FDA has not published a risk classification for this recall yet.
- Recall #:
- 85397
- Lot/product code:
- GTIN 00888707000017, Serial Numbers: HW26899, HW27283, HW27893, HW28873, HW28999, HW29422, HW29488, HW29722, HW30166, HW30170 GTIN 00888707002639, Serial Numbers: HW29525, HW30015, HW30297, HW30477, HW31174, HW31179, HW31181, HW31246, HW31247, HW31250, HW31253, HW31257, HW31266, HW31268, hw31280, HW31281, hw31282, HW31283, HW31313, HW31385, HW31401, HW31497, HW31525, HW31526, HW31530, HW31531, HW31562, HW31567, HW31596, HW31597, HW31601, HW31602, HW31608, HW31609, HW31612, HW31624, HW31626, HW31634, HW31640, HW31641, HW31642, HW31643, HW31644, HW31645, HW31646, HW31647, HW31648, HW31649, HW31651, HW31652, HW31653, HW31655, HW31656, HW31657, HW31658, HW31659, HW31660, HW31661, HW31662, HW31663, HW31665, HW31666, HW31667, HW31668, HW31669, HW31670, HW31671, HW31672, HW31674, HW31675, HW31676, HW31677, HW31678, HW31679, HW31680, HW31681, HW31682, HW31687, HW31688, HW31689, HW31690, HW31691, HW31692, HW31693, HW31695, HW31696, HW31701, HW31705, HW31706, HW31707, HW31708, HW31709, HW31710, HW31711, HW31712, HW31713, HW31714, HW31716, HW31717, HW31719, HW31720, HW31721, HW31722, HW31723, HW31724, HW31725, HW31726, HW31728, HW31730, HW31732, HW31734, HW31736, HW31737, HW31738, HW31739, HW31740, HW31741, HW31742, HW31743, HW31744, HW31745, HW31746, HW31747, HW31748, HW31751, HW31752, HW31753, HW31754, HW31756, HW31757, HW31758, HW31760, HW31761, HW31762, HW31763, HW31764, HW31765, HW31766, HW31767, HW31768, HW31769, HW31770, HW31771, HW31772, HW31773, HW31774, HW31775, HW31776, HW31781, HW31782, HW31783, HW31784, HW31785, HW31786, HW31787, HW31788, HW31789, HW31790, HW31792, HW31793, HW31794, HW31796, HW31797, HW31798, HW31799, HW31800, HW31802, HW31803, HW31804, HW31805, HW31807, HW31816, HW31829, HW31841, HW31848, HW31850, HW31853, HW31854, HW31857, HW31861, HW31862, HW31864, HW31865, HW31866, HW31867, HW31868, HW31869, HW31870, HW31871, HW31878, HW31879, HW31880, HW31881, HW31882, HW31884, HW31885, HW31886, HW31887, HW31888, HW31889, HW31890, HW31894, HW31895, HW31896, HW31897, HW31898, HW31899, HW31900, HW31902, HW31904, HW31905, HW31906, HW31907, HW31910, HW31911, HW31913, HW31914, HW31916, HW31917, HW31918, HW31922, HW31923, HW31933, HW31935, HW31936, HW31938, HW31942, HW31943, HW31945, HW31946, HW31948, HW31949, HW31950, HW31951, HW31952, HW31953, HW31954, HW31956, HW31957, HW31959, HW31960, HW31961, HW31962, HW31963, HW31964, HW31965, HW31966, HW31967, HW31968, HW31969, HW31970, HW31971, HW31972, HW31974, HW31975, HW31977, HW31978, HW31980, HW31990, HW32003, HW32004, HW32005, HW32007, HW32016, HW32019, HW32020, HW32031, HW32033, HW32037, HW32041, HW32044, HW32045, HW32047, HW32048, HW32049, HW32051, HW32052, HW32054, HW32058, HW32059, HW32060, HW32061, HW32063, HW32066, HW32067, HW32069, HW32070, HW32072, HW32073, HW32074, HW32075, HW32076, HW32077, HW32078, HW32079, HW32080, HW32082, HW32083, HW32084, HW32087, HW32088, HW32089, HW32090, HW32091, HW32092, HW32093, HW32095, HW32096, HW32097, HW32098, HW32099, HW32100, HW32101, HW32104, HW32105, HW32106, HW32107, HW32110, HW32111, HW32114, HW32115, HW32117, HW32119, HW32120, HW32122, HW32126, HW32127, HW32128, HW32129, HW32130, HW32133, HW32134, HW32136, HW32137, HW32139, HW32140, HW32142, HW32145, HW32146, HW32148, HW32150, HW32151, HW32154, HW32155, HW32157, HW32158, HW32168, HW32169, HW32171, HW32173, HW32174, HW32176, HW32177, HW32178, HW32184, HW32185, HW32187, HW32188, HW32191, HW32196, HW32203, HW32208, HW32213, HW32225, HW32227, HW32233, HW32235, HW32237, HW32247, HW32249, HW32251, HW32252, HW32254, HW32262, HW32266, HW32267, HW32271, HW32272, HW32274, HW32275, HW32276, HW32277, HW32278, HW32280, HW32283, HW32284, HW32287, HW32288, HW32291, HW32293, HW32295, HW32296, HW32298, HW32299, HW32300, HW32302, HW32303, HW32304, HW32305, HW32306, HW32307, HW32308, HW32310, HW32311, HW32312, HW32313, HW32314, HW32316, HW32317, HW32318, HW32319, HW32320, HW32321, HW32322, HW32323, HW32324, HW32325, HW32326, HW32327, HW32328, HW32329, HW32330, HW32331, HW32332, HW32333, HW32334, HW32337, HW32338, HW32339, HW32340, HW32341, HW32343, HW32344, HW32345, HW32346, HW32348, HW32349, HW32350, HW32351, HW32352, HW32354, HW32355, HW32358, HW32359, HW32360, HW32361, HW32362, HW32363, HW32364, HW32365, HW32366, HW32367, HW32368, HW32370, HW32371, HW32372, HW32374, HW32375, HW32376, HW32377, HW32378, HW32379, HW32380, HW32381, HW32382, HW32383, HW32384, HW32387, HW32389, HW32390, HW32391, HW32392, HW32395, HW32396, HW32397, HW32398, HW32399, HW32401, HW32402, HW32403, HW32404, HW32405, HW32406, HW32409, HW32411, HW32412, HW32413, HW32414, HW32417, HW32418, HW32421, HW32422, HW32424, HW32425, HW32428, HW32429, HW32430, HW32431, HW32432, HW32433, HW32434, HW32436, HW32438, HW32439, HW32440, HW32441, HW32442, HW32443, HW32444, HW32446, HW32447, HW32448, HW32449, HW32450, HW32451, HW32452, HW32453, HW32454, HW32455, HW32456, HW32460, HW32461, HW32462, HW32463, HW32466, HW32467, HW32469, HW32475, HW32476, HW32477, HW32478, HW32480, HW32481, HW32482, HW32484, HW32485, HW32486, H… (truncated, 23638 characters total — see the official FDA record for the full value)
- Recalling firm:
- Heartware, Inc.