Recall archive / FDA device enforcement

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4)... — FDA record Z-1322-2025

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 Feb 13, 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: Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). There are two models available fully automatic and semi-automatic. After the defibrillations pads are applied to the patient, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any rescuer assistance. The semi-automatic model evaluates the heart rhythm and requires the rescuer to press the shock button if a shockable rhythm is detected. Both models have voice and text instructions that guide the rescuer through the entire defibrillation process. Note: Not all configurations described in this document are available in all areas.
Reason: The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Classification: Class II
Recalling firm: ZOLL Medical Corporation
Quantity: 1312 units
Agency-reported status: Ongoing
Source record identifier: Z-1322-2025

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	Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9)G5S-80-L, (10) G5S-90A; UDI-DI: (1) no UDI, (2) 00812394021239, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) 00812394021413, (9) no UDI, (10) no UDI; Serial Numbers: (1) D00000154575, D00000154617, (2) D00000003725, D00000003727, D00000003734, D00000003896, D00000003898, D00000003923, D00000003927, D00000003941, D00000003943, D00000003951, D00000003955, D00000003962, D00000003964, D00000003965, D00000003968, D00000003971, D00000003972, D00000003981, D00000003982, D00000003984, D00000003987, D00000003989, D00000003991, D00000003997, D00000003999, D00000004149, D00000004151, D00000004153, D00000004154, D00000004156, D00000004158, D00000004301, D00000004304, D00000004308, D00000004313, D00000004324, D00000004329, D00000004365, D00000004390, D00000004394, D00000004402, D00000004407, D00000004408, D00000004410, D00000004413, D00000004427, D00000004441, D00000004464, D00000004509, D00000004515, D00000004516, D00000004654, D00000004658, D00000004659, D00000004669, D00000004672, D00000004673, D00000004698, D00000004703, D00000004716, D00000004841, D00000004855, D00000004857, D00000004869, D00000004880, D00000004889, D00000004891, D00000004897, D00000005194, D00000005204, D00000005207, D00000005208, D00000005218, D00000005220, D00000005230, D00000005235, D00000007936, D00000007937, D00000007938, D00000007942, D00000007961, D00000007974, D00000007981, D00000008011, D00000008013, D00000008019, D00000008021, D00000008022, D00000008023, D00000008024, D00000008049, D00000008057, D00000008148, D00000008257, D00000008263, D00000008308, D00000008310, D00000008312, D00000008887, D00000011219, D00000011221, D00000011227, D00000011232, D00000011233, D00000011234, D00000011237, D00000011242, D00000011248, D00000011252, D00000011256, D00000011299, D00000011300, D00000011301, D00000011302, D00000011303, D00000011305, D00000011306, D00000011307, D00000011311, D00000011317, D00000011330, D00000011331, D00000011374, D00000011376, D00000011377, D00000011380, D00000011381, D00000011382, D00000011383, D00000011387, D00000011388, D00000011390, D00000011392, D00000011394, D00000011395, D00000011397, D00000011399, D00000011401, D00000011403, D00000011407, D00000011411, D00000011412, D00000011413, D00000011415, D00000011418, D00000011419, D00000011421, D00000011423, D00000011426, D00000011431, D00000011433, D00000011487, D00000014123, D00000014127, D00000014130, D00000014171, D00000014211, D00000014278, D00000014294, D00000014298, D00000014334, D00000014335, D00000014354, D00000014355, D00000014356, D00000014358, D00000014360, D00000014362, D00000014364, D00000014366, D00000014370, D00000014371, D00000014373, D00000014377, D00000014381, D00000016274, D00000016286, D00000016331, D00000016333, D00000016335, D00000016336, D00000016337, D00000016338, D00000016339, D00000016340, D00000016341, D00000016342, D00000016343, D00000016344, D00000016345, D00000016346, D00000016347, D00000016348, D00000016349, D00000016350, D00000016351, D00000016352, D00000016353, D00000016354, D00000016358, D00000019102, D00000019257, D00000019259, D00000019261, D00000019264, D00000019266, D00000019267, D00000019268, D00000019272, D00000019275, D00000019276, D00000019277