Recall archive / FDA device enforcement

A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4... — FDA record Z-2427-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 15, 2024. 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: A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1
Reason: Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Classification: Class II
Recalling firm: Medtronic Neuromodulation
Quantity: 18,010 units
Agency-reported status: Ongoing
Source record identifier: Z-2427-2024

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	Versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). 1. Model Number 64001, GTIN (Serial Numbers): 00613994544940 (N733965, N733969, N753252, N775354, N776291, N778120, N782773); 00613994604477 (0212774778, 0212775744, 0212775759, 0212776600, 0212793056, 0212804629, 0212805718, 0212864338, 0212874932, 0212890560, 0212890575, 0212895213, 0212895214, 0212895215, 0212907133, 0212932970, 0212932973, 0212932974, 0212935897, 0213003936, 0213011214, 0213037083, 0213103554, 0213103836, 0213103947, 0213119751, 0213126252, 0213126253, 0213126254, 0213126257, 0213126258, 0213126259, 0213145327, 0213238728, 0213238729, 0213238730, 0213238731, 0213238732, 0213238733, 0213296336, 0213296338, 0213296636, 0213336983, 0213336984, 0213379975, 0213391332, 0213403188, 0213410729, 0213447187, 0213453300, 0213453301, 0213462755, 0213462757, 0213494778, 0213503190, 0213512318, 0213512796, 0213513281, 0213526864, 0213526865, 0213526866, 0213526867, 0213526868, 0213526869, 0213526870, 0213526871, 0213526872, 0213557150, 0213557151, 0213557152, 0213566074, 0213575790, 0213589299, 0213612423, 0213612424, 0213612425, 0213627695, 0213632311, 0213632313, 0213643879, 0213643880, 0213649861, 0213649862, 0213649863, 0213649865, 0213649867, 0213649868, 0213649869, 0213649870, 0213649872, 0213649873, 0213649874, 0213649875, 0213649876, 0213662356, 0213917402, 0213938623, 0213938624, 0213938625, 0213938626, 0213938638, 0214153105, 0214153106, 0214220352, 0214220353, 0214220354, 0214220355, 0214220357, 0214221962, 0214221963, 0214447748, 0214447749, 0214490072, 0214494047, 0214494053, 0214494054, 0214494055, 0214494056, 0214503001, 0214528433, 0214537122, 0214537123, 0214539376, 0214574012, 0214574462, 0214617689, 0214617821, 0214694530, 0214694659, 0214734073, 0214734078, 0214734591, 0214735109, 0214735110, 0214827966, 0214892177, 0214892179, 0214899543, 0215002059, 0215039974, 0215068207, 0215069053, 0215157787, 0215170344, 0215172048, 0215189210, 0215191813, 0215204255, 0215546041, 0215546042, 0215546043, 0215546044, 0215624458, 0215631140, 0215732518, 0215744823, 0215774217, 0215781838, 0215781840, 0215782467, 0215782468, 0215782722, 0215796016, 0215796020, 0215803678, 0215803679, 0215857526, 0215857530, 0215898037, 0215899117, 0215899118, 0216018172, 0216171381, 0216171382, 0216207616, 0216346119, 0216377773, 0216403976, 0216419016, 0216499028, 0216499029, 0216499030, 0216499031, 0216658942, 0216658943, 0216664566, 0216759284, 0216774939, 0216774940, 0216810077, 0216810078, 0216810079, 0216810080, 0216810081, 0216919717, 0216919718, 0216970034, 0216977281, 0217000199, 0217046494, 0217057275, 0217067679, 0217067680, 0217067722, 0217068512, 0217068513, 0217068514, 0217170714, 0217170715, 0217170716, 0217170717, 0217170718, 0217170719, 0217170720, 0217179190, 0217179191, 0217179192, 0217179193, 0217179195, 0217179196, 0217179197, 0217179198, 0217179199, 0217306044, 0217306045, 0217309986, 0217309987, 0217309988, 0217309989, 0217309990, 0217309991, 