701648, 701654, 701655, 701665, 701670, 701673, 701674, 701679, 701681, 701683, 701687, 701689, 701690, 701694, 701699, 701701, 701702, 701703, 701705, 701706, 701708, 701710, 701713, 701717, 701720, 701728, 701731, 701733, 701737, 701741, 701743, 701752, 701753, 701755, 701756, 701763, 701772, 701774, 701777, 701779, 701781, 701784, 701787, 701789, 701791, 701792, 701793, 701804, 701806, 701813, 701814, 701822, 701825, 701827, 701828, 701829, 701831, 701834, 701835, 701836, 701839, 701840, 701841, 701848, 701850, 701852, 701862, 701867, 701868, 701872, 701876, 701877, 701881, 701884, 701890, 701891, 701895, 701896, 701897, 701903, 701906, 701911, 701919, 701921, 701926, 701928, 701929, 701932, 701945, 701946, 701948, 701949, 701951, 701953, 701957, 701961, 701962, 701971, 701972, 701978, 701979, 701985, 701986, 701994, 701996, 702002, 702003, 702008, 702010, 702011, 702014, 702020, 702022, 702025, 702026, 702028, 702032, 702047, 702054, 702055, 702057, 702067, 702078, 702081, 702088, 702093, 702095, 702097, 702102, 702106, 702109, 702111, 702113, 702114, 702118, 702124, 702125, 702130, 702131, 702145, 702146, 702148, 702156, 702157, 702160, 702162, 702165, 702169, 702170, 702174, 702175, 702184, 702185, 702189, 702196, 702201, 702204, 702208, 702212, 702213, 702214, 702215, 702217, 702219, 702229, 702240, 702243, 702248, 702252, 702265, 702266, 702267, 702274, 702276, 702277, 702283, 702286, 702292, 702295, 702297, 702298, 702299, 702300, 702301, 702322, 702336, 702338, 702339, 702349, 702351, 702353, 702361, 702363, 702368, 702372, 702378, 702399, 702400, 702403, 702405, 702407, 702410, 702411, 702412, 702413, 702415, 702419, 702420, 702422, 702427, 702428, 702430, 702433, 702438, 702440, 702441, 702443, 702447, 702448, 702449, 702450, 702451, 702453, 702457, 702459, 702460, 702461, 702462, 702463, 702468, 702469, 702470, 702473, 702478, 702481, 702485, 702491, 702492, 702493, 702496, 702497, 702500, 702504, 702506, 702507, 702508, 702509, 702511, 702512, 702515, 702517, 702518, 702524, 702525, 702527, 702529, 702531, 702532, 702533, 702540, 702545, 702547, 702550, 702551, 702553, 702554, 702555, 702556, 702558, 702559, 702561, 702563, 702567, 702571, 702578, 702581, 702582, 702585, 702586, 702590, 702596, 702598, 702599, 702600, 702601, 702602, 702604, 702606, 702611, 702613, 702614, 702617, 702620, 702624, 702626, 702627, 702628, 702630, 702631, 702633, 702636, 702637, 702638, 702640, 702641, 702644, 702645, 702646, 702649, 702650, 702652, 702655, 702659, 702664, 702668, 702671, 702672, 702676, 702677, 702679, 702680, 702681, 702685, 702686, 702687, 702689, 702695, 702696, 702699, 702700, 702703, 702704, 702705, 702709, 702720, 702724, 702725, 702728, 702731, 702733, 702734, 702735, 702736, 702738, 702743, 702750, 702753, 702757, 702761, 702771, 702773, 702779, 702782, 702790, 702813, 702816, 702820, 702823, 702829, 702839, 702864, 702865, 702868, 702875, 702893, 702896, 702899, 702904, 702906, 702911, 702914, 702926, 702957, 702977, 702981, 702983, 702984, 702986, 702988, 702989, 703013, 703014, 703017, 703020, 703027, 703077, 703080, 703082, 703083, 703102, 703114, 703129, 703130, 703143, 703197, 703245, 703257, 703269, 703270, 703275, 703291, 703300, 703322, 703327, 703337, 703341, 703345, 703357, 703370, 703374, 703381, 703382, 703383, 703389, 703392, 703393, 703401, 703429, 703432, 703433, 703455, 703456, 703467, 703484, 703490, 703492, 703509, 703518, 703532, 703564, 703569, 703589, 703596, 703599, 703623, 703626, 703632, 703651, 703659, 703662, 703663, 703669, 703672, 703674, 703690, 703693, 703701, 703713, 703714, 703726, 703730, 703732, 703745, 703746, 703749, 703751, 703758, 703799, 703802, 703811, 703834, 703849, 703851, 703860, 703863, 703866, 703874, 703875, 703878, 703883, 703901, 703909, 703920, 703928, 703934, 703944, 703945, 703946, 703978, 703980, 703984, 704083, 704115, 704143, 704174, 704185, 704192, 704196, 704198, 704199, 704209, 704215, 704217, 704221, 704222, 704228, 704236, 704237, 704243, 704246, 704250, 704251, 704252, 704253, 704259, 704265, 704269, 704272, 704273, 704280, 704283, 704286, 704287, 704294, 704296, 704298, 704299, 704301, 704302, 704305, 704312, 704316, 704319, 704320, 704322, 704338, 704343, 704350, 704353, 704354, 704361, 704362, 704367, 704371, 704376, 704380, 704386, 704396, 704404, 704411, 704414, 704415, 704419, 704422, 704424, 704427, 704431, 704435, 704437, 704438, 704439, 704451, 704466, 704469, 704474, 704478, 704490, 704491, 704500, 704509, 704512, 704518, 704523, 704533, 704540, 704545, 704549, 704553, 704554, 704557, 704559, 704568, 704572, 704577, 704591, 704598, 704600, 704603, 704604, 704615, 704619, 704625, 704630, 704632, 704646, 704650, 704653, 704654, 704657, 704671, 704672, 704675, 704676, 704677, 704681, 704683, 704684, 704687, 704690, 704692, 704694, 704695, 704698, 704704, 704709, 704710, 704713, 704718, 704719, 704720, 704723, 704724, 704725, 704727, 704730, 704732, 704734, 704743, 704747, 704759, 704762, 704765, 704766, 704773, 704774, 704776, 704781, 704783, 704786, 704787, 704788, 704790, 704791, 704795, 704798, 704803, 704809, 704843, 704844, 704850, 704857, 704861, 704862, ...

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

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Oct 22, 2025
Recall initiation date: Aug 20, 2025
Center classification date: Oct 10, 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.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records