Recall archive / FDA device enforcement

Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) ... — FDA record Z-1110-2022

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 Mar 30, 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: Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are distributed with unique Catalog / Model Numbers: IFU00358, IFU00375, IFU00376, GR00526, IFU00520, IFU00526, IFU00593, IFU00614, M017475C001
Reason: Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
Classification: Class II
Recalling firm: Medtronic Inc
Quantity: 21,118 pieces of product literature
Agency-reported status: Ongoing
Source record identifier: Z-1110-2022

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	Device Model numbers affected: 1104: GTIN 00888707002028, Serial Numbers: HW28848, HW29011, HW29154, HW29199, HW29211, HW29212, HW29219, HW29229, HW29246, HW29248, HW29249, HW29252, HW29265, HW29266, HW29268, HW29271, HW29273, HW29274, HW29276, HW29279, HW29282, HW29283, HW29284, HW29285, HW29286, HW29287, HW29290, HW29293, HW29302, HW29309, HW29310, HW29329, HW29333, HW29387, HW29426, HW29465, HW29472, HW29485, HW29502, HW29503, HW29522, HW29526, HW29532, HW29533, HW29534, HW29535, HW29536, HW29538, HW29539, HW29540, HW29541, HW29542, HW29543, HW29546, HW29547, HW29548, HW29549, HW29551, HW29552, HW29562, HW29567, HW29579, HW29583, HW29586, HW29587, HW29588, HW29589, HW29590, HW29592, HW29593, HW29594, HW29595, HW29600, HW29602, HW29603, HW29604, HW29612, HW29629, HW29635, HW29650, HW29660, HW29661, HW29664, HW29665, HW29666, HW29667, HW29668, HW29669, HW29670, HW29671, HW29672, HW29673, HW29674, HW29675, HW29676, HW29685, HW29686, HW29687, HW29700, HW29701, HW29702, HW29717, HW29727, HW29741, HW29754, HW29755, HW29764, HW29776, HW29780, HW29781, HW29782, HW29784, HW29786, HW29787, HW29788, HW29790, HW29791, HW29798, HW29815, HW29820, HW29825, HW29832, HW29836, HW29850, HW29866, HW29867, HW29873, HW29877, HW29887, HW29894, HW29895, HW29896, HW29900, HW29903, HW29904, HW29909, HW29911, HW29915, HW29922, HW29923, HW29927, HW29928, HW29932, HW29949, HW29965, HW29976, HW29983, HW29990, HW29995, HW30038, HW30039, HW30040, HW30079, HW30080, HW30081, HW30082, HW30083, HW30084, HW30085, HW30086, HW30087, HW30088, HW30089, HW30102, HW30103, HW30104, HW30105, HW30106, HW30107, HW30108, HW30109, HW30110, HW30111, HW30112, HW30113, HW30115, HW30116, HW30117, HW30118, HW30147, HW30148, HW30149, HW30150, HW30151, HW30152, HW30153, HW30154, HW30155, HW30156, HW30157, HW30178, HW30193, HW30194, HW30195, HW30196, HW30197, HW30198, HW30199, HW30200, HW30201, HW30202, HW30204, HW30205, HW30207, HW30208, HW30209, HW30210, HW30211, HW30212, HW30213, HW30214, HW30224, HW30225, HW30226, HW30227, HW30231, HW30267, HW30319, HW30320, HW30342, HW30358, HW30360, HW30363, HW30364, HW30365, HW30366, HW30367, HW30369, HW30370, HW30372, HW30376, HW30378, HW30380, HW30382, HW30383, HW30384, HW30385, HW30387, HW30390, HW30392, HW30393, HW30397, HW30398, HW30399, HW30400, HW30402, HW30404, HW30406, HW30407, HW30408, HW30409, HW30410, HW30430, HW30449, HW30455, HW30461, HW30462, HW30463, HW30471, HW30472, HW30473, HW30