Recall archive / FDA device enforcement

Model Number L131, ESSENTIO DR EL MRI Pacemaker — FDA record Z-0097-2026

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 L131, ESSENTIO DR EL MRI 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: 190,088 units
Agency-reported status: Ongoing
Source record identifier: Z-0097-2026

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 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383, 102384, 102387, 102388, 102390, 102395, 102397, 102398, 102399, 102403, 102404, 102405, 102407, 102408, 102411, 102412, 102418, 102421, 102425, 102427, 102428, 102439, 102440, 102447, 102450, 102451, 102452, 102453, 102455, 102456, 102457, 102458, 102462, 102463, 102465, 102467, 102468, 102469, 102472, 102479, 102480, 102481, 102486, 102489, 102490, 102494, 102499, 102501, 102504, 102505, 102506, 102512, 102520, 102522, 102523, 102524, 102525, 102527, 102528, 102529, 102530, 102532, 102533, 102537, 102539, 102543, 102545, 102548, 102549, 102550, 102551, 102552, 102553, 102555, 102556, 102559, 102561, 102562, 102566, 102571, 102578, 102590, 102593, 102594, 102596, 102599, 102602, 102604, 102605, 102607, 102613, 102617, 102618, 102627, 102628, 102629, 102631, 102632, 102633, 102634, 110003, 110005, 110006, 110007, 110012, 110013, 110017, 110018, 110022, 110023, 110024, 110026, 110027, 110028, 110030, 110034, 110035, 110038, 110041, 110043, 110046, 110051, 110052, 110056, 110061, 110066, 110068, 110069, 110070, 110073, 110078, 110085, 110094, 110095, 110101, 110106, 110110, 110112, 110115, 110116, 110119, 110127, 110133, 110134, 110136, 110137, 110138, 110140, 110142, 110144, 110146, 110150, 110151, 110157, 110163, 110164, 110177, 110178, 110179, 110180, 110181, 110184, 110185, 110188, 110193, 110202, 110207, 110208, 110218, 110219, 110223, 110224, 110228, 110229, 110231, 110233, 110234, 110237, 110241, 110242, 110243, 110245, 110246, 110251, 110252, 110253, 110254, 110257, 110258, 110260, 110266, 110267, 110269, 110272, 110273, 110276, 110278, 110279, 110281, 110282, 110284, 110285, 110286, 110287, 110289, 110290, 110291, 110292, 110296, 110301, 110302, 110306, 110316, 110317, 110321, 110322, 110325, 110326, 110327, 110331, 110332, 110334, 110336, 110352, 110353, 110359, 110360, 110364, 110367, 110368, 110378, 110379, 110382, 110383, 110384, 110385, 110387, 110390, 110394, 110396, 110397, 110398, 110400, 110401, 110402, 110403, 110404, 110405, 110406, 110408, 110411, 110413, 110417, 110418, 110424, 110425, 110426, 110427, 110430, 110434, 110441, 110442, 110444, 110445, 110446, 110448, 110449, 110457, 110459, 110460, 110462, 110464, 110466, 110467, 110468, 110469, 110470, 110471, 110472, 110484, 110485, 110487, 110491, 110493, 110495, 110497, 110505, 110506, 110510, 110513, 110514, 110515, 110519, 110520, 110525, 110528, 110533, 110535, 110537, 110540, 110541, 110543, 110544, 110546, 110547, 110548, 110549, 110552, 110553, 110562, 110563, 110569, 110573, 110575, 110577, 110579, 110585, 110586, 110589, 110590, 110591, 110595, 110596, 110598, 110600, 110604, 110607, 110612, 110613, 110617, 110620, 110622, 110624, 110625, 110631, 110633, 110634, 110644, 110647, 110649, 110651, 110653, 110655, 110658, 110659, 110662, 110664, 110666, 110667, 110668, 110669, 110670, 110672, 110676, 110682, 110685, 110686, 110688, 110690, 110695, 110698, 110699, 110701, 110702, 110703, 110704, 110705, 110706, 