Recall archive / FDA device enforcement

HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with H... — FDA record Z-1570-2025

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 Mar 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: HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Reason: Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
Classification: Class I
Recalling firm: Thoratec LLC
Quantity: 1661
Agency-reported status: Ongoing
Source record identifier: Z-1570-2025

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	UDI-DI: 05415067038234. MPUs distributed between April 2024 and February 2025. Serial Numbers: 20226263, 20226264, 20226265, 20226266, 20226267, 20226268, 20226269, 20226270, 20226271, 20226272, 20226273, 20226274, 20226275, 20226276, 20226277, 20226278, 20226279, 20226280, 20226281, 20226282, 20226283, 20226284, 20226285, 20226286, 20226287, 20226288, 20226289, 20226290, 20226291, 20226292, 20240622, 20240623, 20240624, 20240625, 20240626, 20240627, 20240628, 20240629, 20240630, 20240631, 20240632, 20240633, 20240634, 20240635, 20240636, 20240637, 20240638, 20240639, 20240640, 20240641, 20240642, 20240643, 20240644, 20240645, 20240646, 20240647, 20240648, 20240649, 20240650, 20240651, 20240652, 20240653, 20240654, 20240655, 20240656, 20240657, 20240658, 20240659, 20240660, 20240661, 20240662, 20240663, 20240664, 20240665, 20240666, 20240667, 20240668, 20240669, 20240670, 20240671, 20240672, 20240673, 20240674, 20240675, 20240676, 20240677, 20240678, 20240679, 20240680, 20240681, 20240682, 20240683, 20240684, 20240685, 20240686, 20240687, 20240688, 20240689, 20240690, 20240691, 20254123, 20254124, 20254125, 20254126, 20254127, 20254128, 20254129, 20254130, 20254131, 20254132, 20254133, 20254134, 20254135, 20254136, 20254137, 20254138, 20254139, 20254140, 20254141, 20254142, 20254143, 20254144, 20254145, 20254146, 20254147, 20254148, 20254149, 20254150, 20254151, 20254152, 20254153, 20254154, 20254155, 20254156, 20254157, 20254158, 20254159, 20254160, 20254161, 20254162, 20254166, 20254167, 20254168, 20254169, 20254170, 20254171, 20254172, 20254173, 20254174, 20254175, 20254176, 20254177, 20254178, 20254179, 20254180, 20254181, 20254182, 20265454, 20265455, 20265456, 20265457, 20265458, 20265459, 20265460, 20265461, 20265462, 20265463, 20265464, 20265465, 20265466, 20265467, 20265468, 20265469, 20265470, 20265471, 20265472, 20265473, 20265474, 20265475, 20265476, 20265477, 20265478, 20265479, 20265480, 20265481, 20265483, 20265484, 20265485, 20265486, 20265487, 20265488, 20265489, 20265490, 20265491, 20265492, 20265493, 20265494, 20265495, 20265496, 20265497, 20265498, 20265499, 20265500, 20265501, 20265502, 20265503, 20265504, 20265505, 20265506, 20265507, 20265508, 20265509, 20265510, 20265511, 20265512, 20265513, 20265514, 20265515, 20265516, 20265517, 20265518, 20265519, 20265520, 20265521, 20265522, 20265523, 20265524, 20265525, 20265526, 20265527, 20265528, 20265529, 20265530, 20265531, 20265532, 20265533, 20265534, 20265535, 20265536, 20265537, 20265538, 20265539, 20265540, 20265541, 20265542, 20265543, 20265544, 20265545, 20265546, 