Recall archive / FDA device enforcement

HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE — FDA record Z-1512-2022

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 Jun 28, 2022. 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: HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Reason: Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Classification: Class I
Recalling firm: Heartware, Inc.
Quantity: 19616 batteries
Agency-reported status: Ongoing
Source record identifier: Z-1512-2022

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	a. GTIN 00763000187767, Serial Numbers: BAT941874, BAT941880, BAT941886, BAT941935, BAT941937, BAT941944, BAT941948, BAT941960, BAT942348, BAT941747, BAT941897, BAT941955, BAT941959, BAT937852, BAT937853, BAT937887, BAT937889, BAT937893, BAT941119, BAT941132, BAT941148, BAT941962, BAT941976, BAT941988, BAT942254, BAT937888, BAT937890, BAT941133, BAT941145, BAT941147, BAT941149, BAT941303, BAT941963, BAT941965, BAT940874, BAT941024, BAT942202, BAT942217, BAT942241, BAT942270, BAT942272, BAT942199, BAT942203, BAT942212, BAT942214, BAT942218, BAT942222, BAT942224, BAT942242, BAT942248, BAT942267, BAT942271, BAT942273, BAT942311, BAT942329, BAT939092, BAT939174, BAT939176, BAT939178, BAT941257, BAT941259, BAT941263, BAT939173, BAT939175, BAT939177, BAT940999, BAT941262, BAT942204, BAT942206, BAT942236, BAT942240, BAT939078, BAT939086, BAT939088, BAT942256, BAT942262, BAT942264, BAT942266, BAT939075, BAT939079, BAT939085, BAT942261, BAT942265, BAT817284, BAT817286, BAT817290, BAT817295, BAT901435, BAT937553, BAT937555, BAT937557, BAT817283, BAT817285, BAT817287, BAT817296, BAT901437, BAT905645, BAT937554, BAT937556, BAT817154, BAT941249, BAT817279, BAT942010, BAT942016, BAT942024, BAT942038, BAT941240, BAT942009, BAT942017, BAT810945, BAT813071, BAT813185, BAT813193, BAT815482, BAT815484, BAT815500, BAT817472, BAT817474, BAT817476, BAT817520, BAT817522, BAT905562, BAT905566, BAT905587, BAT905591, BAT906809, BAT932077, BAT932081, BAT932083, BAT937773, BAT937895, BAT937898, BAT939114, BAT810868, BAT811095, BAT811687, BAT813066, BAT813068, BAT815435, BAT815437, BAT815439, BAT815483, BAT815501, BAT817469, BAT817473, BAT817475, BAT817519, BAT817523, BAT905563, BAT905588, BAT906808, BAT932039, BAT932078, BAT932080, BAT932082, BAT932180, BAT937772, BAT937837, BAT937894, BAT937897, BAT939116, BAT930990, BAT930996, BAT931006, BAT931008, BAT932945, BAT930997, BAT930999, BAT931003, BAT931007, BAT931009, BAT933698, BAT813073, BAT813155, BAT813159, BAT813175, BAT813296, BAT813306, BAT813312, BAT813314, BAT813322, BAT813326, BAT813328, BAT814519, BAT814644, BAT814646, BAT814959, BAT814991, BAT816781, BAT816783, BAT816785, BAT816855, BAT816861, BAT816870, BAT816954, BAT817166, BAT817168, BAT817170, BAT817172, BAT817183, BAT817421, BAT817423, BAT817888, BAT817906, BAT818028, BAT818030, BAT818032, BAT818034, BAT902343, BAT902551, BAT902849, BAT902851, BAT903563, BAT903565, BAT903567, BAT904735, BAT904739, BAT904741, BAT904743, BAT905531, BAT905533, BAT905539, BAT905546, BAT905548, BAT905568, BAT905575, BAT905579, BAT930965, BAT931028, BAT931032, BAT931