Recall archive / FDA device enforcement

Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A... — FDA record Z-1316-2025

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) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO. 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: 2268 units
Agency-reported status: Ongoing
Source record identifier: Z-1316-2025

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) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO; UDI-DI: (1) no UDI, (2) 00812394021154, (3) no UDI, (4) no UDI, (5) 00812394022243, (6) 00812394021192, (7) 00812394021390; Serial Numbers: (1) D00000177884, D00000177917, D00000177931, D00000177956, D00000178271, D00000178311, D00000178395, D00000178542, M00000002041, M00000008225, M00000008290, M00000008336, (2) D00000003482, D00000003546, D00000003557, D00000003600, D00000003625, D00000003783, D00000003978, D00000003983, D00000003985, D00000004036, D00000004037, D00000004040, D00000004043, D00000004089, D00000004098, D00000004100, D00000004105, D00000004107, D00000004109, D00000004111, D00000004116, D00000004118, D00000004119, D00000004120, D00000004123, D00000004129, D00000004131, D00000004132, D00000004133, D00000004138, D00000004140, D00000004141, D00000004142, D00000004143, D00000004145, D00000004146, D00000004147, D00000004148, D00000004150, D00000004155, D00000004157, D00000004159, D00000004160, D00000004161, D00000004162, D00000004163, D00000004164, D00000004165, D00000004166, D00000004167, D00000004168, D00000004169, D00000004170, D00000004171, D00000004172, D00000004173, D00000004174, D00000004175, D00000004176, D00000004177, D00000004178, D00000004179, D00000004180, D00000004181, D00000004182, D00000004183, D00000004184, D00000004185, D00000004186, D00000004187, D00000004188, D00000004189, D00000004190, D00000004191, D00000004192, D00000004193, D00000004194, D00000004196, D00000004199, D00000004201, D00000004203, D00000004204, D00000004205, D00000004206, D00000004207, D00000004208, D00000004209, D00000004211, D00000004213, D00000004214, D00000004215, D00000004216, D00000004217, D00000004219, D00000004221, D00000004224, D00000004225, D00000004227, D00000004229, D00000004230, D00000004233, D00000004235, D00000004238, D00000004240, D00000004241, D00000004242, D00000004243, D00000004246, D00000004247, D00000004248, D00000004249, D00000004257, D00000004258, D00000004259, D00000004261, D00000004262, D00000004266, D00000004267, D00000004268, D00000004269, D00000004270, D00000004271, D00000004272, D00000004273, D00000004274, D00000004276, D00000004277, D00000004278, D00000004279, D00000004280, D00000004281, D00000004282, D00000004283, D00000004284, D00000004285, D00000004286, D00000004287, D00000004288, D00000004289, D00000004290, D00000004291, D00000004292, D00000004293, D00000004294, D00000004295, D00000004297, D00000004298, D00000004299, D00000004302, D00000004305, D00000004311, D00000004312, D00000004314, D00000004316, D00000004319, D00000004320, D00000004322, D00000004325, D00000004326, D00000004328, D00000004331, D00000004332, D00000004333, D00000004334, D00000004335, D00000004336, D00000004337, D00000004338, D00000004339, D00000004340, D00000004341, D00000004343, D00000004344, D00000004345, D00000004347, D00000004348, D00000004349, D00000004350, D00000004351, D00000004353, D00000004355, D00000004356, D00000004358, D00000004359, D00000004361, D00000004362, D00000004363, D00000004364, D00000004366, D00000004367, D00000004368, D00000004369, D00000004371, D00000004372, D00000004373, D00000004374, D00000004375, D00000004376, D00000004379, D00000004381, D00000004384, D00000004389, D00000004393, D00000004403, D00000004419, D00000004425, D00000004431, D00000004434, D00000004435, D00000004437, D00000004438, D00000004448, D00000004451, D00000004455, D00000004457, D00000004458, D00000004460, D00000004466, D00000004475, D00000004481, D00000004488, D00000004501, D00000004517, D00000004519, D00000004528, D00000004532, D00000004533, D00000004536, D00000004537, D00000004539, D00000004541, D00000004544, D00000004545, D00000004547, D00000004548, D00000004549, D00000004550, D00000