110708, 110710, 110711, 110712, 110714, 110721, 110723, 110726, 110727, 110729, 110731, 110732, 110733, 110736, 110738, 110741, 110743, 110746, 110747, 110751, 110753, 110754, 110755, 110757, 110759, 110760, 110762, 110763, 110765, 110771, 110774, 110778, 110781, 110783, 110787, 110791, 110792, 110793, 110794, 110796, 110797, 110798, 110802, 110805, 110807, 110809, 110810, 110815, 110818, 110819, 110821, 110822, 110823, 110825, 110826, 110827, 110829, 110833, 110835, 110836, 110838, 110839, 110840, 110844, 110847, 110848, 110850, 110851, 110852, 110856, 110858, 110859, 110860, 110861, 110862, 110864, 110866, 110867, 110868, 110869, 110870, 110871, 110872, 110873, 110874, 110882, 110883, 110886, 110888, 110889, 110891, 110892, 110893, 110901, 110905, 110906, 110907, 110908, 110911, 110913, 110915, 110916, 110920, 110921, 110922, 110923, 110924, 110925, 110926, 110929, 110931, 110935, 110944, 110947, 110948, 110950, 110951, 110952, 110955, 110956, 110957, 110958, 110959, 110960, 110963, 110964, 110966, 110967, 110969, 110971, 110972, 110976, 110977, 110979, 110980, 110987, 110993, 110994, 110995, 110996, 110999, 111000, 111001, 111003, 111004, 111005, 111006, 111007, 111008, 111010, 111012, 111013, 111014, 111016, 111017, 111019, 111021, 111022, 111026, 111028, 111030, 111031, 111034, 111035, 111036, 111038, 111041, 111042, 111045, 111049, 111050, 111051, 111053, 111057, 111058, 111059, 111061, 111064, 111065, 111069, 111075, 111077, 111078, 111079, 111080, 111081, 111084, 111086, 111087, 111088, 111089, 111090, 111092, 111094, 111096, 111097, 111100, 111101, 111102, 111106, 111107, 111108, 111110, 111114, 111115, 111117, 111118, 111119, 111122, 111126, 111127, 111128, 111130, 111133, 111139, 111140, 111141, 111145, 111146, 111148, 111149, 111150, 111153, 111155, 111157, 111168, 111169, 111170, 111173, 111175, 111185, 111190, 111192, 111193, 111195, 111199, 111201, 111203, 111204, 111205, 111207, 111209, 111211, 111215, 111220, 111221, 111222, 111224, 111226, 111230, 111232, 111233, 111234, 111240, 111242, 111243, 111244, 111247, 111251, 111253, 111255, 111256, 111259, 111260, 111261, 111262, 111264, 111265, 111266, 111267, 111269, 111273, 111276, 111278, 111279, 111280, 111282, 111283, 111284, 111286, 111287, 111289, 111291, 111295, 111299, 111300, 111302, 111303, 111305, 111307, 111310, 111312, 111314, 111317, 111319, 111321, 111322, 111324, 111325, 111326, 111327, 111328, 111333, 111338, 111345, 111346, 111347, 111348, 111350, 111351, 111352, 111353, 111355, 111356, 111357, 111358, 111359, 111360, 111361, 111362, 111363, 111364, 111366, 111368, 111369, 111370, 111371, 111372, 111374, 111376, 111378, 111379, 111380, 111381, 111384, 111385, 111386, 111387, 111388, 111389, 111390, 111392, 111393, 111394, 111400, 111401, 111402, 111403, 111404, 111406, 111408, 111412, 111414, 111415, 111416, 111417, 111418, 111419, 111420, 111421, 111422, 111423, 111424, 111425, 111426, 111428, 111429, 111430, 111431, 111432, 111433, 111434, 111435, 111436, 111437, 111438, 111439, 111440, 111441, 111442, 111443, 111444, 111447, 111448, 111450, 111451, 111452, 111453, 111454, 111455, 111456, 111457, 111458, 111459, 111460, 111461, 111462, 111464, 111465, 111466, 111468, 111469, 111470, 111472, 111473, 111474, 111475, 111476, 111477, 111495, 111505, 111507, 111526, 111532, 111539, 111542, 111543, 111559, 111560, 111562, 111580, 111587, 