475, HW30483, HW30484, HW30485, HW30486, HW30491, HW30494, HW30498, HW30595, HW30596, HW30597, HW30598, HW30599, HW30600, HW30601, HW30602, HW30603, HW30604, HW30606, HW30607, HW30608, HW30651, HW30652, HW30654, HW30656, HW30768, HW30769, HW30770, HW30771, HW30808, HW30809, HW30810, HW30811, HW30813, HW30814, HW30815, HW30816, HW30818, HW30820, HW30821, HW30822, HW30823, HW30824, HW30825, HW30829, HW30830, HW30863, HW30864, HW30865, HW30866, HW30867, HW30868, HW30869, HW30870, HW30871, HW30953, HW30954, HW30955, HW30956, HW30957, HW30958, HW30959, HW30960, HW30961, HW30962, HW30963, HW30964, HW30966, HW30967, HW30968, HW30970, HW30971, HW30972, HW30973, HW30974, HW30976, HW31015, HW31020, HW31072, HW31076, HW31087, HW31101, HW31103, HW31104, HW31105, HW31107, HW31111, HW31113, HW31114, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31226, HW31228, HW31232, HW31235, HW31242, HW31244, HW31249, HW31251, HW31254, HW31255, HW31258, HW31260, HW31261, HW31262, HW31267, HW31383, HW31386, HW31387, HW31388, HW31390, HW31398, HW31399, HW31402, HW31409, HW31410, HW31411, HW31412, HW31414, HW31445, HW31446, HW31447, HW31448, HW31449, HW31451, HW31452, HW31453, HW31454, HW31455, HW31456, HW31457, HW31458, HW31541, HW31543, HW31544, HW31545, HW31547, HW31548, HW31549, HW31550, HW31552, HW31559, HW31564, HW31571, HW31573, HW31578, HW31579, HW31686, HW31694, HW31697, HW31731, HW31749, HW31750, HW31777, HW31778, HW31810, HW31819, HW31830, HW31831, HW31832, HW31834, HW31835, HW31836, HW31838, HW31839, HW31840, HW31842, HW31843, HW31844, HW31845, HW31846, HW31847, HW31849, HW31855, HW31858, HW31876, HW31883, HW31944, HW31947, HW31979, HW31981, HW31986, HW31987, HW31988, HW31989, HW31991, HW32068, HW32116, HW32121, HW32141, HW32143, HW32156, HW32159, HW32161, HW32162, HW32164, HW32167, HW32172, HW32179, HW32189, HW32190, HW32192, HW32193, HW32194, HW32197, HW32199, HW32201, HW32204, HW32206, HW32209, HW32210, HW32214, HW32215, HW32216, HW32218, HW32220, HW32222, HW32223, HW32224, HW32228, HW32229, HW32230, HW32231, HW32248, HW32258, HW32259, HW32260, HW32261, HW32273, HW32279, HW32281, HW32285, HW32286, HW32290, HW32292, HW32315, HW32335, HW32357, HW32386, HW32393, HW32400, HW32419, HW32423, HW32426, HW32427, HW32457, HW32458, HW32459, HW32464, HW32465, HW32468, HW32470, HW32471, HW32472, HW32479, HW32499, HW32504, HW32508, HW32509, HW32510, HW32511, HW32516, HW32534, HW34001, HW34002, HW34025, HW34034, HW34035, HW34036, HW34037, HW34038, HW34040, HW34041, HW34042, HW34043, HW34044, HW34045, HW34046, HW34047, HW34048, HW34051, HW34066, HW34096, HW34100, HW34104, HW34106, HW34109, HW34110, HW34111, HW34113, HW34117, HW34121, HW34126, HW34151, HW34169, HW34179, HW34181, HW34186, HW34187, HW34192, HW34193, HW34196, HW34197, HW34202, HW34204, HW34205, HW34207, HW34209, HW34211, HW34226, HW34317, HW34319, HW34326, HW34328, HW34329, HW34330, HW34331, HW34336, HW34342, HW34344, HW34347, HW34368, HW34369, HW34371, HW34372, HW34373, HW34375, HW34376, HW34377, HW34378, HW34379, HW34425, HW34427, HW34428, HW34429, HW34432, HW34446, HW34495, HW34519, HW34520, HW34521, HW34522, HW34523, HW34546, HW34547, HW34550, HW34551, HW