004552, D00000004553, D00000004554, D00000004557, D00000004558, D00000004559, D00000004561, D00000004562, D00000004565, D00000004567, D00000004568, D00000004569, D00000004570, D00000004571, D00000004574, D00000004576, D00000004577, D00000004578, D00000004583, D00000004584, D00000004586, D00000004587, D00000004590, D00000004592, D00000004593, D00000004599, D00000004600, D00000004603, D00000004606, D00000004609, D00000004611, D00000004612, D00000004613, D00000004615, D00000004616, D00000004617, D00000004618, D00000004619, D00000004620, D00000004621, D00000004622, D00000004623, D00000004624, D00000004625, D00000004626, D00000004627, D00000004628, D00000004629, D00000004630, D00000004631, D00000004632, D00000004633, D00000004635, D00000004636, D00000004637, D00000004639, D00000004641, D00000004643, D00000004644, D00000004755, D00000004757, D00000004759, D00000004760, D00000004768, D00000004811, D00000005416, D00000005419, D00000005423, D00000005424, D00000005425, D00000005426, D00000005427, D00000005428, D00000005429, D00000005430, D00000006873, D00000006874, D00000006875, D00000006876, D00000006877, D00000006968, D00000007022, D00000007043, D00000007106, D00000007108, D00000007138, D00000007141, D00000007143, D00000007145, D00000007146, D00000007153, D00000007158, D00000007160, D00000007162, D00000007166, D00000007168, D00000007265, D00000007288, D00000007331, D00000007332, D00000007335, D00000007341, D00000007349, D00000007354, D00000007369, D00000007370, D00000007372, D00000007389, D00000008242, D00000008243, D00000008246, D00000008252, D00000008325, D00000008818, D00000008819, D00000008820, D00000008821, D00000008822, D00000008823, D00000008828, D00000008832, D00000008833, D00000008835, D00000008836, D00000008839, D00000008848, D00000008851, D00000008852, D00000008853, D00000008854, D00000008855, D00000008856, D00000008857, D00000008858, D00000008859, D00000008862, D00000008863, D00000008864, D00000008867, D00000008873, D00000008876, D00000008877, D00000008878, D00000008880, D00000008883, D00000008884, D00000008885, D00000008888, D00000008889, D00000008890, D00000008891, D00000008892, D00000008893, D00000008896, D00000008898, D00000008899, D00000008901, D00000008902, D00000008903, D00000008904, D00000008906, D00000008910, D00000008915, D00000008920, D00000008943, D00000008972, D00000008974, D00000008977, D00000008979, D00000008981, D00000008982, D00000008984, D00000008986, D00000008987, D00000008988, D00000008990, D00000008991, D00000008997, D00000009158, D00000009160, D00000009161, D00000009162, D00000009164, D00000009165, D00000009198, D00000009200, D00000009206, D00000009208, D00000009209, D00000009210, D00000009211, D00000009212, D00000009224, D00000009226, D00000009228, D00000009229, D00000009246, D00000009250, D00000010138, D00000010163, D00000010165, D00000010166, D00000010167, D00000010176, D00000010177, D00000010179, D00000010180, D00000010182, D00000010183, D00000010185, D00000010186, D00000010287, D00000010290, D00000010293, D00000010294, D00000010295, D00000010296, D00000010297, D00000010299, D00000010300, D00000010301, D00000010302, D00000010312, D00000010313, D00000010314, D00000010315, D00000010316, D00000010317, D00000010319, D00000010352, D00000010353, D00000010354, D00000010361, D00000011113, D00000011121, D00000011130, D00000011138, D00000011139, D00000012025, D00000012681, D00000012726, D00000013788, D00000013806, D00000013810, D00000013812, D00000013813, D00000013815, D00000013831, D00000013834, D00000013836, D00000013839, D00000013841, D00000013843, D00000013844, D00000013845, D00000013892, D00000013913, D00000013914, D00000013915, D00000013917, D00000013921, D00000013924, D00000013925, D00000013928, D00000013929, D00000013930, D00000013931, D00000013932, D00000013933, D00000013934, D00000013935, D00000013936, D00000013937, D00000013938, D00000013941, D00000013942, D00000013943, D00000013944, D00000013945, D00000013959, D00000013962, D00000013963, D00000013964, D00000013965, D00000013966, D00000013967, D00000013968, D00000013969, D00000013970, D00000013971, D00000013972, D00000013973, D00000013974, D00000013975, D00000013976