, D00000019282, D00000019283, D00000019285, D00000019287, D00000019288, D00000019289, D00000019292, D00000019293, D00000019294, D00000019295, D00000019296, D00000019298, D00000019299, D00000019300, D00000019302, D00000019305, D00000019306, D00000019307, D00000019314, D00000019316, D00000019336, D00000019363, D00000019385, D00000020350, D00000020351, D00000020385, D00000020386, D00000020389, D00000020393, D00000020397, D00000026374, D00000026385, D00000026427, D00000026434, D00000026435, D00000026445, D00000026446, D00000026450, D00000026452, D00000026454, D00000026458, D00000026537, D00000026538, D00000026540, D00000026541, D00000026542, D00000026543, D00000026545, D00000026548, D00000026665, D00000036480, D00000036576, D00000036580, D00000036581, D00000036588, D00000036592, D00000036605, D00000036635, D00000036639, D00000036646, D00000039846, D00000039964, D00000041408, D00000041421, D00000041926, D00000043212, D00000044698, D00000045621, D00000045637, D00000045650, D00000045694, D00000045695, D00000046159, D00000046200, D00000046201, D00000046202, D00000046204, D00000046205, D00000046206, D00000046207, D00000046211, D00000046217, D00000046218, D00000046224, D00000046236, D00000046249, D00000046254, D00000046484, D00000046526, D00000046528, D00000046561, D00000046607, D00000046608, D00000046609, D00000046610, D00000046611, D00000046612, D00000046614, D00000046615, D00000046617, D00000046619, D00000046625, D00000046629, D00000046646, D00000046653, D00000046654, D00000046657, D00000046659, D00000046681, D00000046683, D00000046685, D00000046711, D00000046714, D00000047848, D00000047855, D00000050258, D00000050262, D00000050263, D00000050919, D00000050922, D00000050925, D00000050926, D00000050927, D00000050930, D00000050931, D00000050933, D00000050936, D00000050939, D00000050941, D00000050946, D00000050948, D00000051056, D00000051722, D00000051782, D00000051784, D00000051872, D00000051884, D00000051889, D00000051891, D00000051896, D00000051898, D00000051899, D00000051901, D00000051908, D00000051935, D00000051937, D00000051938, D00000051940, D00000052006, D00000052137, D00000052145, D00000052146, D00000052148, D00000052149, D00000052151, D00000052153, D00000052154, D00000052155, D00000052156, D00000052158, D00000052160, D00000052161, D00000052163, D00000052165, D00000052167, D00000052168, D00000052169, D00000052178, D00000052186, D00000052187, D00000052188, D00000052189, D00000052190, D00000052191, D00000052195, D00000052291, D00000052292, D00000052307, D00000052437, D00000052440, D00000052461, D00000052465, D00000052469, D00000055153, D00000055185, D00000055191, D00000055200, D00000055491, D00000055499, D00000055500, D00000055501, D00000055507, D00000055536, D00000055549, D00000055699, D00000055702, D00000055704, D00000055708, D00000055711, D00000055713, D00000059397, D00000059398, D00000059399, D00000059409, D00000059418, D00000059423, D00000059425, D00000060419, D00000060435, D00000060445, D00000060454, D00000060468, D00000060475, D00000060490, D00000060513, D00000063340, D00000063346, D00000063348, D00000063349, D00000063350, D00000063352, D00000063353, D00000063355, D00000063356, D00000063357, D00000063358, D00000063359, D00000063360, D00000063361, D00000063362, D00000063364, D00000063366, D00000063367, D00000063369, D00000063371, D00000063373, D00000063377, D00000063379, D00000063381, D00000063382, D00000063384, D00000063397, D00000063398, D00000063400, D00000063402, D00000063404, D00000063405, D00000063414, D00000063421, D00000063422, D00000063425, D00000063426, D00000063427, D00000063428, D00000063429, D00000063432, D00000063433, D00000063434, D00000063440, D00000063442, D00000063445, D00000063447, D00000063452, D00000063456, D00000063458, D00000065158, D00000065522, D00000065530, D00000065538, D00000065539, D00000065540, D00000065542, D00000065545, D00000065546, D00000065550, D00000065577, D00000065631, D00000065655, D00000065656, D00000065658, D00000065660, D00000065665, D00000065667, D00000065669, D00000065671, D00000065676, D00000065677, D00000065681, D00000065683, D00000065684, D00000065688, D00000065690, D00000065693, D00000065696, D00000065697, D00000065704, D00000065706, D00000065709, D00000065710, D00000065713, D00000065721, D00000065726, D00000065727, D00000065730, D00000065806, D00000065808, D00000065810, D00000065816, D00000065818, D00000065820