34555, HW34556, HW34588, HW34590, HW34596, HW34603, HW34605, HW34609, HW34610, HW34643, HW34673, HW34752, HW34768, HW34805, HW34806, HW34808, HW34810, HW34824, HW34840, HW34842, HW34845, HW34866, HW34868, HW34877, HW34902, HW34903, HW34904, HW34908, HW34910, HW34913, HW34914, HW34923, HW34924, HW34925, HW34928, HW34933, HW34934, HW34938, HW34939, HW34944, HW34946, HW34947, HW34948, HW34949, HW34957, HW34979, HW34990, HW34997, HW35012, HW35032, HW35099, HW35122, HW35123, HW35124, HW35125, HW35128, HW35131, HW35133, HW35134, HW35136, HW35138, HW35141, HW35143, HW35161, HW35189, HW35191, HW35204, HW35205, HW35209, HW35211, HW35212, HW35213, HW35214, HW35215, HW35220, HW35284, HW35305, HW35317, HW35319, HW35321, HW35324, HW35325, HW35326, HW35332, HW35334, HW35337, HW35339, HW35340, HW35341, HW35357, HW35360, HW35361, HW35367, HW35385, HW35464, HW35477, HW35478, HW35479, HW35480, HW35481, HW35482, HW35483, HW35487, HW35488, HW35489, HW35492, HW35493, HW35494, HW35495, HW35499, HW35500, HW35501, HW35502, HW35504, HW35506, HW35508, HW35534, HW35535, HW35539, HW35540, HW35541, HW35542, HW35543, HW35545, HW35548, HW35563, HW35577, HW35578, HW35580, HW35582, HW35583, HW35584, HW35586, HW35587, HW35588, HW35624, HW35625, HW35626, HW35627, HW35628, HW35629, HW35630, HW35631, HW35632, HW35633, HW35634, HW35635, HW35636, HW35637, HW35639, HW35641, HW35644, HW35646, HW35647, HW35668, HW35669, HW35670, HW35671, HW35673, HW35674, HW35676, HW35677, HW35678, HW35680, HW35681, HW35682, HW35683, HW35684, HW35686, HW35687, HW35688, HW35689, HW35690, HW35691, HW35692, HW35693, HW35695, HW35696, HW35697, HW35698, HW35701, HW35702, HW35703, HW35704, HW35705, HW35707, HW35708, HW35730, HW35731, HW29208R01, HW29209R01, HW29225R01, HW29226R01, HW29241R01, HW29242R01, HW29245R01, HW29247R01; GTIN 00888707003063, Serial Numbers: HW41903, HW41911, HW41924, HW41925, HW41926, HW41927, HW41928, HW41929, HW41950, HW41953, HW42004, HW42006, HW42007, HW42008, HW42018, HW42019, HW42089, HW42158, HW42160, HW42161, HW42219, HW42230, HW42235, HW42237, HW42238, HW42650, HW42651, HW42678, HW42720, HW42724, HW42790, HW42793, HW42797, HW42829, HW42831, HW43009; GTIN 00888707003070, Serial Numbers: HW41892, HW41894, HW41895, HW41897, HW41899, HW41900, HW41901, HW41932, HW41934, HW41936, HW41937, HW41938, HW41939, HW41940, HW41941, HW41971, HW41972, HW41973, HW41974, HW41975, HW41977, HW41986, HW41991, HW41993, HW41994, HW41997, HW42000, HW42001, HW42002, HW42005, HW42009, HW42021, HW42022, HW42026, HW42099, HW42101, HW42103, HW42104, HW42110, HW42111, HW42114, HW42116, HW42148, HW42153, HW42155, HW42157, HW42223, HW42225, HW42228, HW42229, HW42232, HW42233, HW42252, HW42291, HW42307, HW42326, HW42328, HW42329, HW42330, HW42331, HW42332, HW42333, HW42500, HW42666, HW42915; GTIN 00888707003100, Serial Numbers: HW41961, HW41962, HW41964, HW41965, HW41966, HW41967, HW41968, HW42313, HW42660, HW42663, HW42671, HW42672, HW42901; GTIN 00888707003117, Serial Numbers: HW41955, HW41957, HW41958, HW41959, HW41960, HW42023, HW42024, HW42025, HW42061, HW42091, HW42130, HW42292, HW42335, HW42337, HW42339, HW42647, HW42665; GTIN 00888707003209, Serial