036, BAT931408, BAT931483, BAT931485, BAT931487, BAT931515, BAT931517, BAT931539, BAT931983, BAT932036, BAT932135, BAT932956, BAT932982, BAT933264, BAT933266, BAT933268, BAT936989, BAT937274, BAT937276, BAT937563, BAT937565, BAT937567, BAT937838, BAT937866, BAT937868, BAT937873, BAT937883, BAT937885, BAT940866, BAT813015, BAT813022, BAT813072, BAT813080, BAT813170, BAT813182, BAT813184, BAT813299, BAT813313, BAT813323, BAT813329, BAT813333, BAT813598, BAT814510, BAT814643, BAT816782, BAT816829, BAT816834, BAT816838, BAT816842, BAT816856, BAT816951, BAT817173, BAT817422, BAT817424, BAT817881, BAT817885, BAT817891, BAT817895, BAT818027, BAT818029, BAT902344, BAT902850, BAT902860, BAT903564, BAT903568, BAT903570, BAT904732, BAT904734, BAT904740, BAT904742, BAT904744, BAT905536, BAT905547, BAT905555, BAT905567, BAT905571, BAT905574, BAT905578, BAT930750, BAT931029, BAT931031, BAT931033, BAT931336, BAT931409, BAT931484, BAT931486, BAT931514, BAT931551, BAT932955, BAT932957, BAT932964, BAT932979, BAT932983, BAT933265, BAT933267, BAT933269, BAT936950, BAT936954, BAT936990, BAT936992, BAT937275, BAT937564, BAT937566, BAT937568, BAT937839, BAT937863, BAT937865, BAT937867, BAT937871, BAT937882, BAT937886, BAT937892, BAT806631, BAT806635, BAT806637, BAT811642, BAT811644, BAT811646, BAT814610, BAT816946, BAT817402, BAT817405, BAT817407, BAT817409, BAT817413, BAT817415, BAT817417, BAT817874, BAT818026, BAT818201, BAT818217, BAT902144, BAT902146, BAT902148, BAT933695, BAT933721, BAT933723, BAT933725, BAT933727, BAT936961, BAT936963, BAT936981, BAT936983, BAT937311, BAT937313, BAT937315, BAT937317, BAT937840, BAT937844, BAT937881, BAT941225, BAT941229, BAT941231, BAT941233, BAT806630, BAT806638, BAT806640, BAT806642, BAT811643, BAT811645, BAT811647, BAT814655, BAT817379, BAT817401, BAT817406, BAT817408, BAT817410, BAT817869, BAT818199, BAT818202, BAT902141, BAT902143, BAT902147, BAT933696, BAT933716, BAT933718, BAT933720, BAT933722, BAT933726, BAT933732, BAT936962, BAT936982, BAT937312, BAT937316, BAT937770, BAT937880, BAT941226, BAT941228, BAT811630, BAT811632, BAT812597, BAT812640, BAT812691, BAT812693, BAT812835, BAT812881, BAT813027, BAT813033, BAT813039, BAT813049, BAT813063, BAT813065, BAT813292, BAT813302, BAT813310, BAT813320, BAT814618, BAT814622, BAT814634, BAT815967, BAT816013, BAT816015, BAT816018, BAT816026, BAT816033, BAT816709, BAT816755, BAT816757, BAT816759, BAT816767, BAT816771, BAT816775, BAT816777, BAT816779, BAT817091, BAT817093, BAT817095, BAT817111, BAT817207, BAT817237, BAT817249, BAT817251, BAT817261, BAT817266, BAT817270, BAT817372, BAT817376, BAT817484, BAT817488, BAT817856, BAT817860, BAT817866, BAT817868, BAT902837, BAT904465, BAT904471, BAT906807, BAT906811, BAT931188, BAT931383, BAT931385, BAT931389, BAT931400, BAT931404, BAT931495, BAT931497, BAT931991, BAT931995, BAT932007, BAT932577, BAT932579, BAT932583, BAT932586, BAT932735, BAT932812, BAT932818, BAT932962, BAT932984, BAT933045, BAT933255, BAT933278, BAT933605, BAT933611, BAT933617, BAT933657, BAT933659, BAT934109, BAT934111, BAT936485, BAT936490, BAT936492, BAT936494, BAT937293, BAT937295, BAT937301, BAT937303, BAT937561, BAT939090, BAT939094, BAT939160, BAT939172, BAT940150, BAT942209, BAT942211, BAT942229, BAT942235, BAT942280, BAT942282, BAT942284, BAT942286, BAT942290, BAT942292, BAT942296, BAT942302, BAT942304, BAT942310, BAT942322, BAT942324, BAT811629, BAT811631, BAT812610, BAT813026, BAT813032, BAT813048, BAT813052, BAT813293, BAT813309, BAT813507, BAT814377, BAT814500, BAT814617, BAT814619, BAT814635, BAT815433, BAT815952, BAT815958, BAT815966, BAT815970, BAT815987, BAT816002, BAT816006, BAT816008, BAT816010, BAT816014, BAT816021, BAT816032, BAT816756, BAT816758, BAT816760, BAT816768, BAT816776, BAT816780, BAT816784, BAT816939, BAT817090, BAT817092, BAT817110, BAT817238, BAT817246, BAT817265, BAT817269, BAT817371, BAT817403, BAT817483, BAT817487, BAT817517, BAT817865, BAT817867, BAT902836, BAT904460, BAT904464, BAT904470, BAT904472, BAT906810, BAT930979, BAT931011, BAT931023, BAT931027, BAT931384, BAT931388, BAT931390, BAT931399, BAT931401, BAT931405, BAT931494, BAT931496, BAT931498, BAT931984, BAT931996, BAT931998, BAT932012, BAT932018, BAT932022, BAT932048, BAT932578, BAT932582, BAT932585, BAT932790, BAT932819, BAT932842, BAT932985, BAT933042, BAT933254, BAT933256, BAT933277, BAT933608, BAT933610, BAT933618, BAT933670, BAT933685, BAT934108, BAT934110, BAT934120, BAT936482, BAT936486, BAT936491, BAT937296, BAT937300, BAT937302, BAT937560, BAT937562, BAT939087, BAT939089, BAT939091, BAT939095, BAT939097, BAT942207, BAT942230, BAT942281, BAT942283, BAT942287, BAT942293, BAT942297, BAT942299, BAT942307, BAT942309, BAT942321, BAT942323, BAT942325, BAT942327, BAT806697, BAT806701, BAT806703, BAT806705, BAT806707, BAT811640, BAT811663, BAT811665, BAT812601, BAT812605, BAT812668, BAT812683, BAT813201, BAT814594, BAT814636, BAT814638, BAT814640, BAT814642, BAT815013, BAT815019, BAT815116, BAT816769, BAT816773, BAT816795, BAT816797, BAT816799, BAT816962, BAT817317, BAT817319, BAT817370, BAT817374, BAT817528, BAT817534, BAT817880, BAT818046, BAT818048, BAT901450, BAT901650, BAT901652, BAT901657, BAT901659, BAT902103, BAT902105, BAT902109, BAT902128, BAT902130, BAT902345, BAT902347, BAT902349, BAT902351, BAT902539, BAT902541, BAT902543, BAT902545, BAT902553, BAT903557, BAT904459, BAT904475, BAT904503, BAT904729, BAT904731, BAT904733, BAT905525, BAT905527, BAT905541, BAT905581, BAT930959, BAT931016, BAT931377, BAT931379, BAT931398, BAT931499, BAT931501, BAT932003, BAT932005, BAT932017, BAT932021, BAT932568, BAT932570, BAT932572, BAT932575, BAT933257, BAT933259, BAT933261, BAT933595, BAT933601, BAT933647, BAT934101, BAT934105, BAT934107, BAT934115, BAT934117, BAT934119, BAT936945, BAT937769, BAT937785, BAT937787, BAT937854, BAT937856, BAT937875, BAT937902, BAT937904, BAT937906, BAT938059, BAT939108, BAT939110, BAT939132, BAT939166, BAT939168, BAT806692, BAT806696, BAT806702, BAT806708, BAT806710, BAT811633, BAT811641, BAT811968, BAT812596, BAT812598, BAT812641, BAT812661, BAT812665, BAT812675, BAT813204, BAT814520, BAT814637, BAT814641, BAT814992, BAT815016, BAT815020, BAT816734, BAT816770, BAT816772, BAT816778, BAT816794, BAT816796, BAT816798, BAT816800, BAT816821, BAT816827, BAT817312, BAT817367