, D00000013977, D00000013978, D00000013979, D00000013980, D00000013981, D00000013982, D00000013983, D00000013984, D00000013985, D00000013987, D00000013988, D00000013990, D00000013991, D00000013994, D00000013995, D00000013997, D00000013998, D00000013999, D00000014000, D00000014001, D00000014003, D00000014006, D00000014008, D00000014010, D00000016171, D00000016184, D00000016190, D00000016204, D00000016221, D00000016238, D00000016239, D00000016240, D00000016241, D00000016242, D00000016243, D00000016244, D00000016246, D00000016249, D00000016252, D00000016254, D00000016256, D00000016259, D00000016317, D00000016319, D00000016323, D00000016324, D00000016325, D00000016326, D00000016328, D00000016329, D00000016330, D00000016332, D00000016334, D00000016456, D00000016468, D00000016806, D00000019311, D00000019326, D00000019335, D00000019337, D00000019340, D00000019341, D00000019342, D00000019345, D00000019347, D00000019351, D00000019352, D00000019354, D00000019355, D00000019358, D00000019361, D00000019362, D00000019366, D00000019367, D00000019368, D00000019372, D00000019373, D00000019380, D00000019381, D00000019399, D00000019401, D00000019403, D00000019405, D00000019407, D00000019414, D00000019427, D00000019429, D00000019433, D00000019440, D00000019443, D00000019447, D00000022047, D00000022048, D00000022049, D00000022118, D00000022139, D00000022142, D00000022143, D00000022144, D00000022145, D00000022146, D00000022148, D00000022149, D00000022150, D00000022151, D00000022152, D00000022153, D00000022154, D00000022155, D00000022156, D00000022157, D00000022158, D00000022159, D00000022160, D00000022161, D00000022162, D00000022163, D00000022164, D00000022165, D00000022166, D00000022167, D00000022168, D00000022169, D00000022170, D00000022171, D00000022172, D00000022173, D00000022174, D00000022175, D00000022176, D00000022177, D00000022178, D00000022179, D00000022180, D00000022181, D00000022182, D00000022183, D00000022184, D00000022185, D00000022186, D00000022187, D00000022188, D00000022189, D00000022190, D00000022191, D00000022192, D00000022193, D00000022194, D00000022195, D00000022196, D00000022197, D00000022198, D00000022199, D00000022200, D00000022201, D00000022202, D00000022203, D00000022204, D00000022205, D00000022206, D00000022207, D00000022208, D00000022209, D00000022210, D00000022212, D00000022213, D00000022214, D00000022215, D00000022216, D00000022217, D00000022218, D00000022219, D00000022220, D00000022221, D00000022223, D00000022224, D00000022225, D00000022228, D00000022229, D00000022230, D00000022231, D00000022232, D00000022233, D00000022234, D00000022235, D00000022236, D00000022237, D00000022238, D00000022239, D00000022243, D00000022245, D00000022246, D00000022247, D00000022248, D00000022254, D00000024969, D00000025372, D00000025433, D00000025434, D00000025442, D00000025446, D00000025447, D00000025448, D00000025449, D00000025450, D00000025451, D00000025452, D00000025454, D00000025456, D00000025458, D00000025460, D00000025462, D00000025463, D00000025464, D00000025465, D00000025467, D00000025468, D00000025470, D00000025471, D00000025472, D00000025473, D00000025475, D00000025476, D00000025478, D00000025479, D00000025481, D00000025483, D00000025484, D00000025485, D00000025489, D00000025491, D00000025492, D00000025493, D00000025494, D00000025495, D00000025496, D00000025497, D00000025500, D00000025501, D00000025503, D00000025505, D00000025507, D00000025508, D00000025518, D00000025524, D00000025525, D00000025529, D00000025534, D00000026391, D00000026525, D00000026526, D00000026527, D00000026528, D00000026621, D00000026622, D00000026627, D00000026633, D00000026634, D00000026635, D00000026636, D00000026637, D00000026638, D00000026639, D00000026640, D00000026642, D00000026645, D00000026646, D00000026647, D00000026649, D00000026650, D00000026652, D00000026654, D00000026659, D00000026660, D00000026663, D00000026713, D00000028976, D00000029066, D00000029111, D00000029124, D00000029130, D00000029145, D00000029151, D00000029163, D00000029180, D00000029184, D00000029187, D00000029202, D00000029203, D00000029205, D00000029214, D00000029217, D00000029223, D00000029224, ...