111594, 111595, 111599, 111602, 111622, 111623, 111624, 111626, 111634, 111641, 111651, 111655, 111656, 111661, 111664, 111672, 111718, 111721, 111738, 111751, 111753, 111765, 111770, 111788, 111792, 111793, 111794, 111797, 111799, 111800, 111801, 111804, 111806, 111808, 111809, 111811, 111813, 111814, 111815, 111817, 111818, 111819, 111827, 111829, 111831, 111847, 111855, 111856, 111859, 111860, 111868, 111872, 111873, 111874, 111875, 111876, 111877, 111878, 111880, 111883, 111885, 111893, 111901, 111902, 111913, 111920, 111935, 111936, 111940, 111948, 111951, 111952, 111953, 111954, 111955, 111956, 111958, 111959, 111960, 111961, 111976, 111981, 111983, 111984, 111985, 111988, 111989, 111990, 111995, 112000, 112003, 112005, 112013, 112018, 112022, 112030, 112031, 112032, 112033, 112035, 112040, 112043, 112046, 112056, 112059, 112061, 112063, 112064, 112065, 112066, 112068, 112069, 112071, 112073, 112080, 112081, 112082, 112083, 112084, 112091, 112104, 112111, 112116, 112118, 112119, 112121, 112137, 112138, 112145, 112148, 112150, 112154, 112163, 112164, 112167, 112169, 112173, 112179, 112182, 112186, 112187, 112188, 112189, 112193, 112197, 112198, 112204, 112207, 112208, 112210, 112211, 112218, 112223, 112225, 112226, 112237, 112242, 112244, 112246, 112248, 112253, 112254, 112265, 112269, 112270, 112279, 112284, 112286, 112288, 112293, 112297, 112298, 112299, 112300, 112303, 112305, 112306, 112308, 112331, 112334, 112336, 112338, 112340, 112341, 112342, 112343, 112344, 112346, 112347, 112348, 112350, 112351, 112353, 112354, 112355, 112356, 112357, 112358, 112359, 112363, 112364, 112370, 112378, 112379, 112380, 112381, 112382, 112384, 112385, 112386, 112387, 112388, 112389, 112393, 112394, 112395, 112396, 112397, 112401, 112410, 112411, 112413, 112419, 112420, 112421, 112424, 112425, 112426, 112427, 112428, 112430, 112431, 112432, 112433, 112434, 112435, 112436, 112437, 112438, 112439, 112440, 112441, 112443, 112444, 112445, 112447, 112448, 112450, 112451, 112452, 112454, 112456, 112457, 112458, 112459, 112460, 112461, 112462, 112463, 112464, 112465, 112468, 112469, 112470, 112471, 112472, 112473, 112474, 112475, 112477, 112481, 112483, 112490, 112494, 112495, 112496, 112497, 112498, 112499, 112500, 112504, 112505, 112506, 112507, 112508, 112512, 112521, 112530, 112532, 112534, 112535, 112537, 112538, 112541, 112544, 112545, 112550, 112553, 112554, 112555, 112556, 112557, 112560, 112561, 112562, 112564, 112565, 112566, 112567, 112568, 112569, 112571, 112572, 112578, 112579, 112581, 112584, 112585, 112586, 112590, 112591, 112595, 112598, 112599, 112603, 112604, 112606, 112607, 112609, 112610, 112612, 112613, 112614, 112616, 112617, 112619, 112620, 112621, 112623, 112624, 112626, 112627, 112628, 112632, 112633, 112634, 112635, 112636, 112638, 112642, 112644, 112646, 112649, 112650, 112651, 112652, 112653, 112654, 112655, 112656, 112658, 112659, 112660, 112661, 112662, 112663, 112664, 112665, 112666, 112667, 112669, 112673, 112687, 112703, 112704, 112705, 112712, 112714, 112715, 112720, 112725, 112727, 112736, 112739, 112744, 112745, 112750, 112751, 112753, 112757, 112759, 112760, 112764, 112767, 112768, 112804, 112813, 112817, 112818, 112820, 112824, 112834, 112837, 112841, 112845, 112847, 112856, 112860, 112861, 112864, 112871, 112876, 112883, 112900, 112901, 112908, 112909, 112911, 112916, 112920, 112924, 112926, 112929, 