, BAT817373, BAT817375, BAT817525, BAT817529, BAT817531, BAT817533, BAT817879, BAT818047, BAT818049, BAT901401, BAT901651, BAT902102, BAT902104, BAT902110, BAT902123, BAT902125, BAT902131, BAT902135, BAT902346, BAT902350, BAT902537, BAT902542, BAT902544, BAT902546, BAT902548, BAT902552, BAT903558, BAT904500, BAT904504, BAT905540, BAT905542, BAT905586, BAT906806, BAT931376, BAT931397, BAT931407, BAT931500, BAT931982, BAT932002, BAT932006, BAT932016, BAT932020, BAT932339, BAT932569, BAT932571, BAT932574, BAT932576, BAT933258, BAT933260, BAT933588, BAT933604, BAT933650, BAT934098, BAT934100, BAT934103, BAT934112, BAT934116, BAT934118, BAT936843, BAT937754, BAT937778, BAT937782, BAT937788, BAT937835, BAT937857, BAT937859, BAT937876, BAT937905, BAT938060, BAT939081, BAT939109, BAT939131, BAT939133, BAT939165, BAT939167, BAT939169, BAT939171, BAT941234, BAT941236, BAT816971, BAT816973, BAT817097, BAT817107, BAT818038, BAT818042, BAT818044, BAT906797, BAT906799, BAT906801, BAT932085, BAT932087, BAT933585, BAT937755, BAT937757, BAT937763, BAT937765, BAT939084, BAT941251, BAT941253, BAT941255, BAT816970, BAT816972, BAT816974, BAT817096, BAT817100, BAT817102, BAT817114, BAT818035, BAT818043, BAT818045, BAT906792, BAT906798, BAT906800, BAT932084, BAT932086, BAT932090, BAT932092, BAT937760, BAT937762, BAT941238, BAT941252, BAT941254, BAT941256, BAT933567, BAT933675, BAT939162, BAT941241, BAT941243, BAT941245, BAT941247, BAT937768, BAT941244, BAT941246, BAT815167, BAT815358, BAT815388, BAT815430, BAT930984, BAT931010, BAT931014, BAT941121, BAT941127, BAT815297, BAT815414, BAT815416, BAT815425, BAT815427, BAT815429, BAT930985, BAT930987, BAT931015, BAT936499, BAT940875, BAT941120, BAT941122, BAT941131, BAT813131, BAT813143, BAT815122, BAT815126, BAT815130, BAT815134, BAT815136, BAT905606, BAT905608, BAT905614, BAT905626, BAT906803, BAT906805, BAT930969, BAT930971, BAT930978, BAT937559, BAT939098, BAT939156, BAT939158, BAT813084, BAT813130, BAT813132, BAT813134, BAT813140, BAT813146, BAT813152, BAT813154, BAT815123, BAT815125, BAT815127, BAT815129, BAT815133, BAT905609, BAT905611, BAT905613, BAT905623, BAT905630, BAT906802, BAT906804, BAT930958, BAT930966, BAT930970, BAT930975, BAT930977, BAT937292, BAT937841, BAT939099, BAT939155, BAT939157, BAT812701, BAT812717, BAT813183, BAT815159, BAT815165, BAT815173, BAT815181, BAT815456, BAT815458, BAT815470, BAT816787, BAT816793, BAT817113, BAT817156, BAT817162, BAT817164, BAT817299, BAT901431, BAT901438, BAT901442, BAT901446, BAT902353, BAT902355, BAT904505, BAT906793, BAT906795, BAT906813, BAT931394, BAT931489, BAT931491, BAT931493, BAT932028, BAT932139, BAT932155, BAT932358, BAT932373, BAT932409, BAT932461, BAT932532, BAT932943, BAT932947, BAT932949, BAT932951, BAT933276, BAT933571, BAT934121, BAT934124, BAT934126, BAT936480, BAT936496, BAT936498, BAT936500, BAT937846, BAT937860, BAT937862, BAT937879, BAT939112, BAT939134, BAT942314, BAT942316, BAT942318, BAT942320, BAT812708, BAT812736, BAT815139, BAT815149, BAT815172, BAT815174, BAT815176, BAT815180, BAT815186, BAT815459, BAT815461, BAT815465, BAT815469, BAT815471, BAT816792, BAT817165, BAT817298, ...