Label field

Details supplied by the agency

Lot, code or applicability

Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, (3) G5A-02A, (4) G5A-03A, (5) G5A-19A, (6) G5A-80A, (7) G5A-80A-TSO; UDI-DI: (1) no UDI, (2) 00812394021154, (3) no UDI, (4) no UDI, (5) 00812394022243, (6) 00812394021192, (7) 00812394021390; Serial Numbers: (1) D00000177884, D00000177917, D00000177931, D00000177956, D00000178271, D00000178311, D00000178395, D00000178542, M00000002041, M00000008225, M00000008290, M00000008336, (2) D00000003482, D00000003546, D00000003557, D00000003600, D00000003625, D00000003783, D00000003978, D00000003983, D00000003985, D00000004036, D00000004037, D00000004040, D00000004043, D00000004089, D00000004098, D00000004100, D00000004105, D00000004107, D00000004109, D00000004111, D00000004116, D00000004118, D00000004119, D00000004120, D00000004123, D00000004129, D00000004131, D00000004132, D00000004133, D00000004138, D00000004140, D00000004141, D00000004142, D00000004143, D00000004145, D00000004146, D00000004147, D00000004148, D00000004150, D00000004155, D00000004157, D00000004159, D00000004160, D00000004161, D00000004162, D00000004163, D00000004164, D00000004165, D00000004166, D00000004167, D00000004168, D00000004169, D00000004170, D00000004171, D00000004172, D00000004173, D00000004174, D00000004175, D00000004176, D00000004177, D00000004178, D00000004179, D00000004180, D00000004181, D00000004182, D00000004183, D00000004184, D00000004185, D00000004186, D00000004187, D00000004188, D00000004189, D00000004190, D00000004191, D00000004192, D00000004193, D00000004194, D00000004196, D00000004199, D00000004201, D00000004203, D00000004204, D00000004205, D00000004206, D00000004207, D00000004208, D00000004209, D00000004211, D00000004213, D00000004214, D00000004215, D00000004216, D00000004217, D00000004219, D00000004221, D00000004224, D00000004225, D00000004227, D00000004229, D00000004230, D00000004233, D00000004235, D00000004238, D00000004240, D00000004241, D00000004242, D00000004243, D00000004246, D00000004247, D00000004248, D00000004249, D00000004257, D00000004258, D00000004259, D00000004261, D00000004262, D00000004266, D00000004267, D00000004268, D00000004269, D00000004270, D00000004271, D00000004272, D00000004273, D00000004274, D00000004276, D00000004277, D00000004278, D00000004279, D00000004280, D00000004281, D00000004282, D00000004283, D00000004284, D00000004285, D00000004286, D00000004287, D00000004288, D00000004289, D00000004290, D00000004291, D00000004292, D00000004293, D00000004294, D00000004295, D00000004297, D00000004298, D00000004299, D00000004302, D00000004305, D00000004311, D00000004312, D00000004314, D00000004316, D00000004319, D00000004320, D00000004322, D00000004325, D00000004326, D00000004328, D00000004331, D00000004332, D00000004333, D00000004334, D00000004335, D00000004336, D00000004337, D00000004338, D00000004339, D00000004340, D00000004341, D00000004343, D00000004344, D00000004345, D00000004347, D00000004348, D00000004349, D00000004350, D00000004351, D00000004353, D00000004355, D00000004356, D00000004358, D00000004359, D00000004361, D00000004362, D00000004363, D00000004364, D00000004366, D00000004367, D00000004368, D00000004369, D00000004371, D00000004372, D00000004373, D00000004374, D00000004375, D00000004376, D00000004379, D00000004381, D00000004384, D00000004389, D00000004393, D00000004403, D00000004419, D00000004425, D00000004431, D00000004434, D00000004435, D00000004437, D00000004438, D00000004448, D00000004451, D00000004455, D00000004457, D00000004458, D00000004460, D00000004466, D00000004475, D00000004481, D00000004488, D00000004501, D00000004517, D00000004519, D00000004528, D00000004532, D00000004533, D00000004536, D00000004537, D00000004539, D00000004541, D00000004544, D00000004545, D00000004547, D00000004548, D00000004549, D00000004550, D00000004552, D00000004553, D00000004554, D00000004557, D00000004558, D00000004559, D00000004561, D00000004562, D00000004565, D00000004567, D00000004568, D00000004569, D00000004570, D00000004571, D00000004574, D00000004576, D00000004