20265547, 20265548, 20265549, 20265550, 20265551, 20265552, 20265553, 20265554, 20265555, 20265556, 20265557, 20265558, 20265559, 20265560, 20265561, 20265562, 20265563, 20265564, 20265565, 20265566, 20265567, 20265568, 20265569, 20265570, 20265571, 20265572, 20265573, 20265574, 20265576, 20265577, 20265578, 20265579, 20265580, 20265581, 20265582, 20265583, 20265584, 20265585, 20265586, 20265587, 20265588, 20265589, 20265590, 20265591, 20265592, 20265593, 20265594, 20265595, 20265596, 20265597, 20265598, 20265599, 20265600, 20265601, 20265602, 20265603, 20265604, 20265605, 20265606, 20265607, 20265608, 20265609, 20265610, 20265611, 20265612, 20265613, 20265614, 20265615, 20265616, 20265617, 20265618, 20265619, 20265620, 20265621, 20265622, 20265623, 20265624, 20265625, 20265626, 20265627, 20265628, 20265629, 20265630, 20265631, 20265632, 20265633, 20265634, 20265635, 20265636, 20265638, 20265639, 20265641, 20265642, 20265643, 20265644, 20273242, 20273243, 20273244, 20273245, 20273246, 20273247, 20273248, 20273249, 20273250, 20273251, 20273252, 20273253, 20273254, 20273255, 20273256, 20273257, 20273258, 20273259, 20273260, 20273261, 20273262, 20273263, 20273264, 20273265, 20273266, 20273267, 20273268, 20273269, 20273270, 20273271, 20285420, 20285421, 20285422, 20285423, 20285424, 20285425, 20285426, 20285427, 20285428, 20285429, 20285430, 20285431, 20285432, 20285433, 20285434, 20285435, 20285436, 20285437, 20285438, 20285439, 20285461, 20285463, 20285464, 20285465, 20285467, 20285468, 20285469, 20285470, 20285471, 20285472, 20285473, 20285475, 20285476, 20285477, 20285478, 20285479, 20285480, 20285481, 20285483, 20285484, 20285485, 20285486, 20285487, 20285488, 20285489, 20285490, 20285491, 20285492, 20285493, 20285494, 20285495, 20285496, 20285497, 20285498, 20285499, 20285500, 20285501, 20285502, 20285503, 20285569, 20285570, 20285571, 20285572, 20285573, 20285574, 20285575, 20285576, 20285577, 20285578, 20285589, 20285590, 20285591, 20285592, 20285593, 20285594, 20285595, 20285596, 20285597, 20285598, 20285599, 20285600, 20285601, 20285602, 20285603, 20285604, 20285605, 20285606, 20285608, 20285609, 20291598, 20291599, 20291600, 20291601, 20291602, 20291603, 20291604, 20291605, 20291606, 20291607, 20291608, 20291609, 20291610, 20291611, 20291612, 20291613, 20291614, 20291615, 20291616, 20291617, 20291618, 20291619, 20291620, 20291621, 20291622, 20291623, 20291624, 20291625, 20291627, 20291628, 20291629, 20291630, 20291631, 20291632, 20291633, 20291634, 20291635, 20291636, 20291637, 20293120, 20293121, 20293122, 20293123, 20293124, 20293125, 20293126, 20293127, 20293128, 20293129, 20293130, 20293131, 20293132, 20293133, 20293134, 20293135, 20293136, 20293137, 20293138, 20293139, 20293140, 20293141, 20293142, 20293143, 20293144, 20293145, 20293146, 20293147, 20293148, 20293149, 20293150, 20293151, 20293152, 20293153, 20293154, 20293155, 20293156, 20293157, 20293158, 20293159, 20296547, 20296548, 20296549, 20296550, 20296551, 20296552, 20296553, 20296555, 20296556, 20296557, 20296559, 20296560, 20296561, 20296563, 20296564, 20296565, 20296566, 20296567, 20296568, 20296569, 20296571, 