Recall archive / FDA device enforcement

Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Contro... — FDA record Z-2164-2025

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 Jun 23, 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: Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller, Packaged, IN; Product Code: 0042-0000-IN. 6. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 7. Impella Controller, Japan, Loaner; Product Code: 0042-0000-JP-L. 8. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 9. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L. 10. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 11. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 12. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 13. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 14. Impella Optical Controller, EU, Loaner; Product Code: 0042-0010-EU-L. 15. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 16. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 17. Impella Optical Controller, UK, Loaner; Product Code: 0042-0010-UK-L. 18. Impella Optical Controller, Packaged, US; Product Code: 0042-0010-US. 19. Impella Optical Controller, US, Loaner; Product Code: 0042-0010-US-L. 20. Optical, AIC, Impella Connect, Packaged, AU; Product Code: 0042-0040-AU. 21. Optical AIC w/Impella Connect, Packaged, CA; Product Code: 0042-0040-CA. 22. AIC w/Remote Link, Packaged, Cln Trl, US; Product Code: 0042-0040-CT-L. 23. Optical AIC w/Impella Connect, Packaged, EU; Product Code: 0042-0040-EU. 24. Optical AIC w/Impella Connect, EU, Loaner; Product Code: 0042-0040-EU-L. 25. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP. 26. Optical AIC w/Impella Connect, Pkgd, JP; Product Code: 0042-0040-JP-L. 27. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 28. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US. 29. Optical AIC Impella Connect, US, Loaner; Product Code: 0042-0040-US-L. 30. Dbl optical, AIC Impella Connect, Phg US; Product Code: 1000201. 31. AIC w/Impella Connect for ECP; Product Code: 1000432.
Reason: A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected
Classification: Class I
Recalling firm: Abiomed, Inc.
Quantity: 11,031 units
Agency-reported status: Ongoing
Source record identifier: Z-2164-2025

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	1. Product Code: 0042-0000-AU; GTIN Number: 813502010886; Serial Numbers: IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6526, IC6527, IC6528, IC6529, IC6530, IC6531, IC5622, IC5677, IC5752, IC5836, IC5341, IC5521, IC5522, IC5523, IC5524, IC5525, IC5237, IC5216, IC5217, IC5236, IC5238. 2. Product Code: 0042-0000-CA; GTIN Number: 813502011272; Serial Numbers: IC9416, IC9414, IC9415, IC9413, IC8283, IC7695, IC7716, IC7694, IC6633, IC6634, IC6635, IC6636, IC6082, IC6083, IC5821, IC5824, IC5680, IC5034, IC5050, IC4944, IC4945, IC3802, IC3803, IC3661, IC3662, IC2686, IC2687, IC2369, IC2370, IC2033, IC2035, IC2032, IC2034, IC1911, IC1912, IC1913, IC1790, IC1791, IC1715, IC1769, IC1664, IC1665, IC1595, IC1598, IC1572, IC1543, IC1544, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN Number: 813502011289; Serial Numbers: IC7809, IC7717, IC7718, IC7719, IC7720, IC7721, IC7748, IC7674, IC7675, IC7686, IC7687, IC7688, IC7689, IC7690, IC7691, IC7692, IC7693, IC7653, IC7654, IC7655, IC7666, IC7667, IC7646, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7613, IC7614, IC7615, IC7421, IC7576, IC7577, IC7578, IC7579, IC7580, IC7581, IC7582, IC7583, IC7584, IC7455, IC7452, IC7453, IC7454, IC7378, IC7388, IC7389, IC7390, IC7392, IC7393, IC7394, IC7407, IC7395, IC7406, IC7263, IC7264, IC7265, IC7286, IC7258, IC7259, IC7260, IC7261, IC7262, IC7087, IC7092, IC7093, IC7094, IC7095, IC7096, IC7097, IC7098, IC7099, IC7100, IC7075, IC7076, IC7077, IC7078, IC6843, IC6844, IC6845, IC6876, IC6877, IC6878, IC6879, IC6880, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6810, IC6812, IC6813, IC6814, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6710, IC6711, IC6712, IC6713, IC6714, IC6715, IC6716, IC6717, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6708, IC6709, IC6587, IC6588, IC6589, IC6590, IC6591, IC6592, IC6593, IC6594, IC6595, IC6577, IC6578, IC6579, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6510, IC6449, IC6469, IC6474, IC6487, IC6488, IC6489, IC6437, IC6439, IC6440, IC6441, IC6443, IC6431, IC6432, IC6435, IC6436, IC6434, IC6370, IC6371, IC6372, IC6373, IC6374, IC6375, IC6386, IC6387, IC6270, IC6331, IC6205, IC6214, IC6216, IC6293, IC6294, IC6272, IC6273, IC6274, IC6275, IC6223, IC6224, IC6225, IC6236, IC6164, IC6165, IC6147, IC6148, IC6149, IC6150, IC6151, IC6078, IC6081, IC6079, IC6080, IC6064, IC6076, IC5817, IC5818, IC5774, IC5775, IC5777, IC5779, IC5781, IC5780, IC5754, IC5755, IC5756, IC5757, IC5611, IC5714, IC5715, IC5716, IC5717, IC5722, IC5681, IC5682, IC5683, IC5684, IC5685, IC5686, IC5688, IC5687, IC5559, IC5560, IC5558, IC5517, IC5518, IC5519, IC5520, IC5495, IC5496, IC5487, IC5488, IC5489, IC5490, IC5491, IC5492, IC5493, IC5494, IC5476, IC5477, IC5357, IC5465, IC5466, IC5467, IC5460, IC5461, IC5462, IC5463, IC5464, IC5440, IC5441, IC5442, IC5443, IC5433, IC5434, IC5435, IC5436, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5251, IC5252, IC5193, IC5194, IC5195, IC5210, IC5212, IC5169, IC5171, IC5173, IC5174, IC5175, IC5176, IC5177, IC5178, IC5051, IC5053, IC5075, IC5086, IC5087, IC5088, IC5046, IC5047, IC5048, IC5049, IC5057, IC5055, IC4973, IC5007, IC5008, IC5009, IC4984, IC4986, IC4987, IC4988, IC4850, IC4928, IC4929, IC4930, IC4931, IC4932, IC4933, IC4934, IC4911, IC4912, IC4913, IC4914, IC4915, IC4916, IC4917, IC4845, IC4846, IC4833, IC4834, IC4835, IC4836, IC4837, IC4839, IC4840, IC4823, IC4824, IC4815, IC4816, IC4817, IC4818, IC4819, IC4820, IC4821, IC4822, IC4790, IC4791, IC4792, IC4793, IC4794, IC4795, IC4796, IC4797, IC4781, IC4748, IC4757, IC4758, IC4759, IC4760, IC4761, IC4762, IC4763, IC4723, IC4724, IC4733, IC4734, IC4735, IC4736, IC4737, IC4738, IC4725, IC4727, IC4728, IC4729, IC4677, IC4678, IC4679, IC4680, IC4681, IC4682, IC4645, IC4646, IC4647, IC4648, IC4649, IC4656, IC4657, IC4658, IC4585, IC4630, IC4631, IC4632, IC4633, IC4634, IC4635, IC4636, IC4623, IC4624, IC4626, IC4627, IC4628, IC4629, IC4609, IC4610, IC4611, IC4612, IC4613, IC4614, IC4594, IC4595, IC4597, IC4598, IC4557, IC4565, IC4566, IC4567, IC4568, IC4569, IC4559, IC4560, IC4561, IC4562, IC4563, IC4564, IC4500, IC4501, IC4502, IC4503, IC4505, IC4506, IC4507, IC4508, IC4464, IC4465