577, D00000004578, D00000004583, D00000004584, D00000004586, D00000004587, D00000004590, D00000004592, D00000004593, D00000004599, D00000004600, D00000004603, D00000004606, D00000004609, D00000004611, D00000004612, D00000004613, D00000004615, D00000004616, D00000004617, D00000004618, D00000004619, D00000004620, D00000004621, D00000004622, D00000004623, D00000004624, D00000004625, D00000004626, D00000004627, D00000004628, D00000004629, D00000004630, D00000004631, D00000004632, D00000004633, D00000004635, D00000004636, D00000004637, D00000004639, D00000004641, D00000004643, D00000004644, D00000004755, D00000004757, D00000004759, D00000004760, D00000004768, D00000004811, D00000005416, D00000005419, D00000005423, D00000005424, D00000005425, D00000005426, D00000005427, D00000005428, D00000005429, D00000005430, D00000006873, D00000006874, D00000006875, D00000006876, D00000006877, D00000006968, D00000007022, D00000007043, D00000007106, D00000007108, D00000007138, D00000007141, D00000007143, D00000007145, D00000007146, D00000007153, D00000007158, D00000007160, D00000007162, D00000007166, D00000007168, D00000007265, D00000007288, D00000007331, D00000007332, D00000007335, D00000007341, D00000007349, D00000007354, D00000007369, D00000007370, D00000007372, D00000007389, D00000008242, D00000008243, D00000008246, D00000008252, D00000008325, D00000008818, D00000008819, D00000008820, D00000008821, D00000008822, D00000008823, D00000008828, D00000008832, D00000008833, D00000008835, D00000008836, D00000008839, D00000008848, D00000008851, D00000008852, D00000008853, D00000008854, D00000008855, D00000008856, D00000008857, D00000008858, D00000008859, D00000008862, D00000008863, D00000008864, D00000008867, D00000008873, D00000008876, D00000008877, D00000008878, D00000008880, D00000008883, D00000008884, D00000008885, D00000008888, D00000008889, D00000008890, D00000008891, D00000008892, D00000008893, D00000008896, D00000008898, D00000008899, D00000008901, D00000008902, D00000008903, D00000008904, D00000008906, D00000008910, D00000008915, D00000008920, D00000008943, D00000008972, D00000008974, D00000008977, D00000008979, D00000008981, D00000008982, D00000008984, D00000008986, D00000008987, D00000008988, D00000008990, D00000008991, D00000008997, D00000009158, D00000009160, D00000009161, D00000009162, D00000009164, D00000009165, D00000009198, D00000009200, D00000009206, D00000009208, D00000009209, D00000009210, D00000009211, D00000009212, D00000009224, D00000009226, D00000009228, D00000009229, D00000009246, D00000009250, D00000010138, D00000010163, D00000010165, D00000010166, D00000010167, D00000010176, D00000010177, D00000010179, D00000010180, D00000010182, D00000010183, D00000010185, D00000010186, D00000010287, D00000010290, D00000010293, D00000010294, D00000010295, D00000010296, D00000010297, D00000010299, D00000010300, D00000010301, D00000010302, D00000010312, D00000010313, D00000010314, D00000010315, D00000010316, D00000010317, D00000010319, D00000010352, D00000010353, D00000010354, D00000010361, D00000011113, D00000011121, D00000011130, D00000011138, D00000011139, D00000012025, D00000012681, D00000012726, D00000013788, D00000013806, D00000013810, D00000013812, D00000013813, D00000013815, D00000013831, D00000013834, D00000013836, D00000013839, D00000013841, D00000013843, D00000013844, D00000013845, D00000013892, D00000013913, D00000013914, D00000013915, D00000013917, D00000013921, D00000013924, D00000013925, D00000013928, D00000013929, D00000013930, D00000013931, D00000013932, D00000013933, D00000013934, D00000013935, D00000013936, D00000013937, D00000013938, D00000013941, D00000013942, D00000013943, D00000013944, D00000013945, D00000013959, D00000013962, D00000013963, D00000013964, D00000013965, D00000013966, D00000013967, D00000013968, D00000013969, D00000013970, D00000013971, D00000013972, D00000013973, D00000013974, D00000013975, D00000013976, D00000013977, D00000013978, D00000013979, D00000013980, D00000013981, D00000013982, D00000013983, D00000013984, D00000013985, D00000013987, D00000013988, D00000013990