20296572, 20296573, 20296574, 20296575, 20296576, 20296577, 20297159, 20297160, 20297161, 20297162, 20297163, 20297164, 20297165, 20297166, 20297167, 20297168, 20302246, 20302247, 20302248, 20302249, 20302250, 20302251, 20302252, 20302254, 20302255, 20302256, 20302257, 20302258, 20302260, 20302261, 20302262, 20302264, 20302265, 20302266, 20302267, 20302268, 20302269, 20302270, 20302272, 20302273, 20302274, 20302275, 20302276, 20302277, 20302278, 20302279, 20302280, 20302281, 20302282, 20302284, 20302285, 20302287, 20302288, 20302289, 20302290, 20302291, 20302292, 20302293, 20302294, 20302295, 20302297, 20302298, 20302299, 20302300, 20302301, 20302302, 20302303, 20302304, 20302305, 20302307, 20302308, 20302309, 20302310, 20302311, 20302312, 20302313, 20302314, 20302315, 20302316, 20302317, 20302318, 20302319, 20302320, 20302321, 20302322, 20302323, 20302324, 20302325, 20302326, 20302327, 20302328, 20302329, 20302330, 20302331, 20302332, 20302333, 20302334, 20302335, 20302336, 20302337, 20302338, 20302339, 20302340, 20302341, 20302342, 20302343, 20302344, 20302345, 20302346, 20302347, 20302348, 20302349, 20302350, 20302351, 20302352, 20302353, 20302354, 20302355, 20307844, 20307845, 20307846, 20307847, 20307848, 20307849, 20307850, 20307851, 20307852, 20307853, 20307854, 20307855, 20307856, 20307857, 20307858, 20307859, 20307860, 20307861, 20307862, 20307863, 20307864, 20307865, 20307866, 20307867, 20307868, 20307869, 20307870, 20307872, 20307873, 20307874, 20307875, 20307876, 20307877, 20307878, 20307879, 20307880, 20307881, 20307882, 20307883, 20307884, 20307885, 20307886, 20307887, 20307888, 20307889, 20307890, 20307891, 20307892, 20307893, 20307894, 20307895, 20307897, 20307898, 20307899, 20307900, 20307901, 20307902, 20307903, 20307904, 20307905, 20307906, 20307907, 20307909, 20307910, 20307911, 20307912, 20307913, 20307914, 20307915, 20307917, 20307918, 20307919, 20307920, 20307921, 20307923, 20307924, 20307926, 20307927, 20307928, 20307929, 20307930, 20307931, 20307932, 20307933, 20307934, 20307935, 20307936, 20307937, 20307938, 20307939, 20307940, 20307941, 20307942, 20307944, 20307945, 20307946, 20307948, 20307949, 20307950, 20307951, 20307952, 20307953, 20307954, 20307955, 20307957, 20307958, 20307959, 20307960, 20307961, 20307962, 20307963, 20307964, 20307965, 20307966, 20307967, 20307968, 20307969, 20307970, 20307971, 20307972, 20307973, 20307974, 20307975, 20307976, 20307977, 20307978, 20307979, 20307980, 20307981, 20307982, 20307983, 20307984, 20307985, 20307986, 20307987, 20307988, 20307990, 20307991, 20307992, 20307993, 20309412, 20309413, 20309414, 20309415, 20309417, 20309418, 20309419, 20309420, 20309421, 20309422, 20309423, 20309424, 20309425, 20309427, 20309428, 20309429, 20309430, 20309432, 20309433, 20309434, 20309435, 20309436, 20309438, 20309439, 20309440, 20309441, 20309442, 20309443, 20309444, 20309445, 20309446, 20309448, 20309449, 20309450, 20309451, 20309452, 20309453, 20309454, 20309455, 20309456, 20309457, 20309458, 20309459, 20309460, 20309461, 20309462, 20309463, 20309464, 20309465, 20309466, 20309467, 20309468, 20309469, 20309470, 20309471, 20309472, 