112932, 112935, 112941, 112942, 112945, 112949, 112950, 112962, 112968, 112970, 112972, 112980, 112983, 112987, 112988, 112993, 112994, 113002, 113005, 113014, 113016, 113020, 113027, 113028, 113029, 113030, 113033, 113037, 113043, 113044, 113049, 113050, 113052, 113055, 113056, 113057, 113059, 113061, 113062, 113063, 113065, 113069, 113070, 113078, 113082, 113083, 113089, 113093, 113095, 113098, 113102, 113107, 113151, 113154, 113156, 113164, 113171, 113172, 113173, 113189, 113209, 113214, 113219, 113231, 113233, 113236, 113238, 113240, 113241, 113242, 113246, 113247, 113249, 113250, 113251, 113252, 113253, 113254, 113255, 113256, 113265, 113291, 113296, 113299, 113301, 113309, 113314, 113315, 113319, 113326, 113332, 113335, 113339, 113342, 113343, 113345, 113348, 113349, 113358, 113363, 113370, 113383, 113384, 113386, 113387, 113397, 113399, 113424, 113425, 113426, 113428, 113433, 113437, 113442, 113451, 113452, 113458, 113462, 113464, 113465, 113466, 113468, 113481, 113482, 113483, 113484, 113487, 113490, 113493, 113495, 113497, 113502, 113514, 113521, 113523, 113525, 113526, 113534, 113543, 113564, 113569, 113575, 113581, 113601, 113613, 113629, 113639, 113641, 113673, 113676, 113679, 113685, 113688, 113689, 113691, 113695, 113705, 113713, 113719, 113725, 113741, 113752, 113759, 113762, 113764, 113790, 113808, 113831, 113854, 113876, 113878, 113883, 113885, 113897, 113917, 113923, ...

Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00802526559266, Serial Numbers: 102068, 102071, 102072, 102074, 102086, 102089, 102091, 102092, 102094, 102095, 102097, 102101, 102102, 102104, 102108, 102115, 102120, 102122, 102124, 102129, 102145, 102146, 102149, 102157, 102175, 102176, 102181, 102187, 102188, 102189, 102191, 102194, 102195, 102196, 102197, 102198, 102202, 102203, 102205, 102206, 102207, 102208, 102211, 102212, 102213, 102215, 102218, 102221, 102223, 102226, 102227, 102228, 102235, 102240, 102241, 102244, 102250, 102253, 102258, 102259, 102262, 102268, 102270, 102271, 102275, 102281, 102282, 102283, 102284, 102285, 102286, 102288, 102289, 102294, 102304, 102308, 102310, 102312, 102318, 102319, 102320, 102321, 102322, 102328, 102330, 102331, 102332, 102334, 102336, 102338, 102339, 102341, 102342, 102345, 102348, 102352, 102359, 102360, 102365, 102366, 102369, 102372, 102376, 102377, 102381, 102382, 102383, 102384, 102387, 102388, 102390, 102395, 102397, 102398, 102399, 102403, 102404, 102405, 102407, 102408, 102411, 102412, 102418, 102421, 102425, 102427, 102428, 102439, 102440, 102447, 102450, 102451, 102452, 102453, 102455, 102456, 102457, 102458, 102462, 102463, 102465, 102467, 102468, 102469, 102472, 102479, 102480, 102481, 102486, 102489, 102490, 102494, 102499, 102501, 102504, 102505, 102506, 102512, 102520, 102522, 102523, 102524, 102525, 102527, 102528, 102529, 102530, 102532, 102533, 102537, 102539, 102543, 102545, 102548, 102549, 102550, 102551, 102552, 102553, 102555, 102556, 102559, 102561, 102562, 102566, 102571, 102578, 102590, 102593, 102594, 102596, 102599, 102602, 102604, 102605, 102607, 102613, 102617, 102618, 102627, 102628, 102629, 102631, 102632, 102633, 102634, 110003, 110005, 110006, 110007, 110012, 110013, 110017, 110018, 110022, 110023, 110024, 110026, 110027, 110028, 110030, 110034, 110035, 110038, 110041, 110043, 110046, 110051, 110052, 110056, 110061, 110066, 110068, 110069, 110070, 