0217309992, 0217333857, 0217333858, 0217333859, 0217333860, 0217333861, 0217333862, 0217333863, 0217440249, 0217596169, 0217596170, 0217619906, 0217664192, 0217671944, 0217671945, 0217750243, 0217927627, 0218001371, 0218173517, 0218318172, 0218318175, 0218318178); 00613994604484 (0213209850, 0213288462, 0213293456, 0213293457, 0213293458, 0213352261, 0213419249, 0213419340, 0213473603, 0213495294, 0213495295, 0213495296, 0213495297, 0213495298, 0213495299, 0213495340, 0213495341, 0213495342, 0213559327, 0213716708, 0213766926, 0213890732, 0213890733, 0214094542, 0214311406, 0214311407, 0214311408, 0214311414, 0214311415, 0214311416, 0214311419, 0214311474, 0214311475, 0214311476, 0214311477, 0214319850, 0214319853, 0214319967, 0214319968, 0214331598, 0214331599, 0216688332, 0216812514, 0217671913, 0217826925, 0217829246, 0217829247, 0217829248); 00613994604491 (0213925833, 0214282967, 0214282968, 0214301619, 0214403827, 0214404408, 0214404409, 0214448984, 0214448987, 0214451613, 0215280226); 00643169090866 (N693604, N695628, N697903, N697905, N707785, N707814, N707818, N709873, N711340, N712986, N716557, N724809, N724820, N724826, N724838, N726518, N728574, N730697, N742633, N742635, N744671, N744678, N746637, N746640, N748178, N748179, N751469, N751477, N753246, N753250, N753252, N755339, N755413, N755415, N758481, N769619, N769621, N771699, N779249, N781452, N782773, N786955, N786955N01, N796290, N796384, N808556, N810477, N810477N01, N818532, VA1UQ8W, VA1VSZ8, VA1VXY6, VA1W50Y, VA1XYNJ, VA1ZYXF, VA20GDV, VA214QW, VA21566, VA22BQP, VA239A9, VA239AC, VA25V40, VA283DR, VA28AQV, VA28SB9, VA29QGY, VA2AQ0X, VA2AQ9F, VA2BZYK, VA2E6W7, VA2E6W9, VA2ET07, VA2FMEF, VA2UEHE); 00643169936584 (VA22LW4, VA28SB9, VA29B21, VA2BK04, VA2BZYJ, VA2BZYK, VA2FMEF, VA2S9QU); 00763000111847 (0218354155, 0218354156, 0218354157, 0218354158, 0218354159, 0218354160, 0218354161, 0218366043, 0218366044, 0218366045, 0218370795, 0218370796, 0218370797, 0218425698, 0218425699, 0218426758, 0218605857, 0218616490, 0218669761, 0218717411, 0218720328, 0218720329, 0218774777, 0218780695, 0218780696, 0218786120, 0218803244, 0218803245, 0218821512, 0218904841, 0218952397, 0218952399, 0218952401, 0218960557, 0218960559, 0218960561, 0218960563, 0219134852, 0219143990, 0219160408, 0219185911, 0219201429, 0219201440, 0219206196, 0219214603, 0219245968, 0219305171, 0219305172, 0219305173, 0219305174, 0219337011, 0219349459, 0219375530, 0219375531, 0219377400, 0219390335, 0219398981, 0219422636, 0219425617, 0219433666, 0219497903, 0219518491, 0219587572, 0219587573, 0219612248, 0219612249, 0219620526, 0219621110, 0219715005, 0219717420, 0219718438, 0219718440, 0219765247, 0219765251, 0219868602, 0219890615, 0220071933, 0220075959, 0220100014, 0220256276, 0220260478, 0220263746, 0220276913, 0220297268, 0220297270, 0220316650, 0220368431, 0220368432, 0220375984, 0220428236, 0220430237, 0220584282, 0220590246, 0220590247, 0220590248, 0220590249, 0220590250, 0220590251, 0220594791, 0220594792, 0220614692, 0220648615, 0220668846, 0221036743, 0221053170, 0221184563, 0221186755, 0221227258, 0221264033, 0221264034, 0221264960, 0221272023, 0221281956, 0221281957, 0221323103, 0221430617, 0221444627, 0221491002, 0221514322, 0221514323, 0221514324, 0221514325, 0221546530, 0221566668, 0221577081, 0221594832, 0221622517, 0221649969, 0221690470, 0221741062, 0221741063, 0221755012, 0221765184, 0221802766, 0221803888, 0221803889, 0221803890, 0221827095, 0221839656, 0221848787, 0221849670, 0221849671, 0221849672, 0221850724, 0221881224, 0221894232, 