20309473, 20309474, 20309475, 20309476, 20309477, 20309478, 20309479, 20309480, 20309481, 20309482, 20309483, 20309484, 20309485, 20309486, 20309487, 20309488, 20309489, 20309490, 20309491, 20309492, 20309493, 20309494, 20309495, 20309496, 20309497, 20309499, 20309500, 20309501, 20309502, 20309503, 20309504, 20309505, 20309506, 20309507, 20309508, 20309509, 20309510, 20309511, 20309512, 20309513, 20309514, 20309516, 20309517, 20309519, 20309520, 20309521, 20309522, 20309523, 20309524, 20309525, 20309527, 20309528, 20309529, 20309530, 20309531, 20309582, 20309583, 20309584, 20309585, 20309586, 20309587, 20309588, 20309589, 20309590, 20309591, 20309592, 20309593, 20309594, 20309595, 20309596, 20309597, 20309598, 20309599, 20309600, 20309601, 20309752, 20309753, 20309754, 20309755, 20309756, 20309757, 20309758, 20309759, 20309760, 20309761, 20314564, 20314565, 20314566, 20314567, 20314568, 20314569, 20314570, 20314571, 20314572, 20314573, 20314574, 20314575, 20314576, 20314578, 20314579, 20314580, 20314581, 20314582, 20314583, 20314584, 20314585, 20314586, 20314587, 20314588, 20314590, 20314591, 20314592, 20314593, 20314594, 20314595, 20314596, 20314597, 20314598, 20314599, 20314600, 20314601, 20314602, 20314603, 20314604, 20314605, 20314606, 20314607, 20314608, 20314609, 20314610, 20314611, 20314612, 20314613, 20314614, 20314615, 20314616, 20314617, 20314618, 20314619, 20314620, 20314621, 20314622, 20314623, 20314624, 20314625, 20314626, 20314627, 20314628, 20314629, 20314630, 20314631, 20314632, 20314633, 20314634, 20314635, 20314636, 20314637, 20314638, 20314639, 20314640, 20314641, 20314642, 20314643, 20314644, 20314645, 20314646, 20314647, 20314648, 20314649, 20314650, 20314651, 20314653, 20314654, 20314655, 20314656, 20314657, 20314658, 20314659, 20314660, 20314661, 20314662, 20314663, 20314665, 20314666, 20314667, 20314668, 20314669, 20314670, 20314671, 20314672, 20314673, 20314674, 20314675, 20314676, 20314677, 20314678, 20314679, 20314680, 20314681, 20314682, 20314683, 20314684, 20314685, 20314686, 20314687, 20314688, 20314689, 20314690, 20314691, 20314692, 20314693, 20314694, 20314695, 20314696, 20314697, 20314698, 20314699, 20314700, 20314701, 20314702, 20314703, 20326945, 20326946, 20326947, 20326948, 20326949, 20326950, 20326951, 20326952, 20326953, 20326954, 20326955, 20326956, 20326957, 20326958, 20326959, 20326960, 20326961, 20326962, 20326963, 20326964, 20326975, 20326976, 20326977, 20326978, 20326979, 20326980, 20326981, 20326982, 20326983, 20326984, 20326985, 20326986, 20326987, 20326988, 20326989, 20326990, 20326991, 20326992, 20326993, 20326994, 20326995, 20326996, 20326997, 20326998, 20326999, 20327000, 20327001, 20327002, 20327003, 20327004, 20403978, 20403979, 20403980, 20403981, 20309518, 20300942, 20326857, 20265443, 20296538, 20265436, 20226183, 20226187, 20226191, 20226192, 20226193, 20226195, 20226196, 20226197, 20226198, 20226199, 20226200, 20226201, 20226202, 20242038, 20242039, 20242040, 20242041, 20242042, 20242044, 20242045, 20242046, 20254063, 20254064, 20254065, 20254066, 20254067, 20254068, 20254069, 20254070, 20254071, 20254072, 20254083, 20...