110073, 110078, 110085, 110094, 110095, 110101, 110106, 110110, 110112, 110115, 110116, 110119, 110127, 110133, 110134, 110136, 110137, 110138, 110140, 110142, 110144, 110146, 110150, 110151, 110157, 110163, 110164, 110177, 110178, 110179, 110180, 110181, 110184, 110185, 110188, 110193, 110202, 110207, 110208, 110218, 110219, 110223, 110224, 110228, 110229, 110231, 110233, 110234, 110237, 110241, 110242, 110243, 110245, 110246, 110251, 110252, 110253, 110254, 110257, 110258, 110260, 110266, 110267, 110269, 110272, 110273, 110276, 110278, 110279, 110281, 110282, 110284, 110285, 110286, 110287, 110289, 110290, 110291, 110292, 110296, 110301, 110302, 110306, 110316, 110317, 110321, 110322, 110325, 110326, 110327, 110331, 110332, 110334, 110336, 110352, 110353, 110359, 110360, 110364, 110367, 110368, 110378, 110379, 110382, 110383, 110384, 110385, 110387, 110390, 110394, 110396, 110397, 110398, 110400, 110401, 110402, 110403, 110404, 110405, 110406, 110408, 110411, 110413, 110417, 110418, 110424, 110425, 110426, 110427, 110430, 110434, 110441, 110442, 110444, 110445, 110446, 110448, 110449, 110457, 110459, 110460, 110462, 110464, 110466, 110467, 110468, 110469, 110470, 110471, 110472, 110484, 110485, 110487, 110491, 110493, 110495, 110497, 110505, 110506, 110510, 110513, 110514, 110515, 110519, 110520, 110525, 110528, 110533, 110535, 110537, 110540, 110541, 110543, 110544, 110546, 110547, 110548, 110549, 110552, 110553, 110562, 110563, 110569, 110573, 110575, 110577, 110579, 110585, 110586, 110589, 110590, 110591, 110595, 110596, 110598, 110600, 110604, 110607, 110612, 110613, 110617, 110620, 110622, 110624, 110625, 110631, 110633, 110634, 110644, 110647, 110649, 110651, 110653, 110655, 110658, 110659, 110662, 110664, 110666, 110667, 110668, 110669, 110670, 110672, 110676, 110682, 110685, 110686, 110688, 110690, 110695, 110698, 110699, 110701, 110702, 110703, 110704, 110705, 110706, 110708, 110710, 110711, 110712, 110714, 110721, 110723, 110726, 110727, 110729, 110731, 110732, 110733, 110736, 110738, 110741, 110743, 110746, 110747, 110751, 110753, 110754, 110755, 110757, 110759, 110760, 110762, 110763, 110765, 110771, 110774, 110778, 110781, 110783, 110787, 110791, 110792, 110793, 110794, 110796, 110797, 110798, 110802, 110805, 110807, 110809, 110810, 110815, 110818, 110819, 110821, 110822, 110823, 110825, 110826, 110827, 110829, 110833, 110835, 110836, 110838, 110839, 110840, 110844, 110847, 110848, 110850, 110851, 110852, 110856, 110858, 110859, 110860, 110861, 110862, 110864, 110866, 110867, 110868, 110869, 110870, 110871, 110872, 110873, 110874, 110882, 110883, 110886, 110888, 110889, 110891, 110892, 110893, 110901, 110905, 110906, 110907, 110908, 110911, 110913, 110915, 110916, 110920, 110921, 110922, 110923, 110924, 110925, 110926, 110929, 110931, 110935, 110944, 110947, 110948, 110950, 110951, 110952, 110955, 110956, 110957, 110958, 110959, 110960, 110963, 110964, 110966, 110967, 110969, 110971, 110972, 110976, 110977, 110979, 110980, 110987, 110993, 110994, 110995, 110996, 110999, 111000, 111001, 111003, 111004, 111005, 111006, 111007, 111008, 111010, 111012, 111013, 111014, 111016, 111017, 111019, 111021, 111022, 111026, 111028, 111030, 111031, 111034, 111035, 111036, 111038, 111041, 111042, 111045, 111049, 111050, 111051, 111053, 111057, 111058, 111059, 111061, 111064, 111065, 111069, 111075, 111077, 111078, 