0221894233, 0221972044, 0221972045, 0221972506, 0221979343, 0222006670, 0222006671, 0222025355, 0222038363, 0222054122, 0222139672, 0222139673, 0222139674, 0222139675, 0222139676, 0222139677, 0222139678, 0222139679, 0222154978, 0222154979, 0222154980, 0222154981, 0222395543, 0222395544, 0222395545, 0222396586, 0222396587, 0222396588, 0222396589, 0222396590, 0222396591, 0222396592, 0222396593, 0222396594, 0222396595, 0222396596, 0222396597, 0222396598, 0222396599, 0222396600, 0222396601, 0222412689, 0222412690, 0222418531, 0222418532, 0222418588, 0222418589, 0222418591, 0222426616, 0222427334, 0222427335, 0222427336, 0222429509, 0222580214, 0222621260, 0222621261, 0222621262, 0222621263, 0222622281, 0222629620, 0222630230, 0222630231, 0222630232, 0222646465, 0222652428, 0222653147, 0222653148, 0222658928, 0222660622, 0222660853, 0222677422, 0222684379, 0222687577, 0222687578, 0222689822, 0222689823, 0222741781, 0222741782, 0222741783, 0222742206, 0222818437, 0222818438, 0222818439, 0222818440, 0222832453, 0222845566, 0222845585, 0222845627, 0223009455, 0223009456, 0223009457, 0223009458, 0223019858, 0223023195, 0223023200, 0223023202, 0223037118, 0223037120, 0223083064, 0223083065, 0223090114, 0223091943, 0223091944, 0223091945, 0223095856, 0223095857, 0223099274, 0223121417, 0223130455, 0223257772, 0223259688, 0223259689, 0223259690, 0223259691, 0223259692, 0223259693, 0223259694, 0223259695, 0223259696, 0223259697, 0223259698, 0223259699, 0223259700, 0223259701, 0223315885, 0223316126, 0223316130, 0223316131, 0223316132, 0223316133, 0223316134, 0223316135, 0223316136, 0223316137, 0223316140, 0223316141, 0223316142, 0223316143, 0223316144, 0223316145, 0223316166, 0223316167, 0223316168, 0223316169, 0223316170, 0223316171, 0223316172, 0223354587, 0223450726, 0223450727, 0223450728, 0223450729, 0223450730, 0223450731, 0223450732, 0223450733, 0223450734, 0223450735, 0223450736, 0223450737, 0223450738, 0223450739, 0223450740, 0223450745, 0223450746, 0223450747, 0223450748, 0223450749, 0223456972, 0223456974, 0223456975, 0223456976, 0223562242, 0223562243, 0223562244, 0223562245, 0223562246, 0223562247, 0223562248, 0223562249, 0223562250, 0223562251, 0223562252, 0223562253, 0223562254, 0223562255, 0223562256, 0223562257, 0223562258, 0223562259, 0223562260, 0223562261, 0223852618, 0223852619, 0223852620, 0223852621, 0223852622, 0223852623, 0223852624, 0223859033, 0223861157, 0223861158, 0223861160, 0223861778, 0223861779, 0223861800, 0223861814, 0223861879, 0223861880, 0223861882, 0223861939, 0223861940, 0223861949, 0223861950, 0223862582, 0223862601, 0223862609, 0223862666, 0224025144, 0224034627, 0224034666, 0224034667, 0224082804, 0224082805, 0224085442, 0224085443, 0224085444, 0224085445, 0224085586, 0224085626, 0224085627, 0224085628, 0224085629, 0224085630, 0224107431, 0224107432, 0224107434, 0224107435, 0224107436, 0224107437, 0224107439, 0224107440, 0224107441, 0224107442, 0224107443, 0224107444, 0224107445, 0224107806, 0224107808, 0224134495, 0224134496, 0224134497, 0224159135, 0224159136, 0224159137, 0224159138, 0224159139, 0224159140, 0224198334, 0224216499, 0224216563, 0224216564, 0224253258, 0224253259, 0224288640, 0224288641, 0224288642, 0224288643, 0224288644, 0224288686, 0224288687, 0224288688, 0224288689, 0224288690, 0224288691, 0224288692, 0224288693, 0224288694, 0224288695, 0224380514, 0224380515, 0224380516, 0224380517, 0224380518, 0224409896, 0224409897, 0224409899, 0224409900, 0224440199, 0224440200, 0224440201, 0224440202, 0224440203, 0224440204, 0224440205, 