, D00000013991, D00000013994, D00000013995, D00000013997, D00000013998, D00000013999, D00000014000, D00000014001, D00000014003, D00000014006, D00000014008, D00000014010, D00000016171, D00000016184, D00000016190, D00000016204, D00000016221, D00000016238, D00000016239, D00000016240, D00000016241, D00000016242, D00000016243, D00000016244, D00000016246, D00000016249, D00000016252, D00000016254, D00000016256, D00000016259, D00000016317, D00000016319, D00000016323, D00000016324, D00000016325, D00000016326, D00000016328, D00000016329, D00000016330, D00000016332, D00000016334, D00000016456, D00000016468, D00000016806, D00000019311, D00000019326, D00000019335, D00000019337, D00000019340, D00000019341, D00000019342, D00000019345, D00000019347, D00000019351, D00000019352, D00000019354, D00000019355, D00000019358, D00000019361, D00000019362, D00000019366, D00000019367, D00000019368, D00000019372, D00000019373, D00000019380, D00000019381, D00000019399, D00000019401, D00000019403, D00000019405, D00000019407, D00000019414, D00000019427, D00000019429, D00000019433, D00000019440, D00000019443, D00000019447, D00000022047, D00000022048, D00000022049, D00000022118, D00000022139, D00000022142, D00000022143, D00000022144, D00000022145, D00000022146, D00000022148, D00000022149, D00000022150, D00000022151, D00000022152, D00000022153, D00000022154, D00000022155, D00000022156, D00000022157, D00000022158, D00000022159, D00000022160, D00000022161, D00000022162, D00000022163, D00000022164, D00000022165, D00000022166, D00000022167, D00000022168, D00000022169, D00000022170, D00000022171, D00000022172, D00000022173, D00000022174, D00000022175, D00000022176, D00000022177, D00000022178, D00000022179, D00000022180, D00000022181, D00000022182, D00000022183, D00000022184, D00000022185, D00000022186, D00000022187, D00000022188, D00000022189, D00000022190, D00000022191, D00000022192, D00000022193, D00000022194, D00000022195, D00000022196, D00000022197, D00000022198, D00000022199, D00000022200, D00000022201, D00000022202, D00000022203, D00000022204, D00000022205, D00000022206, D00000022207, D00000022208, D00000022209, D00000022210, D00000022212, D00000022213, D00000022214, D00000022215, D00000022216, D00000022217, D00000022218, D00000022219, D00000022220, D00000022221, D00000022223, D00000022224, D00000022225, D00000022228, D00000022229, D00000022230, D00000022231, D00000022232, D00000022233, D00000022234, D00000022235, D00000022236, D00000022237, D00000022238, D00000022239, D00000022243, D00000022245, D00000022246, D00000022247, D00000022248, D00000022254, D00000024969, D00000025372, D00000025433, D00000025434, D00000025442, D00000025446, D00000025447, D00000025448, D00000025449, D00000025450, D00000025451, D00000025452, D00000025454, D00000025456, D00000025458, D00000025460, D00000025462, D00000025463, D00000025464, D00000025465, D00000025467, D00000025468, D00000025470, D00000025471, D00000025472, D00000025473, D00000025475, D00000025476, D00000025478, D00000025479, D00000025481, D00000025483, D00000025484, D00000025485, D00000025489, D00000025491, D00000025492, D00000025493, D00000025494, D00000025495, D00000025496, D00000025497, D00000025500, D00000025501, D00000025503, D00000025505, D00000025507, D00000025508, D00000025518, D00000025524, D00000025525, D00000025529, D00000025534, D00000026391, D00000026525, D00000026526, D00000026527, D00000026528, D00000026621, D00000026622, D00000026627, D00000026633, D00000026634, D00000026635, D00000026636, D00000026637, D00000026638, D00000026639, D00000026640, D00000026642, D00000026645, D00000026646, D00000026647, D00000026649, D00000026650, D00000026652, D00000026654, D00000026659, D00000026660, D00000026663, D00000026713, D00000028976, D00000029066, D00000029111, D00000029124, D00000029130, D00000029145, D00000029151, D00000029163, D00000029180, D00000029184, D00000029187, D00000029202, D00000029203, D00000029205, D00000029214, D00000029217, D00000029223, D00000029224, ...

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

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