111079, 111080, 111081, 111084, 111086, 111087, 111088, 111089, 111090, 111092, 111094, 111096, 111097, 111100, 111101, 111102, 111106, 111107, 111108, 111110, 111114, 111115, 111117, 111118, 111119, 111122, 111126, 111127, 111128, 111130, 111133, 111139, 111140, 111141, 111145, 111146, 111148, 111149, 111150, 111153, 111155, 111157, 111168, 111169, 111170, 111173, 111175, 111185, 111190, 111192, 111193, 111195, 111199, 111201, 111203, 111204, 111205, 111207, 111209, 111211, 111215, 111220, 111221, 111222, 111224, 111226, 111230, 111232, 111233, 111234, 111240, 111242, 111243, 111244, 111247, 111251, 111253, 111255, 111256, 111259, 111260, 111261, 111262, 111264, 111265, 111266, 111267, 111269, 111273, 111276, 111278, 111279, 111280, 111282, 111283, 111284, 111286, 111287, 111289, 111291, 111295, 111299, 111300, 111302, 111303, 111305, 111307, 111310, 111312, 111314, 111317, 111319, 111321, 111322, 111324, 111325, 111326, 111327, 111328, 111333, 111338, 111345, 111346, 111347, 111348, 111350, 111351, 111352, 111353, 111355, 111356, 111357, 111358, 111359, 111360, 111361, 111362, 111363, 111364, 111366, 111368, 111369, 111370, 111371, 111372, 111374, 111376, 111378, 111379, 111380, 111381, 111384, 111385, 111386, 111387, 111388, 111389, 111390, 111392, 111393, 111394, 111400, 111401, 111402, 111403, 111404, 111406, 111408, 111412, 111414, 111415, 111416, 111417, 111418, 111419, 111420, 111421, 111422, 111423, 111424, 111425, 111426, 111428, 111429, 111430, 111431, 111432, 111433, 111434, 111435, 111436, 111437, 111438, 111439, 111440, 111441, 111442, 111443, 111444, 111447, 111448, 111450, 111451, 111452, 111453, 111454, 111455, 111456, 111457, 111458, 111459, 111460, 111461, 111462, 111464, 111465, 111466, 111468, 111469, 111470, 111472, 111473, 111474, 111475, 111476, 111477, 111495, 111505, 111507, 111526, 111532, 111539, 111542, 111543, 111559, 111560, 111562, 111580, 111587, 111594, 111595, 111599, 111602, 111622, 111623, 111624, 111626, 111634, 111641, 111651, 111655, 111656, 111661, 111664, 111672, 111718, 111721, 111738, 111751, 111753, 111765, 111770, 111788, 111792, 111793, 111794, 111797, 111799, 111800, 111801, 111804, 111806, 111808, 111809, 111811, 111813, 111814, 111815, 111817, 111818, 111819, 111827, 111829, 111831, 111847, 111855, 111856, 111859, 111860, 111868, 111872, 111873, 111874, 111875, 111876, 111877, 111878, 111880, 111883, 111885, 111893, 111901, 111902, 111913, 111920, 111935, 111936, 111940, 111948, 111951, 111952, 111953, 111954, 111955, 111956, 111958, 111959, 111960, 111961, 111976, 111981, 111983, 111984, 111985, 111988, 111989, 111990, 111995, 112000, 112003, 112005, 112013, 112018, 112022, 112030, 112031, 112032, 112033, 112035, 112040, 112043, 112046, 112056, 112059, 112061, 112063, 112064, 112065, 112066, 112068, 112069, 112071, 112073, 112080, 112081, 112082, 112083, 112084, 112091, 112104, 112111, 112116, 112118, 112119, 112121, 112137, 112138, 112145, 112148, 112150, 112154, 112163, 112164, 112167, 112169, 112173, 112179, 112182, 112186, 112187, 112188, 112189, 112193, 112197, 112198, 112204, 112207, 112208, 112210, 112211, 112218, 112223, 112225, 112226, 112237, 112242, 112244, 112246, 112248, 112253, 112254, 112265, 112269, 112270, 112279, 112284, 112286, 112288, 112293, 112297, 112298, 112299, 112300, 112303, 112305, 112306, 112308, 112331, 112334, 112336, 112338, 112340, 112341, 