0224440866, 0224440867, 0224440868, 0224440869, 0224440870, 0224440871, 0224440873, 0224442313, 0224442314, 0224442315, 0224442316, 0224442317, 0224442318, 0224442319, 0224442320, 0224442321, 0224442322, 0224442323, 0224442324, 0224442325, 0224449126, 0224449127, 0224449128, 0224449129, 0224449130, 0224449131, 0224449132, 0224449133, 0224449134, 0224449135, 0224449136, 0224449137, 0224449138, 0224449139, 0224449140, 0224449141, 0224449142, 0224619284, 0224619285, 0224620226, 0224620227, 0224620228, 0224678399, 0224678400, 0224678401, 0224678564, 0224678565, 0224678906, 0224678908, 0224687409, 0224712020, 0224712021, 0224712022, 0224712023, 0224736512, 0224736513, 0224736514, 0224736515, 0224736516, 0224736517, 0224736837, 0224736838, 0224736839, 0224791803, 0224791804, 0224791805, 0224799391, 0224799392, 0224799393, 0224799394, 0224799395, 0224799396, 0224799397, 0224799398, 0224799399, 0224799400, 0224799401, 0224799402, 0224799403, 0224799806, 0224799807, 0224799808, 0224799809, 0224799810, 0224799811, 0224799812, 0224799813, 0224799814, 0224799815, 0224799816, 0224799817, 0224799818, 0224799819, 0224799820, 0224799821, 0224799822, 0224799823, 0224799824, 0224799825, 0224799826, 0224799827, 0224799828, 0224799830, 0224799831, 0224799834, 0224799835, 0224799836, 0224799837, 0224799838, 0224799839, 0225136017, 0225136018, 0225136930, 0225136931, 0225136932, 0225243969, 0225243970, 0225243973, 0225243974, 0225243975, 0225243976, 0225243977, 0225243978, 0225243979, 0225243980, 0225243981, 0225243982, 0225243983, 0225243984, 0225243985, 0225244366, 0225244367, 0225244368, 0225244369, 0225244370, 0225244371, 0225244372, 0225244373, 0225244374, 0227894725, 0227894827, 0227894828, 0227894829, 0227894832, 0227894833, 0227894834, 0227894835, 0227894836, 0227894842, 0227894843, 0227894844, 0227894845, ...

Label field

Details supplied by the agency

Lot, code or applicability

Versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). 1. Model Number 64001, GTIN (Serial Numbers): 00613994544940 (N733965, N733969, N753252, N775354, N776291, N778120, N782773); 00613994604477 (0212774778, 0212775744, 0212775759, 0212776600, 0212793056, 0212804629, 0212805718, 0212864338, 0212874932, 0212890560, 0212890575, 0212895213, 0212895214, 0212895215, 0212907133, 0212932970, 0212932973, 0212932974, 0212935897, 0213003936, 0213011214, 0213037083, 0213103554, 0213103836, 0213103947, 0213119751, 0213126252, 0213126253, 0213126254, 0213126257, 0213126258, 0213126259, 0213145327, 0213238728, 0213238729, 0213238730, 0213238731, 0213238732, 0213238733, 0213296336, 0213296338, 0213296636, 0213336983, 0213336984, 0213379975, 0213391332, 0213403188, 0213410729, 0213447187, 0213453300, 0213453301, 0213462755, 0213462757, 0213494778, 0213503190, 0213512318, 0213512796, 0213513281, 0213526864, 0213526865, 0213526866, 0213526867, 0213526868, 0213526869, 0213526870, 0213526871, 0213526872, 0213557150, 0213557151, 0213557152, 0213566074, 0213575790, 0213589299, 0213612423, 0213612424, 0213612425, 0213627695, 0213632311, 0213632313, 0213643879, 0213643880, 0213649861, 0213649862, 0213649863, 0213649865, 0213649867, 0213649868, 0213649869, 0213649870, 0213649872, 0213649873, 0213649874, 0213649875, 0213649876, 0213662356, 0213917402, 0213938623, 0213938624, 0213938625, 0213938626, 0213938638, 0214153105, 0214153106, 0214220352, 0214220353, 0214220354, 0214220355, 0214220357, 0214221962, 0214221963, 0214447748, 0214447749, 0214490072, 0214494047, 0214494053, 0214494054, 0214494055, 0214494056, 0214503001, 0214528433, 0214537122, 