Label field

Details supplied by the agency

Lot, code or applicability

a. GTIN 00763000187767, Serial Numbers: BAT941874, BAT941880, BAT941886, BAT941935, BAT941937, BAT941944, BAT941948, BAT941960, BAT942348, BAT941747, BAT941897, BAT941955, BAT941959, BAT937852, BAT937853, BAT937887, BAT937889, BAT937893, BAT941119, BAT941132, BAT941148, BAT941962, BAT941976, BAT941988, BAT942254, BAT937888, BAT937890, BAT941133, BAT941145, BAT941147, BAT941149, BAT941303, BAT941963, BAT941965, BAT940874, BAT941024, BAT942202, BAT942217, BAT942241, BAT942270, BAT942272, BAT942199, BAT942203, BAT942212, BAT942214, BAT942218, BAT942222, BAT942224, BAT942242, BAT942248, BAT942267, BAT942271, BAT942273, BAT942311, BAT942329, BAT939092, BAT939174, BAT939176, BAT939178, BAT941257, BAT941259, BAT941263, BAT939173, BAT939175, BAT939177, BAT940999, BAT941262, BAT942204, BAT942206, BAT942236, BAT942240, BAT939078, BAT939086, BAT939088, BAT942256, BAT942262, BAT942264, BAT942266, BAT939075, BAT939079, BAT939085, BAT942261, BAT942265, BAT817284, BAT817286, BAT817290, BAT817295, BAT901435, BAT937553, BAT937555, BAT937557, BAT817283, BAT817285, BAT817287, BAT817296, BAT901437, BAT905645, BAT937554, BAT937556, BAT817154, BAT941249, BAT817279, BAT942010, BAT942016, BAT942024, BAT942038, BAT941240, BAT942009, BAT942017, BAT810945, BAT813071, BAT813185, BAT813193, BAT815482, BAT815484, BAT815500, BAT817472, BAT817474, BAT817476, BAT817520, BAT817522, BAT905562, BAT905566, BAT905587, BAT905591, BAT906809, BAT932077, BAT932081, BAT932083, BAT937773, BAT937895, BAT937898, BAT939114, BAT810868, BAT811095, BAT811687, BAT813066, BAT813068, BAT815435, BAT815437, BAT815439, BAT815483, BAT815501, BAT817469, BAT817473, BAT817475, BAT817519, BAT817523, BAT905563, BAT905588, BAT906808, BAT932039, BAT932078, BAT932080, BAT932082, BAT932180, BAT937772, BAT937837, BAT937894, BAT937897, BAT939116, BAT930990, BAT930996, BAT931006, BAT931008, BAT932945, BAT930997, BAT930999, BAT931003, BAT931007, BAT931009, BAT933698, BAT813073, BAT813155, BAT813159, BAT813175, BAT813296, BAT813306, BAT813312, BAT813314, BAT813322, BAT813326, BAT813328, BAT814519, BAT814644, BAT814646, BAT814959, BAT814991, BAT816781, BAT816783, BAT816785, BAT816855, BAT816861, BAT816870, BAT816954, BAT817166, BAT817168, BAT817170, BAT817172, BAT817183, BAT817421, BAT817423, BAT817888, BAT817906, BAT818028, BAT818030, BAT818032, BAT818034, BAT902343, BAT902551, BAT902849, BAT902851, BAT903563, BAT903565, BAT903567, BAT904735, BAT904739, BAT904741, BAT904743, BAT905531, BAT905533, BAT905539, BAT905546, BAT905548, BAT905568, BAT905575, BAT905579, BAT930965, BAT931028, BAT931032, BAT931036, BAT931408, BAT931483, BAT931485, BAT931487, BAT931515, BAT931517, BAT931539, BAT931983, BAT932036, BAT932135, BAT932956, BAT932982, BAT933264, BAT933266, BAT933268, BAT936989, BAT937274, BAT937276, BAT937563, BAT937565, BAT937567, BAT937838, BAT937866, BAT937868, BAT937873, BAT937883, BAT937885, BAT940866, BAT813015, BAT813022, BAT813072, BAT813080, BAT813170, BAT813182, BAT813184, BAT813299, BAT813313, BAT813323, BAT813329, BAT813333, BAT813598, BAT814510, BAT814643, BAT816782, BAT816829, BAT816834, BAT816838, BAT816842, BAT816856