, D00000065821, D00000065823, D00000065824, D00000065826, D00000065829, D00000065831, D00000065832, D00000065848, D00000065850, D00000065852, D00000065854, D00000065856, D00000065858, D00000065860, D00000065862, D00000065864, D00000065865, D00000065867, D00000065869, D00000065870, D00000065873, D00000065875, D00000065877, D00000065879, D00000065881, D00000065883, D00000065884, D00000065885, D00000065886, D00000065888, D00000065892, D00000065977, D00000066820, D00000066821, D00000066838, D00000066839, D00000066840, D00000068109, D00000068110, D00000068111, D00000068112, D00000068118, D00000068168, D00000068173, D00000068184, D00000068199, D00000068202, D00000068203, D00000068208, D00000068240, D00000068268, D00000068336, D00000068363, D00000068364, D00000069656, D00000069713, D00000069716, D00000069719, D00000069730, D00000070389, D00000070392, D00000070393, D00000070394, D00000070395, D00000070396, D00000070397, D00000070403, D00000070404, D00000070405, D00000070406, D00000070407, D00000070408, D00000070409, D00000070410, D00000070411, D00000070412, D00000070413, D00000070414, D00000070415, D00000070416, D00000070417, D00000070420, D00000070423, D00000070424, D00000070425, D00000071463, D00000071464, D00000071465, D00000071467, D00000071468, D00000071469, D00000071493, D00000073630, D00000073632, D00000073634, D00000073645, D00000073682, D00000073686, D00000073702, D00000073705, D00000073708, D00000073712, D00000073717, D00000073751, D00000073753, D00000073754, D00000074161, D00000074167, D00000074170, D00000074174, D00000074177, D00000074181, D00000074184, D00000074186, D00000074189, D00000074195, D00000074197, D00000074212, D00000074215, D00000074229, D00000074233, D00000075868, D00000075899, D00000075907, D00000075908, D00000075910, D00000075911, D00000075913, D00000075914, D00000075915, D00000075916, D00000075917, D00000075922, D00000075936, D00000075938, D00000075947, D00000075989, D00000076485, D00000076544, D00000076548, D00000077177, D00000077190, D00000077367, D00000077813, D00000077831, D00000077953, D00000077980, D00000078064, D00000078114, D00000078149, D00000078226, D00000078305, D00000078306, D00000078312, D00000078314, D00000078315, D00000078316, D00000078317, D00000078318, D00000078319, D00000078330, D00000078338, D00000078339, D00000079644, D00000079649, D00000079655, D00000079657, D00000079659, D00000080675, D00000080676, D00000080677, D00000080696, D00000080703, D00000080732, D00000080734, D00000082312, D00000082315, D00000082317, D00000082320, D00000082321, D00000082322, D00000082393, D00000082398, D00000084702, D00000084712, D00000084736, D00000084738, D00000086444, D00000086460, D00000086463, D00000086477, D00000086484, D00000086495, D00000086497, D00000087498, D00000087596, D00000087610, D00000087620, D00000087622, D00000087624, D00000087630, D00000087633, D00000087638, D00000087640, D00000087644, D00000087660, D00000087662, D00000087664, D00000087666, D00000087675, D00000087686, D00000087692, D00000087695, D00000087696, D00000087697, D00000087699, D00000087700, D00000087701, D00000087703, D00000087709, D00000087712, D00000087713, D00000087714, D00000087721, D00000087724, D00000087726, D00000087731, D00000087732, D00000087733, D00000087734, D00000087735, D00000087737, D00000087738, D00000087740, D00000087746, D00000087748, D00000087750, D00000087751, D00000087753, D00000087754, D00000087756, D00000087758, D00000087762, D00000087764, D00000089450, D00000089452, D00000089463, D00000089476, D00000089896, D00000089912, D00000089916, D00000089959, D00000089970, D00000089999, D00000090022, D00000090023, D00000090025, D00000090026, D00000090027, D00000090030, D00000090031, D00000090032, D00000090033, D00000090034, D00000090035, D00000090036, D00000090037, D00000090038, D00000090039, D00000090041, D00000090042, D00000090043, D00000090044, D00000090045, D00000090047, D00000090048, D00000090049, D00000090050, D00000090051, D00000090052, D00000090053, D00000090054, D00000090055, D00000090057, D00000090058, D00000090060, D00000090061, D00000090063, D00000090066, D00000090067, D00000090068, D00000090069, D00000090070, D00000090071, D00000090072, D00000090076, D00000090077, D00000090079, D00000090081, D00000090082, D00000090087, D00000090089, D00000090115, D00000092343, D00000092362, D00000092475, D00000092486, D00000094040, D00000094061, D0000...