0214537123, 0214539376, 0214574012, 0214574462, 0214617689, 0214617821, 0214694530, 0214694659, 0214734073, 0214734078, 0214734591, 0214735109, 0214735110, 0214827966, 0214892177, 0214892179, 0214899543, 0215002059, 0215039974, 0215068207, 0215069053, 0215157787, 0215170344, 0215172048, 0215189210, 0215191813, 0215204255, 0215546041, 0215546042, 0215546043, 0215546044, 0215624458, 0215631140, 0215732518, 0215744823, 0215774217, 0215781838, 0215781840, 0215782467, 0215782468, 0215782722, 0215796016, 0215796020, 0215803678, 0215803679, 0215857526, 0215857530, 0215898037, 0215899117, 0215899118, 0216018172, 0216171381, 0216171382, 0216207616, 0216346119, 0216377773, 0216403976, 0216419016, 0216499028, 0216499029, 0216499030, 0216499031, 0216658942, 0216658943, 0216664566, 0216759284, 0216774939, 0216774940, 0216810077, 0216810078, 0216810079, 0216810080, 0216810081, 0216919717, 0216919718, 0216970034, 0216977281, 0217000199, 0217046494, 0217057275, 0217067679, 0217067680, 0217067722, 0217068512, 0217068513, 0217068514, 0217170714, 0217170715, 0217170716, 0217170717, 0217170718, 0217170719, 0217170720, 0217179190, 0217179191, 0217179192, 0217179193, 0217179195, 0217179196, 0217179197, 0217179198, 0217179199, 0217306044, 0217306045, 0217309986, 0217309987, 0217309988, 0217309989, 0217309990, 0217309991, 0217309992, 0217333857, 0217333858, 0217333859, 0217333860, 0217333861, 0217333862, 0217333863, 0217440249, 0217596169, 0217596170, 0217619906, 0217664192, 0217671944, 0217671945, 0217750243, 0217927627, 0218001371, 0218173517, 0218318172, 0218318175, 0218318178); 00613994604484 (0213209850, 0213288462, 0213293456, 0213293457, 0213293458, 0213352261, 0213419249, 0213419340, 0213473603, 0213495294, 0213495295, 0213495296, 0213495297, 0213495298, 0213495299, 0213495340, 0213495341, 0213495342, 0213559327, 0213716708, 0213766926, 0213890732, 0213890733, 0214094542, 0214311406, 0214311407, 0214311408, 0214311414, 0214311415, 0214311416, 0214311419, 0214311474, 0214311475, 0214311476, 0214311477, 0214319850, 0214319853, 0214319967, 0214319968, 0214331598, 0214331599, 0216688332, 0216812514, 0217671913, 0217826925, 0217829246, 0217829247, 0217829248); 00613994604491 (0213925833, 0214282967, 0214282968, 0214301619, 0214403827, 0214404408, 0214404409, 0214448984, 0214448987, 0214451613, 0215280226); 00643169090866 (N693604, N695628, N697903, N697905, N707785, N707814, N707818, N709873, N711340, N712986, N716557, N724809, N724820, N724826, N724838, N726518, N728574, N730697, N742633, N742635, N744671, N744678, N746637, N746640, N748178, N748179, N751469, N751477, N753246, N753250, N753252, N755339, N755413, N755415, N758481, N769619, N769621, N771699, N779249, N781452, N782773, N786955, N786955N01, N796290, N796384, N808556, N810477, N810477N01, N818532, VA1UQ8W, VA1VSZ8, VA1VXY6, VA1W50Y, VA1XYNJ, VA1ZYXF, VA20GDV, VA214QW, VA21566, VA22BQP, VA239A9, VA239AC, VA25V40, VA283DR, VA28AQV, VA28SB9, VA29QGY, VA2AQ0X, VA2AQ9F, VA2BZYK, VA2E6W7, VA2E6W9, VA2ET07, VA2FMEF, VA2UEHE); 00643169936584 (VA22LW4, VA28SB9, VA29B21, VA2BK04, VA2BZYJ, VA2BZYK, VA2FMEF, VA2S9QU); 00763000111847 (0218354155, 0218354156, 0218354157, 0218354158, 0218354159, 0218354160, 0218354161, 0218366043, 0218366044, 0218366045, 0218370795, 0218370796, 0218370797, 0218425698, 0218425699, 0218426758, 0218605857, 0218616490, 0218669761, 0218717411, 0218720328, 0218720329, 0218774777, 0218780695, 0218780696, 0218786120, 0218803244, 0218803245, 0218821512, 0218904841, 0218952397, 0218952399, 0218952401, 0218960557, 0218960559, 