, BAT816951, BAT817173, BAT817422, BAT817424, BAT817881, BAT817885, BAT817891, BAT817895, BAT818027, BAT818029, BAT902344, BAT902850, BAT902860, BAT903564, BAT903568, BAT903570, BAT904732, BAT904734, BAT904740, BAT904742, BAT904744, BAT905536, BAT905547, BAT905555, BAT905567, BAT905571, BAT905574, BAT905578, BAT930750, BAT931029, BAT931031, BAT931033, BAT931336, BAT931409, BAT931484, BAT931486, BAT931514, BAT931551, BAT932955, BAT932957, BAT932964, BAT932979, BAT932983, BAT933265, BAT933267, BAT933269, BAT936950, BAT936954, BAT936990, BAT936992, BAT937275, BAT937564, BAT937566, BAT937568, BAT937839, BAT937863, BAT937865, BAT937867, BAT937871, BAT937882, BAT937886, BAT937892, BAT806631, BAT806635, BAT806637, BAT811642, BAT811644, BAT811646, BAT814610, BAT816946, BAT817402, BAT817405, BAT817407, BAT817409, BAT817413, BAT817415, BAT817417, BAT817874, BAT818026, BAT818201, BAT818217, BAT902144, BAT902146, BAT902148, BAT933695, BAT933721, BAT933723, BAT933725, BAT933727, BAT936961, BAT936963, BAT936981, BAT936983, BAT937311, BAT937313, BAT937315, BAT937317, BAT937840, BAT937844, BAT937881, BAT941225, BAT941229, BAT941231, BAT941233, BAT806630, BAT806638, BAT806640, BAT806642, BAT811643, BAT811645, BAT811647, BAT814655, BAT817379, BAT817401, BAT817406, BAT817408, BAT817410, BAT817869, BAT818199, BAT818202, BAT902141, BAT902143, BAT902147, BAT933696, BAT933716, BAT933718, BAT933720, BAT933722, BAT933726, BAT933732, BAT936962, BAT936982, BAT937312, BAT937316, BAT937770, BAT937880, BAT941226, BAT941228, BAT811630, BAT811632, BAT812597, BAT812640, BAT812691, BAT812693, BAT812835, BAT812881, BAT813027, BAT813033, BAT813039, BAT813049, BAT813063, BAT813065, BAT813292, BAT813302, BAT813310, BAT813320, BAT814618, BAT814622, BAT814634, BAT815967, BAT816013, BAT816015, BAT816018, BAT816026, BAT816033, BAT816709, BAT816755, BAT816757, BAT816759, BAT816767, BAT816771, BAT816775, BAT816777, BAT816779, BAT817091, BAT817093, BAT817095, BAT817111, BAT817207, BAT817237, BAT817249, BAT817251, BAT817261, BAT817266, BAT817270, BAT817372, BAT817376, BAT817484, BAT817488, BAT817856, BAT817860, BAT817866, BAT817868, BAT902837, BAT904465, BAT904471, BAT906807, BAT906811, BAT931188, BAT931383, BAT931385, BAT931389, BAT931400, BAT931404, BAT931495, BAT931497, BAT931991, BAT931995, BAT932007, BAT932577, BAT932579, BAT932583, BAT932586, BAT932735, BAT932812, BAT932818, BAT932962, BAT932984, BAT933045, BAT933255, BAT933278, BAT933605, BAT933611, BAT933617, BAT933657, BAT933659, BAT934109, BAT934111, BAT936485, BAT936490, BAT936492, BAT936494, BAT937293, BAT937295, BAT937301, BAT937303, BAT937561, BAT939090, BAT939094, BAT939160, BAT939172, BAT940150, BAT942209, BAT942211, BAT942229, BAT942235, BAT942280, BAT942282, BAT942284, BAT942286, BAT942290, BAT942292, BAT942296, BAT942302, BAT942304, BAT942310, BAT942322, BAT942324, BAT811629, BAT811631, BAT812610, BAT813026, BAT813032, BAT813048, BAT813052, BAT813293, BAT813309, BAT813507, BAT814377, BAT814500, BAT814617, BAT814619, BAT814635, BAT815433, BAT815952, BAT815958, BAT815966, BAT815970, BAT815987, BAT816002, BAT816006, BAT816008, BAT816010, BAT816014, BAT816021, BAT816032, BAT816756, BAT816758, BAT816760, BAT816768, BAT816776, BAT816780, BAT816784, BAT816939, BAT817090, BAT817092, BAT817110, BAT817238, BAT817246, BAT817265, BAT817269, BAT817371, BAT817403, BAT817483, BAT817487, BAT817517, BAT817865, BAT817867, BAT902836, BAT904460, BAT904464, BAT904470, BAT904472, BAT906810, BAT930979, BAT931011, BAT931023, BAT931027, BAT931384, BAT931388, BAT931390, BAT931399, BAT931401, BAT931405, BAT931494, BAT931496, BAT931498, BAT931984, BAT931996, BAT931998, BAT932012, BAT932018, BAT932022, BAT932048, BAT932578, BAT932582, BAT932585, BAT932790, BAT932819, BAT932842, BAT932985, BAT933042, BAT933254, BAT933256, BAT933277, BAT933608, BAT933610, BAT933618, BAT933670, BAT933685, BAT934108, BAT934110, BAT934120, BAT936482, BAT936486, BAT936491, BAT937296, BAT937300, BAT937302, BAT937560, BAT937562, BAT939087, BAT939089, BAT939091, BAT939095, BAT939097, BAT942207, BAT942230, BAT942281, BAT942283, BAT942287, BAT942293, BAT942297, BAT942299, BAT942307, BAT942309, BAT942321, BAT942323, BAT942325, BAT942327, BAT806697, BAT806701, BAT806703, BAT806705, BAT806707, BAT811640, BAT811663, BAT811665, BAT812601, BAT812605, BAT812668, BAT812683, BAT813201, BAT814594, BAT814636, BAT814638, BAT814640, BAT814642, BAT815013, BAT815019, BAT815116, BAT816769, BAT816773, BAT816795, BAT816797, BAT816799, BAT816962, BAT817317, BAT817319, BAT817370, BAT817374, BAT817528, BAT817534, BAT817880, BAT818046, BAT818048, BAT901450, BAT901650, BAT901652, BAT901657, BAT901659, BAT902103, BAT902105, BAT902109, BAT902128, BAT902130, BAT902345, BAT902347, BAT902349, BAT902351, BAT902539, BAT902541, BAT902543, BAT902545, BAT902553, BAT903557, BAT904459, BAT904475, BAT904503, BAT904729, BAT904731, BAT904733, BAT905525, BAT905527, BAT905541, BAT905581, BAT930959, BAT931016, BAT931377, BAT931379, BAT931398, BAT931499, BAT931501, BAT932003, BAT932005, BAT932017, BAT932021, BAT932568, BAT932570, BAT932572, BAT932575, BAT933257, BAT933259, BAT933261, BAT933595, BAT933601, BAT933647, BAT934101, BAT934105, BAT934107, BAT934115, BAT934117, BAT934119, BAT936945, BAT937769, BAT937785, BAT937787, BAT937854, BAT937856, BAT937875, BAT937902, BAT937904, BAT937906, BAT938059, BAT939108, BAT939110, BAT939132, BAT939166, BAT939168, BAT806692, BAT806696, BAT806702, BAT806708, BAT806710, BAT811633, BAT811641, BAT811968, BAT812596, BAT812598, BAT812641, BAT812661, BAT812665, BAT812675, BAT813204, BAT814520, BAT814637, BAT814641, BAT814992, BAT815016, BAT815020, BAT816734, BAT816770, BAT816772, BAT816778, BAT816794, BAT816796, BAT816798, BAT816800, BAT816821, BAT816827, BAT817312, BAT817367, BAT817373, BAT817375, BAT817525, BAT817529, BAT817531, BAT817533, BAT817879, BAT818047, BAT818049, BAT901401, BAT901651, BAT902102, BAT902104, BAT902110, BAT902123, BAT902125, BAT902131, BAT902135, BAT902346, BAT902350, BAT902537, BAT902542, BAT902544, BAT902546, BAT902548, BAT902552, BAT903558, BAT904500, BAT904504, BAT905540, BAT905542, BAT905586, BAT906806, BAT931376, BAT931397, BAT931407, BAT931500, BAT931982, BAT932002, BAT932006, BAT932016, BAT932020, BAT932339, BAT932569, BAT932571, BAT932574, BAT932576, BAT933258, BAT933260, BAT933588, BAT933604, BAT933650, BAT934098, BAT934100, BAT934103, BAT934112, BAT934116, BAT934118, BAT936