Label field

Details supplied by the agency

Lot, code or applicability

UDI-DI: 05415067038234. MPUs distributed between April 2024 and February 2025. Serial Numbers: 20226263, 20226264, 20226265, 20226266, 20226267, 20226268, 20226269, 20226270, 20226271, 20226272, 20226273, 20226274, 20226275, 20226276, 20226277, 20226278, 20226279, 20226280, 20226281, 20226282, 20226283, 20226284, 20226285, 20226286, 20226287, 20226288, 20226289, 20226290, 20226291, 20226292, 20240622, 20240623, 20240624, 20240625, 20240626, 20240627, 20240628, 20240629, 20240630, 20240631, 20240632, 20240633, 20240634, 20240635, 20240636, 20240637, 20240638, 20240639, 20240640, 20240641, 20240642, 20240643, 20240644, 20240645, 20240646, 20240647, 20240648, 20240649, 20240650, 20240651, 20240652, 20240653, 20240654, 20240655, 20240656, 20240657, 20240658, 20240659, 20240660, 20240661, 20240662, 20240663, 20240664, 20240665, 20240666, 20240667, 20240668, 20240669, 20240670, 20240671, 20240672, 20240673, 20240674, 20240675, 20240676, 20240677, 20240678, 20240679, 20240680, 20240681, 20240682, 20240683, 20240684, 20240685, 20240686, 20240687, 20240688, 20240689, 20240690, 20240691, 20254123, 20254124, 20254125, 20254126, 20254127, 20254128, 20254129, 20254130, 20254131, 20254132, 20254133, 20254134, 20254135, 20254136, 20254137, 20254138, 20254139, 20254140, 20254141, 20254142, 20254143, 20254144, 20254145, 20254146, 20254147, 20254148, 20254149, 20254150, 20254151, 20254152, 20254153, 20254154, 20254155, 20254156, 20254157, 20254158, 20254159, 20254160, 20254161, 20254162, 20254166, 20254167, 20254168, 20254169, 20254170, 20254171, 20254172, 20254173, 20254174, 20254175, 20254176, 20254177, 20254178, 20254179, 20254180, 20254181, 20254182, 20265454, 20265455, 20265456, 20265457, 20265458, 20265459, 20265460, 20265461, 20265462, 20265463, 20265464, 20265465, 20265466, 20265467, 20265468, 20265469, 20265470, 20265471, 20265472, 20265473, 20265474, 20265475, 20265476, 20265477, 20265478, 20265479, 20265480, 20265481, 20265483, 20265484, 20265485, 20265486, 20265487, 20265488, 20265489, 20265490, 20265491, 20265492, 20265493, 20265494, 20265495, 20265496, 20265497, 20265498, 20265499, 20265500, 20265501, 20265502, 20265503, 20265504, 20265505, 20265506, 20265507, 20265508, 20265509, 20265510, 20265511, 20265512, 20265513, 20265514, 20265515, 20265516, 20265517, 20265518, 20265519, 20265520, 20265521, 20265522, 20265523, 20265524, 20265525, 20265526, 20265527, 20265528, 20265529, 20265530, 20265531, 20265532, 20265533, 20265534, 20265535, 20265536, 20265537, 20265538, 20265539, 20265540, 20265541, 20265542, 20265543, 20265544, 20265545, 20265546, 20265547, 20265548, 20265549, 20265550, 20265551, 20265552, 20265553, 20265554, 20265555, 20265556, 20265557, 20265558, 20265559, 20265560, 20265561, 20265562, 20265563, 20265564, 20265565, 20265566, 20265567, 20265568, 20265569, 20265570, 20265571, 20265572, 20265573, 20265574, 20265576, 20265577, 20265578, 20265579, 20265580, 20265581, 20265582, 20265583, 20265584, 20265585, 20265586, 20265587, 20265588, 20265589, 20265590, 20265591, 20265592, 20265593, 20265594, 20265595, 20265596, 20265597, 20265598, 20265599, 20265600, 20265601, 20265602, 