0218960561, 0218960563, 0219134852, 0219143990, 0219160408, 0219185911, 0219201429, 0219201440, 0219206196, 0219214603, 0219245968, 0219305171, 0219305172, 0219305173, 0219305174, 0219337011, 0219349459, 0219375530, 0219375531, 0219377400, 0219390335, 0219398981, 0219422636, 0219425617, 0219433666, 0219497903, 0219518491, 0219587572, 0219587573, 0219612248, 0219612249, 0219620526, 0219621110, 0219715005, 0219717420, 0219718438, 0219718440, 0219765247, 0219765251, 0219868602, 0219890615, 0220071933, 0220075959, 0220100014, 0220256276, 0220260478, 0220263746, 0220276913, 0220297268, 0220297270, 0220316650, 0220368431, 0220368432, 0220375984, 0220428236, 0220430237, 0220584282, 0220590246, 0220590247, 0220590248, 0220590249, 0220590250, 0220590251, 0220594791, 0220594792, 0220614692, 0220648615, 0220668846, 0221036743, 0221053170, 0221184563, 0221186755, 0221227258, 0221264033, 0221264034, 0221264960, 0221272023, 0221281956, 0221281957, 0221323103, 0221430617, 0221444627, 0221491002, 0221514322, 0221514323, 0221514324, 0221514325, 0221546530, 0221566668, 0221577081, 0221594832, 0221622517, 0221649969, 0221690470, 0221741062, 0221741063, 0221755012, 0221765184, 0221802766, 0221803888, 0221803889, 0221803890, 0221827095, 0221839656, 0221848787, 0221849670, 0221849671, 0221849672, 0221850724, 0221881224, 0221894232, 0221894233, 0221972044, 0221972045, 0221972506, 0221979343, 0222006670, 0222006671, 0222025355, 0222038363, 0222054122, 0222139672, 0222139673, 0222139674, 0222139675, 0222139676, 0222139677, 0222139678, 0222139679, 0222154978, 0222154979, 0222154980, 0222154981, 0222395543, 0222395544, 0222395545, 0222396586, 0222396587, 0222396588, 0222396589, 0222396590, 0222396591, 0222396592, 0222396593, 0222396594, 0222396595, 0222396596, 0222396597, 0222396598, 0222396599, 0222396600, 0222396601, 0222412689, 0222412690, 0222418531, 0222418532, 0222418588, 0222418589, 0222418591, 0222426616, 0222427334, 0222427335, 0222427336, 0222429509, 0222580214, 0222621260, 0222621261, 0222621262, 0222621263, 0222622281, 0222629620, 0222630230, 0222630231, 0222630232, 0222646465, 0222652428, 0222653147, 0222653148, 0222658928, 0222660622, 0222660853, 0222677422, 0222684379, 0222687577, 0222687578, 0222689822, 0222689823, 0222741781, 0222741782, 0222741783, 0222742206, 0222818437, 0222818438, 0222818439, 0222818440, 0222832453, 0222845566, 0222845585, 0222845627, 0223009455, 0223009456, 0223009457, 0223009458, 0223019858, 0223023195, 0223023200, 0223023202, 0223037118, 0223037120, 0223083064, 0223083065, 0223090114, 0223091943, 0223091944, 0223091945, 0223095856, 0223095857, 0223099274, 0223121417, 0223130455, 0223257772, 0223259688, 0223259689, 0223259690, 0223259691, 0223259692, 0223259693, 0223259694, 0223259695, 0223259696, 0223259697, 0223259698, 0223259699, 0223259700, 0223259701, 0223315885, 0223316126, 0223316130, 0223316131, 0223316132, 0223316133, 0223316134, 0223316135, 0223316136, 0223316137, 0223316140, 0223316141, 0223316142, 0223316143, 0223316144, 0223316145, 0223316166, 0223316167, 0223316168, 0223316169, 0223316170, 0223316171, 0223316172, 0223354587, 0223450726, 0223450727, 0223450728, 0223450729, 0223450730, 0223450731, 0223450732, 0223450733, 0223450734, 0223450735, 0223450736, 0223450737, 0223450738, 0223450739, 0223450740, 0223450745, 0223450746, 0223450747, 0223450748, 0223450749, 0223456972, 0223456974, 0223456975, 0223456976, 0223562242, 0223562243, 0223562244, 0223562245, 0223562246, 0223562247, 0223562248, 0223562249, 0223562250, 0223562251, 0223562252, 0223562253, 0223562254, 