843, BAT937754, BAT937778, BAT937782, BAT937788, BAT937835, BAT937857, BAT937859, BAT937876, BAT937905, BAT938060, BAT939081, BAT939109, BAT939131, BAT939133, BAT939165, BAT939167, BAT939169, BAT939171, BAT941234, BAT941236, BAT816971, BAT816973, BAT817097, BAT817107, BAT818038, BAT818042, BAT818044, BAT906797, BAT906799, BAT906801, BAT932085, BAT932087, BAT933585, BAT937755, BAT937757, BAT937763, BAT937765, BAT939084, BAT941251, BAT941253, BAT941255, BAT816970, BAT816972, BAT816974, BAT817096, BAT817100, BAT817102, BAT817114, BAT818035, BAT818043, BAT818045, BAT906792, BAT906798, BAT906800, BAT932084, BAT932086, BAT932090, BAT932092, BAT937760, BAT937762, BAT941238, BAT941252, BAT941254, BAT941256, BAT933567, BAT933675, BAT939162, BAT941241, BAT941243, BAT941245, BAT941247, BAT937768, BAT941244, BAT941246, BAT815167, BAT815358, BAT815388, BAT815430, BAT930984, BAT931010, BAT931014, BAT941121, BAT941127, BAT815297, BAT815414, BAT815416, BAT815425, BAT815427, BAT815429, BAT930985, BAT930987, BAT931015, BAT936499, BAT940875, BAT941120, BAT941122, BAT941131, BAT813131, BAT813143, BAT815122, BAT815126, BAT815130, BAT815134, BAT815136, BAT905606, BAT905608, BAT905614, BAT905626, BAT906803, BAT906805, BAT930969, BAT930971, BAT930978, BAT937559, BAT939098, BAT939156, BAT939158, BAT813084, BAT813130, BAT813132, BAT813134, BAT813140, BAT813146, BAT813152, BAT813154, BAT815123, BAT815125, BAT815127, BAT815129, BAT815133, BAT905609, BAT905611, BAT905613, BAT905623, BAT905630, BAT906802, BAT906804, BAT930958, BAT930966, BAT930970, BAT930975, BAT930977, BAT937292, BAT937841, BAT939099, BAT939155, BAT939157, BAT812701, BAT812717, BAT813183, BAT815159, BAT815165, BAT815173, BAT815181, BAT815456, BAT815458, BAT815470, BAT816787, BAT816793, BAT817113, BAT817156, BAT817162, BAT817164, BAT817299, BAT901431, BAT901438, BAT901442, BAT901446, BAT902353, BAT902355, BAT904505, BAT906793, BAT906795, BAT906813, BAT931394, BAT931489, BAT931491, BAT931493, BAT932028, BAT932139, BAT932155, BAT932358, BAT932373, BAT932409, BAT932461, BAT932532, BAT932943, BAT932947, BAT932949, BAT932951, BAT933276, BAT933571, BAT934121, BAT934124, BAT934126, BAT936480, BAT936496, BAT936498, BAT936500, BAT937846, BAT937860, BAT937862, BAT937879, BAT939112, BAT939134, BAT942314, BAT942316, BAT942318, BAT942320, BAT812708, BAT812736, BAT815139, BAT815149, BAT815172, BAT815174, BAT815176, BAT815180, BAT815186, BAT815459, BAT815461, BAT815465, BAT815469, BAT815471, BAT816792, BAT817165, BAT817298, ...

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, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece, Netherlands, Sweden, Norway, Denmark, Estonia, Lebanon, Croatia, Spain, Austria, United Arab Emirates, Luxembourg, Canada, Korea, Republic Of, Israel, Qatar, India, Australia, New Zealand, Taiwan, Malaysia, Hong Kong, Singapore, Latvia, Saudi Arabia, Slovakia, North Macedonia, Finland, Turkey, Armenia, Colombia, Kazakhstan, Kuwait, Serbia, Bahrain, Egypt, Pakistan, and Ukraine.

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: Aug 24, 2022
Recall initiation date: Jun 28, 2022
Center classification date: Aug 18, 2022

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