Numbers: HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990; GTIN 00888707003254, Serial Numbers: HW41943, HW41944, HW42213; GTIN 00888707005968, Serial Numbers: HW35801, HW35802, HW35803, HW35804, HW35805, HW35806, HW35807, HW35808, HW35809, HW35810, HW35811, HW35812, HW35813, HW35814, HW35815, HW35816, HW35817, HW35818, HW35820, HW35847, HW35848, HW35850, HW35851, HW35852, HW35853, HW35854, HW35855, HW35856, HW35857, HW35858, HW35859, HW35860, HW35861, HW35862, HW35863, HW35864, HW35867, HW35870, HW35875, HW35923, HW35924, HW35927, HW35929, HW35931, HW35935, HW35936, HW35937, HW35938, HW35939, HW35966, HW35967, HW35968, HW35969, HW35970, HW35971, HW35972, HW35975, HW35976, HW35978, HW35988, HW35989, HW35990, HW35991, HW35993, HW35994, HW35995, HW35996, HW35997; GTIN 00888707006330, Serial Numbers: HW31419, HW31699, HW31733, HW32505, HW35393, HW35396, HW35562, HW35571, HW35726, HW35749, HW35766, HW35769, HW35784, HW35829, HW35872, HW36005, HW36006, HW36007, HW36008, HW36009, HW36010, HW36013, HW36018, HW36019, HW36020, HW36021, HW36069, HW36070, HW36071, HW36131, HW36132, HW36138, HW36174, HW36175, HW36176, HW36177, HW36178, HW36179, HW36180, HW36184, HW36185, HW36186, HW36192, HW36193, HW36194, HW36195, HW36197, HW36198, HW36199, HW36200, HW36201, HW36224, HW36225, HW36226, HW36227, HW36228, HW36229, HW36230, HW36231, HW36232, HW36233, HW36248, HW36251, HW36252, HW36253, HW36254, HW36255, HW36256, HW36258, HW36259, HW36260, HW36276, HW36298, HW36299, HW36300, HW36303, HW36305, HW36307, HW36309, HW36310, HW36313, HW36314, HW36316, HW36317, HW36318, HW36319, HW36320, HW36321, HW36323, HW36324, HW36325, HW36326, HW36328, HW36332, HW36333, HW36334, HW36335, HW36354, HW36355, HW36356, HW36357, HW36358, HW36359, HW36360, HW36361, HW36362, HW36363, HW36396, HW36397, HW36398, HW36399, HW36400, HW36401, HW36403, HW36404, HW36405, HW36406, HW36407, HW36408, HW36409, HW36410, HW36411, HW36412, HW36419, HW36428, HW36429, HW36430, HW36432, HW36433, HW36434, HW36435, HW36436, HW36437, HW36438, HW36500, HW36501, HW36502, HW36503, HW36504, HW36505, HW36506, HW36507, HW36508, HW36509, HW36510, HW36511, HW36513, HW36514, HW36515, HW36530, HW36553, HW36554, HW36555, HW36556, HW36557, HW36559, HW36560, HW36561, HW36562, HW36563, HW36564, HW36595, HW36596, HW36597, HW36598, HW36599, HW36600, HW36601, HW36602, HW36603, HW36624, HW36625, HW36626, HW36628, HW36630, HW36631, HW36633, HW36636, HW36637, HW36654, HW36655, HW36659, HW36660, HW36662, HW36664, HW36669, HW36670, HW36671, HW36672, HW36673, HW36677, HW36678, HW36680, HW36681, HW36683, HW36685, HW36702, HW36703, HW36704, HW36705, HW36708, HW36709, HW36710, HW36711, HW36712, HW36713, HW36718, HW36719, HW36720, HW36722, HW36723, HW36724, HW36725, HW36726, HW36727, HW36728, HW36750, HW36752, HW36753, HW36754, HW36755, HW36785, HW36786, HW36788, HW36789, HW36812, HW36813, HW36815, HW36816, HW36817, HW36818, HW36823, HW36827, HW36829, HW36830, HW36831, HW36832, HW36833, HW36834, HW36835, HW36836, HW36837, HW36839, HW36840, HW36853, HW36854, HW36855, HW36877, HW36881, HW36882, HW36883, HW36891, HW36897, HW36898, HW36899, HW36900, HW36901, HW36902, HW36919, HW...