20265603, 20265604, 20265605, 20265606, 20265607, 20265608, 20265609, 20265610, 20265611, 20265612, 20265613, 20265614, 20265615, 20265616, 20265617, 20265618, 20265619, 20265620, 20265621, 20265622, 20265623, 20265624, 20265625, 20265626, 20265627, 20265628, 20265629, 20265630, 20265631, 20265632, 20265633, 20265634, 20265635, 20265636, 20265638, 20265639, 20265641, 20265642, 20265643, 20265644, 20273242, 20273243, 20273244, 20273245, 20273246, 20273247, 20273248, 20273249, 20273250, 20273251, 20273252, 20273253, 20273254, 20273255, 20273256, 20273257, 20273258, 20273259, 20273260, 20273261, 20273262, 20273263, 20273264, 20273265, 20273266, 20273267, 20273268, 20273269, 20273270, 20273271, 20285420, 20285421, 20285422, 20285423, 20285424, 20285425, 20285426, 20285427, 20285428, 20285429, 20285430, 20285431, 20285432, 20285433, 20285434, 20285435, 20285436, 20285437, 20285438, 20285439, 20285461, 20285463, 20285464, 20285465, 20285467, 20285468, 20285469, 20285470, 20285471, 20285472, 20285473, 20285475, 20285476, 20285477, 20285478, 20285479, 20285480, 20285481, 20285483, 20285484, 20285485, 20285486, 20285487, 20285488, 20285489, 20285490, 20285491, 20285492, 20285493, 20285494, 20285495, 20285496, 20285497, 20285498, 20285499, 20285500, 20285501, 20285502, 20285503, 20285569, 20285570, 20285571, 20285572, 20285573, 20285574, 20285575, 20285576, 20285577, 20285578, 20285589, 20285590, 20285591, 20285592, 20285593, 20285594, 20285595, 20285596, 20285597, 20285598, 20285599, 20285600, 20285601, 20285602, 20285603, 20285604, 20285605, 20285606, 20285608, 20285609, 20291598, 20291599, 20291600, 20291601, 20291602, 20291603, 20291604, 20291605, 20291606, 20291607, 20291608, 20291609, 20291610, 20291611, 20291612, 20291613, 20291614, 20291615, 20291616, 20291617, 20291618, 20291619, 20291620, 20291621, 20291622, 20291623, 20291624, 20291625, 20291627, 20291628, 20291629, 20291630, 20291631, 20291632, 20291633, 20291634, 20291635, 20291636, 20291637, 20293120, 20293121, 20293122, 20293123, 20293124, 20293125, 20293126, 20293127, 20293128, 20293129, 20293130, 20293131, 20293132, 20293133, 20293134, 20293135, 20293136, 20293137, 20293138, 20293139, 20293140, 20293141, 20293142, 20293143, 20293144, 20293145, 20293146, 20293147, 20293148, 20293149, 20293150, 20293151, 20293152, 20293153, 20293154, 20293155, 20293156, 20293157, 20293158, 20293159, 20296547, 20296548, 20296549, 20296550, 20296551, 20296552, 20296553, 20296555, 20296556, 20296557, 20296559, 20296560, 20296561, 20296563, 20296564, 20296565, 20296566, 20296567, 20296568, 20296569, 20296571, 20296572, 20296573, 20296574, 20296575, 20296576, 20296577, 20297159, 20297160, 20297161, 20297162, 20297163, 20297164, 20297165, 20297166, 20297167, 20297168, 20302246, 20302247, 20302248, 20302249, 20302250, 20302251, 20302252, 20302254, 20302255, 20302256, 20302257, 20302258, 20302260, 20302261, 20302262, 20302264, 20302265, 20302266, 20302267, 20302268, 20302269, 20302270, 20302272, 20302273, 20302274, 20302275, 20302276, 20302277, 20302278, 20302279, 20302280, 20302281, 20302282, 20302284, 20302285, 20302287, 20302288, 20302289, 20302290, 20302291, 20302292, 20302293, 20302294, 20302295, 20302297, 20302298, 