0223562255, 0223562256, 0223562257, 0223562258, 0223562259, 0223562260, 0223562261, 0223852618, 0223852619, 0223852620, 0223852621, 0223852622, 0223852623, 0223852624, 0223859033, 0223861157, 0223861158, 0223861160, 0223861778, 0223861779, 0223861800, 0223861814, 0223861879, 0223861880, 0223861882, 0223861939, 0223861940, 0223861949, 0223861950, 0223862582, 0223862601, 0223862609, 0223862666, 0224025144, 0224034627, 0224034666, 0224034667, 0224082804, 0224082805, 0224085442, 0224085443, 0224085444, 0224085445, 0224085586, 0224085626, 0224085627, 0224085628, 0224085629, 0224085630, 0224107431, 0224107432, 0224107434, 0224107435, 0224107436, 0224107437, 0224107439, 0224107440, 0224107441, 0224107442, 0224107443, 0224107444, 0224107445, 0224107806, 0224107808, 0224134495, 0224134496, 0224134497, 0224159135, 0224159136, 0224159137, 0224159138, 0224159139, 0224159140, 0224198334, 0224216499, 0224216563, 0224216564, 0224253258, 0224253259, 0224288640, 0224288641, 0224288642, 0224288643, 0224288644, 0224288686, 0224288687, 0224288688, 0224288689, 0224288690, 0224288691, 0224288692, 0224288693, 0224288694, 0224288695, 0224380514, 0224380515, 0224380516, 0224380517, 0224380518, 0224409896, 0224409897, 0224409899, 0224409900, 0224440199, 0224440200, 0224440201, 0224440202, 0224440203, 0224440204, 0224440205, 0224440866, 0224440867, 0224440868, 0224440869, 0224440870, 0224440871, 0224440873, 0224442313, 0224442314, 0224442315, 0224442316, 0224442317, 0224442318, 0224442319, 0224442320, 0224442321, 0224442322, 0224442323, 0224442324, 0224442325, 0224449126, 0224449127, 0224449128, 0224449129, 0224449130, 0224449131, 0224449132, 0224449133, 0224449134, 0224449135, 0224449136, 0224449137, 0224449138, 0224449139, 0224449140, 0224449141, 0224449142, 0224619284, 0224619285, 0224620226, 0224620227, 0224620228, 0224678399, 0224678400, 0224678401, 0224678564, 0224678565, 0224678906, 0224678908, 0224687409, 0224712020, 0224712021, 0224712022, 0224712023, 0224736512, 0224736513, 0224736514, 0224736515, 0224736516, 0224736517, 0224736837, 0224736838, 0224736839, 0224791803, 0224791804, 0224791805, 0224799391, 0224799392, 0224799393, 0224799394, 0224799395, 0224799396, 0224799397, 0224799398, 0224799399, 0224799400, 0224799401, 0224799402, 0224799403, 0224799806, 0224799807, 0224799808, 0224799809, 0224799810, 0224799811, 0224799812, 0224799813, 0224799814, 0224799815, 0224799816, 0224799817, 0224799818, 0224799819, 0224799820, 0224799821, 0224799822, 0224799823, 0224799824, 0224799825, 0224799826, 0224799827, 0224799828, 0224799830, 0224799831, 0224799834, 0224799835, 0224799836, 0224799837, 0224799838, 0224799839, 0225136017, 0225136018, 0225136930, 0225136931, 0225136932, 0225243969, 0225243970, 0225243973, 0225243974, 0225243975, 0225243976, 0225243977, 0225243978, 0225243979, 0225243980, 0225243981, 0225243982, 0225243983, 0225243984, 0225243985, 0225244366, 0225244367, 0225244368, 0225244369, 0225244370, 0225244371, 0225244372, 0225244373, 0225244374, 0227894725, 0227894827, 0227894828, 0227894829, 0227894832, 0227894833, 0227894834, 0227894835, 0227894836, 0227894842, 0227894843, 0227894844, 0227894845, ...

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 distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Islamic Republic Of, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Uruguay, Viet Nam.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 31, 2024
Recall initiation date: May 15, 2024
Center classification date: Jul 24, 2024

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