112342, 112343, 112344, 112346, 112347, 112348, 112350, 112351, 112353, 112354, 112355, 112356, 112357, 112358, 112359, 112363, 112364, 112370, 112378, 112379, 112380, 112381, 112382, 112384, 112385, 112386, 112387, 112388, 112389, 112393, 112394, 112395, 112396, 112397, 112401, 112410, 112411, 112413, 112419, 112420, 112421, 112424, 112425, 112426, 112427, 112428, 112430, 112431, 112432, 112433, 112434, 112435, 112436, 112437, 112438, 112439, 112440, 112441, 112443, 112444, 112445, 112447, 112448, 112450, 112451, 112452, 112454, 112456, 112457, 112458, 112459, 112460, 112461, 112462, 112463, 112464, 112465, 112468, 112469, 112470, 112471, 112472, 112473, 112474, 112475, 112477, 112481, 112483, 112490, 112494, 112495, 112496, 112497, 112498, 112499, 112500, 112504, 112505, 112506, 112507, 112508, 112512, 112521, 112530, 112532, 112534, 112535, 112537, 112538, 112541, 112544, 112545, 112550, 112553, 112554, 112555, 112556, 112557, 112560, 112561, 112562, 112564, 112565, 112566, 112567, 112568, 112569, 112571, 112572, 112578, 112579, 112581, 112584, 112585, 112586, 112590, 112591, 112595, 112598, 112599, 112603, 112604, 112606, 112607, 112609, 112610, 112612, 112613, 112614, 112616, 112617, 112619, 112620, 112621, 112623, 112624, 112626, 112627, 112628, 112632, 112633, 112634, 112635, 112636, 112638, 112642, 112644, 112646, 112649, 112650, 112651, 112652, 112653, 112654, 112655, 112656, 112658, 112659, 112660, 112661, 112662, 112663, 112664, 112665, 112666, 112667, 112669, 112673, 112687, 112703, 112704, 112705, 112712, 112714, 112715, 112720, 112725, 112727, 112736, 112739, 112744, 112745, 112750, 112751, 112753, 112757, 112759, 112760, 112764, 112767, 112768, 112804, 112813, 112817, 112818, 112820, 112824, 112834, 112837, 112841, 112845, 112847, 112856, 112860, 112861, 112864, 112871, 112876, 112883, 112900, 112901, 112908, 112909, 112911, 112916, 112920, 112924, 112926, 112929, 112932, 112935, 112941, 112942, 112945, 112949, 112950, 112962, 112968, 112970, 112972, 112980, 112983, 112987, 112988, 112993, 112994, 113002, 113005, 113014, 113016, 113020, 113027, 113028, 113029, 113030, 113033, 113037, 113043, 113044, 113049, 113050, 113052, 113055, 113056, 113057, 113059, 113061, 113062, 113063, 113065, 113069, 113070, 113078, 113082, 113083, 113089, 113093, 113095, 113098, 113102, 113107, 113151, 113154, 113156, 113164, 113171, 113172, 113173, 113189, 113209, 113214, 113219, 113231, 113233, 113236, 113238, 113240, 113241, 113242, 113246, 113247, 113249, 113250, 113251, 113252, 113253, 113254, 113255, 113256, 113265, 113291, 113296, 113299, 113301, 113309, 113314, 113315, 113319, 113326, 113332, 113335, 113339, 113342, 113343, 113345, 113348, 113349, 113358, 113363, 113370, 113383, 113384, 113386, 113387, 113397, 113399, 113424, 113425, 113426, 113428, 113433, 113437, 113442, 113451, 113452, 113458, 113462, 113464, 113465, 113466, 113468, 113481, 113482, 113483, 113484, 113487, 113490, 113493, 113495, 113497, 113502, 113514, 113521, 113523, 113525, 113526, 113534, 113543, 113564, 113569, 113575, 113581, 113601, 113613, 113629, 113639, 113641, 113673, 113676, 113679, 113685, 113688, 113689, 113691, 113695, 113705, 113713, 113719, 113725, 113741, 113752, 113759, 113762, 113764, 113790, 113808, 113831, 113854, 113876, 113878, 113883, 113885, 113897, 113917, 113923, ...

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