20302299, 20302300, 20302301, 20302302, 20302303, 20302304, 20302305, 20302307, 20302308, 20302309, 20302310, 20302311, 20302312, 20302313, 20302314, 20302315, 20302316, 20302317, 20302318, 20302319, 20302320, 20302321, 20302322, 20302323, 20302324, 20302325, 20302326, 20302327, 20302328, 20302329, 20302330, 20302331, 20302332, 20302333, 20302334, 20302335, 20302336, 20302337, 20302338, 20302339, 20302340, 20302341, 20302342, 20302343, 20302344, 20302345, 20302346, 20302347, 20302348, 20302349, 20302350, 20302351, 20302352, 20302353, 20302354, 20302355, 20307844, 20307845, 20307846, 20307847, 20307848, 20307849, 20307850, 20307851, 20307852, 20307853, 20307854, 20307855, 20307856, 20307857, 20307858, 20307859, 20307860, 20307861, 20307862, 20307863, 20307864, 20307865, 20307866, 20307867, 20307868, 20307869, 20307870, 20307872, 20307873, 20307874, 20307875, 20307876, 20307877, 20307878, 20307879, 20307880, 20307881, 20307882, 20307883, 20307884, 20307885, 20307886, 20307887, 20307888, 20307889, 20307890, 20307891, 20307892, 20307893, 20307894, 20307895, 20307897, 20307898, 20307899, 20307900, 20307901, 20307902, 20307903, 20307904, 20307905, 20307906, 20307907, 20307909, 20307910, 20307911, 20307912, 20307913, 20307914, 20307915, 20307917, 20307918, 20307919, 20307920, 20307921, 20307923, 20307924, 20307926, 20307927, 20307928, 20307929, 20307930, 20307931, 20307932, 20307933, 20307934, 20307935, 20307936, 20307937, 20307938, 20307939, 20307940, 20307941, 20307942, 20307944, 20307945, 20307946, 20307948, 20307949, 20307950, 20307951, 20307952, 20307953, 20307954, 20307955, 20307957, 20307958, 20307959, 20307960, 20307961, 20307962, 20307963, 20307964, 20307965, 20307966, 20307967, 20307968, 20307969, 20307970, 20307971, 20307972, 20307973, 20307974, 20307975, 20307976, 20307977, 20307978, 20307979, 20307980, 20307981, 20307982, 20307983, 20307984, 20307985, 20307986, 20307987, 20307988, 20307990, 20307991, 20307992, 20307993, 20309412, 20309413, 20309414, 20309415, 20309417, 20309418, 20309419, 20309420, 20309421, 20309422, 20309423, 20309424, 20309425, 20309427, 20309428, 20309429, 20309430, 20309432, 20309433, 20309434, 20309435, 20309436, 20309438, 20309439, 20309440, 20309441, 20309442, 20309443, 20309444, 20309445, 20309446, 20309448, 20309449, 20309450, 20309451, 20309452, 20309453, 20309454, 20309455, 20309456, 20309457, 20309458, 20309459, 20309460, 20309461, 20309462, 20309463, 20309464, 20309465, 20309466, 20309467, 20309468, 20309469, 20309470, 20309471, 20309472, 20309473, 20309474, 20309475, 20309476, 20309477, 20309478, 20309479, 20309480, 20309481, 20309482, 20309483, 20309484, 20309485, 20309486, 20309487, 20309488, 20309489, 20309490, 20309491, 20309492, 20309493, 20309494, 20309495, 20309496, 20309497, 20309499, 20309500, 20309501, 20309502, 20309503, 20309504, 20309505, 20309506, 20309507, 20309508, 20309509, 20309510, 20309511, 20309512, 20309513, 20309514, 20309516, 20309517, 20309519, 20309520, 20309521, 20309522, 20309523, 20309524, 20309525, 20309527, 20309528, 20309529, 20309530, 20309531, 20309582, 20309583, 20309584, 20309585, 20309586, 20309587, 20309588, 20309589, 20309590, 20309591, 20309592, 20309593, 20309594, 20309595, 