Label field

Details supplied by the agency

Lot, code or applicability

Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9)G5S-80-L, (10) G5S-90A; UDI-DI: (1) no UDI, (2) 00812394021239, (3) no UDI, (4) no UDI, (5) no UDI, (6) no UDI, (7) no UDI, (8) 00812394021413, (9) no UDI, (10) no UDI; Serial Numbers: (1) D00000154575, D00000154617, (2) D00000003725, D00000003727, D00000003734, D00000003896, D00000003898, D00000003923, D00000003927, D00000003941, D00000003943, D00000003951, D00000003955, D00000003962, D00000003964, D00000003965, D00000003968, D00000003971, D00000003972, D00000003981, D00000003982, D00000003984, D00000003987, D00000003989, D00000003991, D00000003997, D00000003999, D00000004149, D00000004151, D00000004153, D00000004154, D00000004156, D00000004158, D00000004301, D00000004304, D00000004308, D00000004313, D00000004324, D00000004329, D00000004365, D00000004390, D00000004394, D00000004402, D00000004407, D00000004408, D00000004410, D00000004413, D00000004427, D00000004441, D00000004464, D00000004509, D00000004515, D00000004516, D00000004654, D00000004658, D00000004659, D00000004669, D00000004672, D00000004673, D00000004698, D00000004703, D00000004716, D00000004841, D00000004855, D00000004857, D00000004869, D00000004880, D00000004889, D00000004891, D00000004897, D00000005194, D00000005204, D00000005207, D00000005208, D00000005218, D00000005220, D00000005230, D00000005235, D00000007936, D00000007937, D00000007938, D00000007942, D00000007961, D00000007974, D00000007981, D00000008011, D00000008013, D00000008019, D00000008021, D00000008022, D00000008023, D00000008024, D00000008049, D00000008057, D00000008148, D00000008257, D00000008263, D00000008308, D00000008310, D00000008312, D00000008887, D00000011219, D00000011221, D00000011227, D00000011232, D00000011233, D00000011234, D00000011237, D00000011242, D00000011248, D00000011252, D00000011256, D00000011299, D00000011300, D00000011301, D00000011302, D00000011303, D00000011305, D00000011306, D00000011307, D00000011311, D00000011317, D00000011330, D00000011331, D00000011374, D00000011376, D00000011377, D00000011380, D00000011381, D00000011382, D00000011383, D00000011387, D00000011388, D00000011390, D00000011392, D00000011394, D00000011395, D00000011397, D00000011399, D00000011401, D00000011403, D00000011407, D00000011411, D00000011412, D00000011413, D00000011415, D00000011418, D00000011419, D00000011421, D00000011423, D00000011426, D00000011431, D00000011433, D00000011487, D00000014123, D00000014127, D00000014130, D00000014171, D00000014211, D00000014278, D00000014294, D00000014298, D00000014334, D00000014335, D00000014354, D00000014355, D00000014356, D00000014358, D00000014360, D00000014362, D00000014364, D00000014366, D00000014370, D00000014371, D00000014373, D00000014377, D00000014381, D00000016274, D00000016286, D00000016331, D00000016333, D00000016335, D00000016336, D00000016337, D00000016338, D00000016339, D00000016340, D00000016341, D00000016342, D00000016343, D00000016344, D00000016345, D00000016346, D00000016347, D00000016348, D00000016349, D00000016350, D00000016351, D00000016352, D00000016353, D00000016354, D00000016358, D00000019102, D00000019257, D00000019259, D00000019261, D00000019264, D00000019266, D00000019267, D00000019268, D00000019272, D00000019275, D00000019276, D00000019277, D00000019282, D00000019283, D00000019285, D00000019287, D00000019288, D00000019289, D00000019292, D00000019293, D00000019294, D00000019295, D00000019296, D00000019298, D00000019299, D00000019300, D00000019302, D00000019305, D00000019306, D00000019307, D00000019314, D00000019316, D00000019336, D00000019363, D00000019385, D00000020350, D00000020351, D00000020385, D00000020386, D00000020389, D00000020393, D00000020397, D00000026374, D00000026385, D00000026427, D00000026434, D00000026435, D00000026445, D00000026446, D00000026450, D00000026452, D00000026454, D00000026458, D00000026537, D00000026538, D00000026540, D00000026541, D00000026542, D00000026543, D00000026545, D00000026548, D00000026665, D00000036480, D00000036576, D00000036580, D00000036581, D00000036588, D00000036592, D00000036605, D00000036635, D00000036639, D00000036646, D00000039846, D00000039964, D00000041408, D00000041421, D00000041926, D00000043212, D00000044698, D00000045621, D00000045637, D00000045650, D00000045694, D00000045695, D00000046159, D00000046200, D00000046201, D00000046202, D00000046204, D00000046205, D00000046206, D00000046207, D00000046211, D00000046217, D00000046218, D00000046224, D00000046236, D00000046249, D00000046254, D00000046484, D00000046526, D00000046528, D00000046561, D00000046607, D00000046608, D00000046609, D00000046610, D00000046611, D00000046612, D00000046614, D00000046615, D00000046617, D00000046619, D00000046625, D00000046629, D00000046646, D00000046653, D00000046654, D00000046657, D00000046659, D00000046681, D00000046683, D00000046685, D00000046711, D00000046714, D00000047848, D00000047855, D00000050258, D00000050262, D00000050263, D00000050919, D00000050922, D00000050925, D00000050926, D00000050927, D00000050930, D00000050931, D00000050933, D00000050936, D00000050939, D00000050941, D00000050946, D00000050948, D00000051056, D00000051722, D00000051782, D00000051784, D00000051872, D00000051884, D00000051889, D00000051891, D00000051896, D00000051898, D00000051899, D00000051901, D00000051908, D00000051935, D00000051937, D00000051938, D00000051940, D00000052006, D00000052137, D00000052145, D00000052146, D00000052148, D00000052149, D00000052151, D00000052153, D00000052154, D00000052155, D00000052156, D00000052158, D00000052160, D00000052161, D00000052163, D00000052165, D00000052167, D00000052168, D00000052169, D00000052178, D00000052186, D00000052187, D00000052188, D00000052189, D00000052190, D00000052191, D00000052195, D00000052291, D00000052292, D00000052307, D00000052437, D00000052440, D00000052461, D00000052465, D00000052469, D00000055153, D00000055185, D00000055191, D00000055200, D00000055491, D00000055499, D00000055500, D00000055501, D00000055507, D00000055536, D00000055549, D00000055699, D00000055702, D00000055704, D00000055708, D00000055711, D00000055713, D00000059397, D00000059398, D00000059399, D00000059409, D00000059418, D00000059423, D00000059425, D00000060419, D00000060435, D00000060445, D00000060454, D00000060468, D00000060475, D00000060490, D00000060513, D00000063340, D00000063346, D00000063348, D00000063349, D00000063350, D00000063352, D00000063353, D00000063355, D00000063356, D00000063357, D00000063358, D00000063359, D00000063360, D00000063361, D00000063362, D00000063364, D00000063366, D00000063367, D00000063369, D00000063371, D00000063373, D00000063377, D00000063379, D00000063381, D00000063382, D00000063384, D00000063397, D00000063398, D00000063400, D00000063402, D00000063404, D00000063405, D00000063414, D00000063421, D00000063422, D00000063425, D00000063426, D00000063427, D00000063428, D00000063429, D00000063432, D00000063433, D00000063434, D00000063440, D00000063442, D00000063445, D00000063447, D00000063452, D00000063456, D00000063458, D00000065158, D00000065522, D00000065530, D00000065538, D00000065539, D00000065540, D00000065542, D00000065545, D00000065546, D00000065550, D00000065577, D00000065631, D00000065655, D00000065656, D00000065658, D00000065660, D00000065665, D00000065667, D00000065669, D00000065671, D00000065676, D00000065677, D00000065681, D00000065683, D00000065684, D00000065688, D00000065690, D00000065693, D00000065696, D00000065697, D00000065704, D00000065706, D00000065709, D00000065710, D00000065713, D00000065721, D00000065726, D00000065727, D00000065730, D00000065806, D00000065808, D00000065810, D00000065816, D00000065818, D00000065820, D00000065821, D00000065823, D00000065824, D00000065826, D00000065829, D00000065831, D00000065832, D00000065848, D00000065850, D00000065852, D00000065854, D00000065856, D00000065858, D00000065860, D00000065862, D00000065864, D00000065865, D00000065867, D00000065869, D00000065870, D00000065873, D00000065875, D00000065877, D00000065879, D00000065881, D00000065883, D00000065884, D00000065885, D00000065886, D00000065888, D00000065892, D00000065977, D00000066820, D00000066821, D00000066838, D00000066839, D00000066840, D00000068109, D00000068110, D00000068111, D00000068112, D00000068118, D00000068168, D00000068173, D00000068184, D00000068199, D00000068202, D00000068203, D00000068208, D00000068240, D00000068268, D00000068336, D00000068363, D00000068364, D00000069656, D00000069713, D00000069716, D00000069719, D00000069730, D00000070389, D00000070392, D00000070393, D00000070394, D00000070395, D00000070396, D00000070397, D00000070403, D00000070404, D00000070405, D00000070406, D00000070407, D00000070408, D00000070409, D00000070410, D00000070411, D00000070412, D00000070413, D00000070414, D00000070415, D00000070416, D00000070417, D00000070420, D00000070423, D00000070424, D00000070425, D00000071463, D00000071464, D00000071465, D00000071467, D00000071468, D00000071469, D00000071493, D00000073630, D00000073632, D00000073634, D00000073645, D00000073682, D00000073686, D00000073702, D00000073705, D00000073708, D00000073712, D00000073717, D00000073751, D00000073753, D00000073754, D00000074161, D00000074167, D00000074170, D00000074174, D00000074177, D00000074181, D00000074184, D00000074186, D00000074189, D00000074195, D00000074197, D00000074212, D00000074215, D00000074229, D00000074233, D00000075868, D00000075899, D00000075907, D00000075908, D00000075910, D00000075911, D00000075913, D00000075914, D00000075915, D00000075916, D00000075917, D00000075922, D00000075936, D00000075938, D00000075947, D00000075989, D00000076485, D00000076544, D00000076548, D00000077177, D00000077190, D00000077367, D00000077813, D00000077831, D00000077953, D00000077980, D00000078064, D00000078114, D00000078149, D00000078226, D00000078305, D00000078306, D00000078312, D00000078314, D00000078315, D00000078316, D00000078317, D00000078318, D00000078319, D00000078330, D00000078338, D00000078339, D00000079644, D00000079649, D00000079655, D00000079657, D00000079659, D00000080675, D00000080676, D00000080677, D00000080696, D00000080703, D00000080732, D00000080734, D00000082312, D00000082315, D00000082317, D00000082320, D00000082321, D00000082322, D00000082393, D00000082398, D00000084702, D00000084712, D00000084736, D00000084738, D00000086444, D00000086460, D00000086463, D00000086477, D00000086484, D00000086495, D00000086497, D00000087498, D00000087596, D00000087610, D00000087620, D00000087622, D00000087624, D00000087630, D00000087633, D00000087638, D00000087640, D00000087644, D00000087660, D00000087662, D00000087664, D00000087666, D00000087675, D00000087686, D00000087692, D00000087695, D00000087696, D00000087697, D00000087699, D00000087700, D00000087701, D00000087703, D00000087709, D00000087712, D00000087713, D00000087714, D00000087721, D00000087724, D00000087726, D00000087731, D00000087732, D00000087733, D00000087734, D00000087735, D00000087737, D00000087738, D00000087740, D00000087746, D00000087748, D00000087750, D00000087751, D00000087753, D00000087754, D00000087756, D00000087758, D00000087762, D00000087764, D00000089450, D00000089452, D00000089463, D00000089476, D00000089896, D00000089912, D00000089916, D00000089959, D00000089970, D00000089999, D00000090022, D00000090023, D00000090025, D00000090026, D00000090027, D00000090030, D00000090031, D00000090032, D00000090033, D00000090034, D00000090035, D00000090036, D00000090037, D00000090038, D00000090039, D00000090041, D00000090042, D00000090043, D00000090044, D00000090045, D00000090047, D00000090048, D00000090049, D00000090050, D00000090051, D00000090052, D00000090053, D00000090054, D00000090055, D00000090057, D00000090058, D00000090060, D00000090061, D00000090063, D00000090066, D00000090067, D00000090068, D00000090069, D00000090070, D00000090071, D00000090072, D00000090076, D00000090077, D00000090079, D00000090081, D00000090082, D00000090087, D00000090089, D00000090115, D00000092343, D00000092362, D00000092475, D00000092486, D00000094040, D00000094061, D0000...

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

Domestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD, BE, BG, BH, BM, BN, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GH, GU, HK, HR, HU, ID, IE, IL, IN, IS, IT, JE, JM, JP, KR, KW, KZ, LB, LT, MA, MC, MD, ME, MQ, MS, MT, MX, MY, NC, NG, NL, NO, NZ, OM, PA, PE, PG, PH, PK, PL, PR, PT, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, SM, TC, TH, TN, TR, TW, UA, US, VG, ZA.

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: Mar 19, 2025
Recall initiation date: Feb 13, 2025
Center classification date: Mar 12, 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