Label field

Details supplied by the agency

Lot, code or applicability

Device Model numbers affected: 1104: GTIN 00888707002028, Serial Numbers: HW28848, HW29011, HW29154, HW29199, HW29211, HW29212, HW29219, HW29229, HW29246, HW29248, HW29249, HW29252, HW29265, HW29266, HW29268, HW29271, HW29273, HW29274, HW29276, HW29279, HW29282, HW29283, HW29284, HW29285, HW29286, HW29287, HW29290, HW29293, HW29302, HW29309, HW29310, HW29329, HW29333, HW29387, HW29426, HW29465, HW29472, HW29485, HW29502, HW29503, HW29522, HW29526, HW29532, HW29533, HW29534, HW29535, HW29536, HW29538, HW29539, HW29540, HW29541, HW29542, HW29543, HW29546, HW29547, HW29548, HW29549, HW29551, HW29552, HW29562, HW29567, HW29579, HW29583, HW29586, HW29587, HW29588, HW29589, HW29590, HW29592, HW29593, HW29594, HW29595, HW29600, HW29602, HW29603, HW29604, HW29612, HW29629, HW29635, HW29650, HW29660, HW29661, HW29664, HW29665, HW29666, HW29667, HW29668, HW29669, HW29670, HW29671, HW29672, HW29673, HW29674, HW29675, HW29676, HW29685, HW29686, HW29687, HW29700, HW29701, HW29702, HW29717, HW29727, HW29741, HW29754, HW29755, HW29764, HW29776, HW29780, HW29781, HW29782, HW29784, HW29786, HW29787, HW29788, HW29790, HW29791, HW29798, HW29815, HW29820, HW29825, HW29832, HW29836, HW29850, HW29866, HW29867, HW29873, HW29877, HW29887, HW29894, HW29895, HW29896, HW29900, HW29903, HW29904, HW29909, HW29911, HW29915, HW29922, HW29923, HW29927, HW29928, HW29932, HW29949, HW29965, HW29976, HW29983, HW29990, HW29995, HW30038, HW30039, HW30040, HW30079, HW30080, HW30081, HW30082, HW30083, HW30084, HW30085, HW30086, HW30087, HW30088, HW30089, HW30102, HW30103, HW30104, HW30105, HW30106, HW30107, HW30108, HW30109, HW30110, HW30111, HW30112, HW30113, HW30115, HW30116, HW30117, HW30118, HW30147, HW30148, HW30149, HW30150, HW30151, HW30152, HW30153, HW30154, HW30155, HW30156, HW30157, HW30178, HW30193, HW30194, HW30195, HW30196, HW30197, HW30198, HW30199, HW30200, HW30201, HW30202, HW30204, HW30205, HW30207, HW30208, HW30209, HW30210, HW30211, HW30212, HW30213, HW30214, HW30224, HW30225, HW30226, HW30227, HW30231, HW30267, HW30319, HW30320, HW30342, HW30358, HW30360, HW30363, HW30364, HW30365, HW30366, HW30367, HW30369, HW30370, HW30372, HW30376, HW30378, HW30380, HW30382, HW30383, HW30384, HW30385, HW30387, HW30390, HW30392, HW30393, HW30397, HW30398, HW30399, HW30400, HW30402, HW30404, HW30406, HW30407, HW30408, HW30409, HW30410, HW30430, HW30449, HW30455, HW30461, HW30462, HW30463, HW30471, HW30472, HW30473, HW30475, HW30483, HW30484, HW30485, HW30486, HW30491, HW30494, HW30498, HW30595, HW30596, HW30597, HW30598, HW30599, HW30600, HW30601, HW30602, HW30603, HW30604, HW30606, HW30607, HW30608, HW30651, HW30652, HW30654, HW30656, HW30768, HW30769, HW30770, HW30771, HW30808, HW30809, HW30810, HW30811, HW30813, HW30814, HW30815, HW30816, HW30818, HW30820, HW30821, HW30822, HW30823, HW30824, HW30825, HW30829, HW30830, HW30863, HW30864, HW30865, HW30866, HW30867, HW30868, HW30869, HW30870, HW30871, HW30953, HW30954, HW30955, HW30956, HW30957, HW30958, HW30959, HW30960, HW30961, HW30962, HW30963, HW30964, HW30966, HW30967, HW30968, HW30970, HW30971, HW30972, HW30973, HW30974, HW30976, HW31015, HW31020, HW31072, HW31076, HW31087, HW31101, HW31103, HW31104, HW31105, HW31107, HW31111, HW31113, HW31114, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31226, HW31228, HW31232, HW31235, HW31242, HW31244, HW31249, HW31251, HW31254, HW31255, HW31258, HW31260, HW31261, HW31262, HW31267, HW31383, HW31386, HW31387, HW31388, HW31390, HW31398, HW31399, HW31402, HW31409, HW31410, HW31411, HW31412, HW31414, HW31445, HW31446, HW31447, HW31448, HW31449, HW31451, HW31452, HW31453, HW31454, HW31455, HW31456, HW31457, HW31458, HW31541, HW31543, HW31544, HW31545, HW31547, HW31548, HW31549, HW31550, HW31552, HW31559, HW31564, HW31571, HW31573, HW31578, HW31579, HW31686, HW31694, HW31697, HW31731, HW31749, HW31750, HW31777, HW31778, HW31810, HW31819, HW31830, HW31831, HW31832, HW31834, HW31835, HW31836, HW31838, HW31839, HW31840, HW31842, HW31843, HW31844, HW31845, HW31846, HW31847, HW31849, HW31855, HW31858, HW31876, HW31883, HW31944, HW31947, HW31979, HW31981, HW31986, HW31987, HW31988, HW31989, HW31991, HW32068, HW32116, HW32121, HW32141, HW32143, HW32156, HW32159, HW32161, HW32162, HW32164, HW32167, HW32172, HW32179, HW32189, HW32190, HW32192, HW32193, HW32194, HW32197, HW32199, HW32201, HW32204, HW32206, HW32209, HW32210, HW32214, HW32215, HW32216, HW32218, HW32220, HW32222, HW32223, HW32224, HW32228, HW32229, HW32230, HW32231, HW32248, HW32258, HW32259, HW32260, HW32261, HW32273, HW32279, HW32281, HW32285, HW32286, HW32290, HW32292, HW32315, HW32335, HW32357, HW32386, HW32393, HW32400, HW32419, HW32423, HW32426, HW32427, HW32457, HW32458, HW32459, HW32464, HW32465, HW32468, HW32470, HW32471, HW32472, HW32479, HW32499, HW32504, HW32508, HW32509, HW32510, HW32511, HW32516, HW32534, HW34001, HW34002, HW34025, HW34034, HW34035, HW34036, HW34037, HW34038, HW34040, HW34041, HW34042, HW34043, HW34044, HW34045, HW34046, HW34047, HW34048, HW34051, HW34066, HW34096, HW34100, HW34104, HW34106, HW34109, HW34110, HW34111, HW34113, HW34117, HW34121, HW34126, HW34151, HW34169, HW34179, HW34181, HW34186, HW34187, HW34192, HW34193, HW34196, HW34197, HW34202, HW34204, HW34205, HW34207, HW34209, HW34211, HW34226, HW34317, HW34319, HW34326, HW34328, HW34329, HW34330, HW34331, HW34336, HW34342, HW34344, HW34347, HW34368, HW34369, HW34371, HW34372, HW34373, HW34375, HW34376, HW34377, HW34378, HW34379, HW34425, HW34427, HW34428, HW34429, HW34432, HW34446, HW34495, HW34519, HW34520, HW34521, HW34522, HW34523, HW34546, HW34547, HW34550, HW34551, HW34555, HW34556, HW34588, HW34590, HW34596, HW34603, HW34605, HW34609, HW34610, HW34643, HW34673, HW34752, HW34768, HW34805, HW34806, HW34808, HW34810, HW34824, HW34840, HW34842, HW34845, HW34866, HW34868, HW34877, HW34902, HW34903, HW34904, HW34908, HW34910, HW34913, HW34914, HW34923, HW34924, HW34925, HW34928, HW34933, HW34934, HW34938, HW34939, HW34944, HW34946, HW34947, HW34948, HW34949, HW34957, HW34979, HW34990, HW34997, HW35012, HW35032, HW35099, HW35122, HW35123, HW35124, HW35125, HW35128, HW35131, HW35133, HW35134, HW35136, HW35138, HW35141, HW35143, HW35161, HW35189, HW35191, HW35204, HW35205, HW35209, HW35211, HW35212, HW35213, HW35214, HW35215, HW35220, HW35284, HW35305, HW35317, HW35319, HW35321, HW35324, HW35325, HW35326, HW35332, HW35334, HW35337, HW35339, HW35340, HW35341, HW35357, HW35360, HW35361, HW35367, HW35385, HW35464, HW35477, HW35478, HW35479, HW35480, HW35481, HW35482, HW35483, HW35487, HW35488, HW35489, HW35492, HW35493, HW35494, HW35495, HW35499, HW35500, HW35501, HW35502, HW35504, HW35506, HW35508, HW35534, HW35535, HW35539, HW35540, HW35541, HW35542, HW35543, HW35545, HW35548, HW35563, HW35577, HW35578, HW35580, HW35582, HW35583, HW35584, HW35586, HW35587, HW35588, HW35624, HW35625, HW35626, HW35627, HW35628, HW35629, HW35630, HW35631, HW35632, HW35633, HW35634, HW35635, HW35636, HW35637, HW35639, HW35641, HW35644, HW35646, HW35647, HW35668, HW35669, HW35670, HW35671, HW35673, HW35674, HW35676, HW35677, HW35678, HW35680, HW35681, HW35682, HW35683, HW35684, HW35686, HW35687, HW35688, HW35689, HW35690, HW35691, HW35692, HW35693, HW35695, HW35696, HW35697, HW35698, HW35701, HW35702, HW35703, HW35704, HW35705, HW35707, HW35708, HW35730, HW35731, HW29208R01, HW29209R01, HW29225R01, HW29226R01, HW29241R01, HW29242R01, HW29245R01, HW29247R01; GTIN 00888707003063, Serial Numbers: HW41903, HW41911, HW41924, HW41925, HW41926, HW41927, HW41928, HW41929, HW41950, HW41953, HW42004, HW42006, HW42007, HW42008, HW42018, HW42019, HW42089, HW42158, HW42160, HW42161, HW42219, HW42230, HW42235, HW42237, HW42238, HW42650, HW42651, HW42678, HW42720, HW42724, HW42790, HW42793, HW42797, HW42829, HW42831, HW43009; GTIN 00888707003070, Serial Numbers: HW41892, HW41894, HW41895, HW41897, HW41899, HW41900, HW41901, HW41932, HW41934, HW41936, HW41937, HW41938, HW41939, HW41940, HW41941, HW41971, HW41972, HW41973, HW41974, HW41975, HW41977, HW41986, HW41991, HW41993, HW41994, HW41997, HW42000, HW42001, HW42002, HW42005, HW42009, HW42021, HW42022, HW42026, HW42099, HW42101, HW42103, HW42104, HW42110, HW42111, HW42114, HW42116, HW42148, HW42153, HW42155, HW42157, HW42223, HW42225, HW42228, HW42229, HW42232, HW42233, HW42252, HW42291, HW42307, HW42326, HW42328, HW42329, HW42330, HW42331, HW42332, HW42333, HW42500, HW42666, HW42915; GTIN 00888707003100, Serial Numbers: HW41961, HW41962, HW41964, HW41965, HW41966, HW41967, HW41968, HW42313, HW42660, HW42663, HW42671, HW42672, HW42901; GTIN 00888707003117, Serial Numbers: HW41955, HW41957, HW41958, HW41959, HW41960, HW42023, HW42024, HW42025, HW42061, HW42091, HW42130, HW42292, HW42335, HW42337, HW42339, HW42647, HW42665; GTIN 00888707003209, Serial Numbers: HW41915, HW41916, HW41918, HW41919, HW41945, HW41946, HW41947, HW41948, HW41978, HW41979, HW41981, HW41982, HW41983, HW41984, HW41988, HW41990; GTIN 00888707003254, Serial Numbers: HW41943, HW41944, HW42213; GTIN 00888707005968, Serial Numbers: HW35801, HW35802, HW35803, HW35804, HW35805, HW35806, HW35807, HW35808, HW35809, HW35810, HW35811, HW35812, HW35813, HW35814, HW35815, HW35816, HW35817, HW35818, HW35820, HW35847, HW35848, HW35850, HW35851, HW35852, HW35853, HW35854, HW35855, HW35856, HW35857, HW35858, HW35859, HW35860, HW35861, HW35862, HW35863, HW35864, HW35867, HW35870, HW35875, HW35923, HW35924, HW35927, HW35929, HW35931, HW35935, HW35936, HW35937, HW35938, HW35939, HW35966, HW35967, HW35968, HW35969, HW35970, HW35971, HW35972, HW35975, HW35976, HW35978, HW35988, HW35989, HW35990, HW35991, HW35993, HW35994, HW35995, HW35996, HW35997; GTIN 00888707006330, Serial Numbers: HW31419, HW31699, HW31733, HW32505, HW35393, HW35396, HW35562, HW35571, HW35726, HW35749, HW35766, HW35769, HW35784, HW35829, HW35872, HW36005, HW36006, HW36007, HW36008, HW36009, HW36010, HW36013, HW36018, HW36019, HW36020, HW36021, HW36069, HW36070, HW36071, HW36131, HW36132, HW36138, HW36174, HW36175, HW36176, HW36177, HW36178, HW36179, HW36180, HW36184, HW36185, HW36186, HW36192, HW36193, HW36194, HW36195, HW36197, HW36198, HW36199, HW36200, HW36201, HW36224, HW36225, HW36226, HW36227, HW36228, HW36229, HW36230, HW36231, HW36232, HW36233, HW36248, HW36251, HW36252, HW36253, HW36254, HW36255, HW36256, HW36258, HW36259, HW36260, HW36276, HW36298, HW36299, HW36300, HW36303, HW36305, HW36307, HW36309, HW36310, HW36313, HW36314, HW36316, HW36317, HW36318, HW36319, HW36320, HW36321, HW36323, HW36324, HW36325, HW36326, HW36328, HW36332, HW36333, HW36334, HW36335, HW36354, HW36355, HW36356, HW36357, HW36358, HW36359, HW36360, HW36361, HW36362, HW36363, HW36396, HW36397, HW36398, HW36399, HW36400, HW36401, HW36403, HW36404, HW36405, HW36406, HW36407, HW36408, HW36409, HW36410, HW36411, HW36412, HW36419, HW36428, HW36429, HW36430, HW36432, HW36433, HW36434, HW36435, HW36436, HW36437, HW36438, HW36500, HW36501, HW36502, HW36503, HW36504, HW36505, HW36506, HW36507, HW36508, HW36509, HW36510, HW36511, HW36513, HW36514, HW36515, HW36530, HW36553, HW36554, HW36555, HW36556, HW36557, HW36559, HW36560, HW36561, HW36562, HW36563, HW36564, HW36595, HW36596, HW36597, HW36598, HW36599, HW36600, HW36601, HW36602, HW36603, HW36624, HW36625, HW36626, HW36628, HW36630, HW36631, HW36633, HW36636, HW36637, HW36654, HW36655, HW36659, HW36660, HW36662, HW36664, HW36669, HW36670, HW36671, HW36672, HW36673, HW36677, HW36678, HW36680, HW36681, HW36683, HW36685, HW36702, HW36703, HW36704, HW36705, HW36708, HW36709, HW36710, HW36711, HW36712, HW36713, HW36718, HW36719, HW36720, HW36722, HW36723, HW36724, HW36725, HW36726, HW36727, HW36728, HW36750, HW36752, HW36753, HW36754, HW36755, HW36785, HW36786, HW36788, HW36789, HW36812, HW36813, HW36815, HW36816, HW36817, HW36818, HW36823, HW36827, HW36829, HW36830, HW36831, HW36832, HW36833, HW36834, HW36835, HW36836, HW36837, HW36839, HW36840, HW36853, HW36854, HW36855, HW36877, HW36881, HW36882, HW36883, HW36891, HW36897, HW36898, HW36899, HW36900, HW36901, HW36902, HW36919, HW...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom

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: May 25, 2022
Recall initiation date: Mar 30, 2022
Center classification date: May 17, 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