20309596, 20309597, 20309598, 20309599, 20309600, 20309601, 20309752, 20309753, 20309754, 20309755, 20309756, 20309757, 20309758, 20309759, 20309760, 20309761, 20314564, 20314565, 20314566, 20314567, 20314568, 20314569, 20314570, 20314571, 20314572, 20314573, 20314574, 20314575, 20314576, 20314578, 20314579, 20314580, 20314581, 20314582, 20314583, 20314584, 20314585, 20314586, 20314587, 20314588, 20314590, 20314591, 20314592, 20314593, 20314594, 20314595, 20314596, 20314597, 20314598, 20314599, 20314600, 20314601, 20314602, 20314603, 20314604, 20314605, 20314606, 20314607, 20314608, 20314609, 20314610, 20314611, 20314612, 20314613, 20314614, 20314615, 20314616, 20314617, 20314618, 20314619, 20314620, 20314621, 20314622, 20314623, 20314624, 20314625, 20314626, 20314627, 20314628, 20314629, 20314630, 20314631, 20314632, 20314633, 20314634, 20314635, 20314636, 20314637, 20314638, 20314639, 20314640, 20314641, 20314642, 20314643, 20314644, 20314645, 20314646, 20314647, 20314648, 20314649, 20314650, 20314651, 20314653, 20314654, 20314655, 20314656, 20314657, 20314658, 20314659, 20314660, 20314661, 20314662, 20314663, 20314665, 20314666, 20314667, 20314668, 20314669, 20314670, 20314671, 20314672, 20314673, 20314674, 20314675, 20314676, 20314677, 20314678, 20314679, 20314680, 20314681, 20314682, 20314683, 20314684, 20314685, 20314686, 20314687, 20314688, 20314689, 20314690, 20314691, 20314692, 20314693, 20314694, 20314695, 20314696, 20314697, 20314698, 20314699, 20314700, 20314701, 20314702, 20314703, 20326945, 20326946, 20326947, 20326948, 20326949, 20326950, 20326951, 20326952, 20326953, 20326954, 20326955, 20326956, 20326957, 20326958, 20326959, 20326960, 20326961, 20326962, 20326963, 20326964, 20326975, 20326976, 20326977, 20326978, 20326979, 20326980, 20326981, 20326982, 20326983, 20326984, 20326985, 20326986, 20326987, 20326988, 20326989, 20326990, 20326991, 20326992, 20326993, 20326994, 20326995, 20326996, 20326997, 20326998, 20326999, 20327000, 20327001, 20327002, 20327003, 20327004, 20403978, 20403979, 20403980, 20403981, 20309518, 20300942, 20326857, 20265443, 20296538, 20265436, 20226183, 20226187, 20226191, 20226192, 20226193, 20226195, 20226196, 20226197, 20226198, 20226199, 20226200, 20226201, 20226202, 20242038, 20242039, 20242040, 20242041, 20242042, 20242044, 20242045, 20242046, 20254063, 20254064, 20254065, 20254066, 20254067, 20254068, 20254069, 20254070, 20254071, 20254072, 20254083, 20...

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 - US Nationwide distribution in the states of WA, NE, VA, PA, DC, KY, CA, IL, WI, TX, MA, AR, MS, MI, OH, FL, NC, TN, LA, NJ, UT, NY, DE, CT, GA, IN, AZ, OK, MO, OR, MN, SC, NM, MD, IA, KS, AL, CO, ME and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CZECH REPUBLIC, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, ISRAEL, ITALY, JAPAN, KUWAIT, LEBANON, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, ROMANIA, SERBIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UK, UNITED ARAB EMIRATES.

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: Apr 23, 2025
Recall initiation date: Mar 13, 2025
Center classification date: Apr 17, 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