FDA has not published a risk classification for this recall yet.
- Recall #:
- 86924
- Lot/product code:
- a. Model Number 1103:
GTIN 00888707003261, Serial Numbers HW40002, HW40004, HW40006, HW40009, HW40017, HW40025, HW40045, HW40046, HW40048, HW40049, HW40051, HW40054, HW40061, HW40067, HW40068, HW40073, HW40074, HW40075, HW40079, HW40085, HW40087, HW40089, HW40090, HW40094, HW40097, HW40099, HW40100, HW40109, HW40112, HW40120, HW40121, HW40122, HW40138, HW40139, HW40143, HW40145, HW40147, HW40149, HW40152, HW40153, HW40154, HW40157, HW40166, HW40168, HW40169, HW40176, HW40177, HW40178, HW40186, HW40189, HW40190, HW40192, HW40197, HW40199, HW40200, HW40201, HW40202, HW40206, HW40209, HW40210, HW40211, HW40212, HW40223, HW40226, HW40230, HW40232, HW40238, HW40240, HW40245, HW40247, HW40259, HW40262, HW40263, HW40270, HW40271, HW40272, HW40273, HW40281, HW40283, HW40288, HW40292, HW40293, HW40294, HW40295, HW40298, HW40299, HW40301, HW40302, HW40303, HW40305, HW40307, HW40317, HW40322, HW40324, HW40326, HW40329, HW40334, HW40337, HW40340, HW40359, HW40371, HW40373, HW40376, HW40381, HW40384, HW40390, HW40392, HW40395, HW40397, HW40399, HW40402, HW40405, HW40433, HW40436, HW40440, HW40443, HW40444, HW40445, HW40448, HW40453, HW40455, HW40460, HW40466, HW40481, HW40482, HW40483, HW40488, HW40489, HW40490, HW40491, HW40499, HW40501, HW40503, HW40504, HW40509, HW40510, HW40512, HW40515, HW40517, HW40518, HW40520, HW40523, HW40524, HW40527, HW40528, HW40529, HW40530, HW40533, HW40534, HW40537, HW40546, HW40558, HW40567, HW40568, HW40569, HW40572, HW40576, HW40583, HW40585, HW40590, HW40592, HW40593, HW40595, HW40605, HW40606, HW40616, HW40620, HW40621, HW40622, HW40627, HW40631, HW40633, HW40635, HW40636, HW40644, HW40672, HW40678, HW40682, HW40683, HW40684, HW40687, HW40690, HW40694, HW40696, HW40700, HW40703, HW40705, HW40708, HW40710, HW40715, HW40717, HW40718, HW40719, HW40723, HW40728, HW40732, HW40737, HW40739, HW40744, HW40745, HW40746, HW40749, HW40750, HW40753, HW40755, HW40757, HW40759, HW40762, HW40766, HW40767, HW40769, HW40772, HW40776, HW40778, HW40780, HW40783, HW40800, HW40801, HW40805, HW40807, HW40810, HW40813, HW40815, HW40819, HW40821, HW40829, HW40831, HW40832, HW40834, HW40838, HW40841, HW40857, HW40861, HW40862, HW40863, HW40865, HW40868, HW40870, HW40874, HW40875, HW40876, HW40882, HW40883, HW40884, HW40891, HW40894, HW40902, HW40903, HW40905, HW40908, HW40913, HW40916, HW40917, HW40918, HW40922, HW40924, HW40925, HW40927, HW40928, HW40930, HW40935, HW40939, HW40941, HW40944, HW40948, HW40962, HW40967, HW40968, HW40976, HW40977, HW40986, HW40987, HW40988, HW40991, HW40995, HW40998, HW41001, HW41005, HW41007, HW41008, HW41012, HW41017, HW41022, HW41032, HW41035, HW41038, HW41054, HW41057, HW41058, HW41059, HW41060, HW41064, HW41066, HW41069, HW41072, HW41073, HW41076, HW41077, HW41081, HW41084, HW41092, HW41097, HW41098, HW41100, HW41104, HW41105, HW41107, HW41111, HW41115, HW41124, HW41131, HW41137, HW41138, HW41146, HW41148, HW41154, HW41157, HW41158, HW41165, HW41167, HW41172, HW41176, HW41179, HW41180, HW41182, HW41185, HW41186, HW41188, HW41194, HW41195, HW41207, HW41208, HW41225, HW41227, HW41228, HW41229, HW41232, HW41234, HW41237, HW41238, HW41240, HW41247, HW41248, HW41250, HW41275, HW41276, HW41278, HW41280, HW41283, HW41288, HW41289, HW41291, HW41295, HW41298, HW41300, HW41310, HW41318, HW41321, HW41327, HW41330, HW41331, HW41334, HW41338, HW41341, HW41345, HW41351, HW41360, HW41361, HW41381, HW41382, HW41385, HW41388, HW41389, HW41393, HW41394, HW41400, HW41404, HW41410, HW41412, HW41419, HW41421, HW41423, HW41424, HW41425, HW41427, HW41431, HW41432, HW41435, HW41438, HW41441, HW41443, HW41444, HW41451, HW41453, HW41456, HW41457, HW41459, HW41461, HW41463, HW41464, HW41468, HW41470, HW41478, HW41479, HW41480, HW41481, HW41489, HW41492, HW41497, HW41503, HW41504, HW41508, HW41509, HW41517, HW41519, HW41524, HW41525, HW41529, HW41531, HW41537, HW41548, HW41551, HW41556, HW41573, HW41577, HW41578, HW41584, HW41585, HW41586, HW41588, HW41589, HW41590, HW41591, HW41594, HW41596, HW41598, HW41603, HW41605, HW41608, HW41614, HW41616, HW41618, HW41626, HW41627, HW41630, HW41631, HW41636, HW41642, HW41650, HW41657, HW41659, HW41662, HW41664, HW41666, HW41668, HW41678, HW41679, HW41681, HW41688, HW41692, HW41702, HW41703, HW41707, HW41708, HW41712, HW41719, HW41729, HW41731, HW41733, HW41735, HW41747, HW41748, HW41749, HW41756, HW41772, HW41787, HW41795, HW41797, HW41807, HW41812, HW41814, HW41816, HW41820, HW41821, HW41822, HW41823, HW41836, HW41841, HW41844, HW41861, HW41866, HW41867, HW41873, HW41880, HW42121, HW42125, HW42129, HW42134, HW42142, HW42144, HW42210, HW42220, HW42242, HW42260, HW42277, HW42279, HW42281, HW42283, HW42323, HW42324, HW42343, HW42389, HW42727, HW42736, HW42768, HW42804, HW42810, HW42819, HW42770.
GTIN 00888707002639, Serial Numbers: HW29766, HW29809, HW29831, HW29874, HW29946, HW30015, HW31099, HW31169, HW31174, HW31177, HW31181, HW31189, HW31215, HW31246, HW31278, HW31279, HW31281, HW31289, HW31302, HW31313, HW31347, HW31349, HW31361, HW31363, HW31369, HW3138… (truncated, 177937 characters total — see the official FDA record for the full value)
- Recalling firm:
- Heartware, Inc.