, IC4466, IC4467, IC4468, IC4469, IC4470, IC4471, IC4442, IC4443, IC4444, IC4445, IC4446, IC4365, IC4366, IC4367, IC4370, IC4371, IC4356, IC4357, IC4358, IC4359, IC4360, IC4361, IC4362, IC4363, IC4322, IC4323, IC4324, IC4325, IC4326, IC4328, IC4329, IC4251, IC4252, IC4253, IC4254, IC4255, IC4256, IC4257, IC4258, IC4235, IC4236, IC4237, IC4238, IC4241, IC4242, IC4240, IC4233, IC4227, IC4228, IC4229, IC4230, IC4231, IC4232, IC4234, IC4217, IC4218, IC4207, IC4208, IC4209, IC4210, IC4211, IC4212, IC4175, IC4146, IC4147, IC4148, IC4149, IC4150, IC4151, IC4152, IC4153, IC4128, IC4129, IC4096, IC4097, IC4098, IC4099, IC4100, IC4081, IC4083, IC4068, IC4069, IC4054, IC4055, IC4036, IC4037, IC4033, IC4034, IC4035, IC4002, IC4006, IC4012, IC4013, IC4014, IC4015, IC3885, IC3886, IC3887, IC3888, IC3889, IC3891, IC3884, IC3890, IC3868, IC3869, IC3870, IC3871, IC3872, IC3874, IC3875, IC3873, IC3859, IC3861, IC3862, IC3863, IC3864, IC3866, IC3867, IC3860, IC3828, IC3829, IC3830, IC3831, IC3833, IC3834, IC3832, IC3815, IC3816, IC3817, IC3818, IC3812, IC3813, IC3814, IC3777, IC3778, IC3780, IC3781, IC3782, IC3783, IC3776, IC3779, IC3717, IC3724, IC3718, IC3719, IC3720, IC3701, IC3703, IC3706, IC3707, IC3708, IC3709, IC3704, IC3705, IC3696, IC3697, IC3698, IC3699, IC3700, IC3702, IC3657, IC3667, IC3668, IC3669, IC3670, IC3671, IC3672, IC3673, IC3663, IC3664, IC3665, IC3666, IC3492, IC3493, IC3495, IC3656, IC3658, IC3659, IC3494, IC3660, IC3477, IC3485, IC3486, IC3487, IC3488, IC3489, IC3491, IC3490, IC3484, IC3466, IC3467, IC3468, IC3469, IC3470, IC3471, IC3472, IC3458, IC3459, IC3460, IC3461, IC3462, IC3463, IC3313, IC3319, IC3323, IC3329, IC3330, IC3331, IC3332, IC3327, IC3328, IC3314, IC3315, IC3316, IC3317, IC3318, IC3321, IC3322, IC3324, IC3304, IC3305, IC3306, IC3307, IC3308, IC3309, IC3310, IC3311, IC3296, IC3297, IC3298, IC3299, IC3300, IC3303, IC3301, IC3302, IC3286, IC3287, IC3288, IC3289, IC3290, IC3291, IC3292, IC3184, IC3178, IC3179, IC3180, IC3181, IC3182, IC3183, IC3142, IC3143, IC3144, IC3145, IC3146, IC3147, IC3148, IC3149, IC3127, IC3128, IC3129, IC3130, IC3133, IC3134, IC3131, IC3132, IC3095, IC3096, IC3097, IC3098, IC3100, IC3101, IC3099, IC3102, IC3067, IC3068, IC3069, IC3070, IC3048, IC3049, IC3051, IC3052, IC3053, IC3054, IC3050, IC3015, IC3016, IC3017, IC3018, IC3019, IC3020, IC3021, IC3022, IC2996, IC2997, IC2984, IC2985, IC2987, IC2988, IC2989, IC2960, IC2961, IC2962, IC2963, IC2964, IC2873, IC2874, IC2875, IC2876, IC2877, IC2878, IC2855, IC2856, IC2858, IC2859, IC2862, IC2860, IC2861, IC2835, IC2836, IC2837, IC2838, IC2823, IC2824, IC2825, IC2826, IC2828, IC2829, IC2830, IC2827, IC2763, IC2766, IC2767, IC2765, IC2755, IC2756, IC2757, IC2758, IC2753, IC2754, IC2751, IC2752, IC2676, IC2677, IC2678, IC2679, IC2708, IC2709, IC2710, IC2712, IC2668, IC2669, IC2670, IC2652, IC2653, IC2654, IC2655, IC2656, IC2657, IC2658, IC2659, IC2606, IC2607, IC2609, IC2610, IC2559, IC2491, IC2512, IC2534, IC2560, IC2471, IC2481, IC2483, IC2484, IC2485, IC2486, IC2490, IC2494, IC2475, IC2476, IC2477, IC2478, IC2479, IC2469, IC2470, IC2472, IC2473, IC2474, IC2556, IC2557, IC2441, IC2442, IC2443, IC2444, IC2411, IC2412, IC2413, IC2414, IC2380, IC2325, IC2326, IC2327, IC2329, IC2330, IC2331, IC2332, IC2266, IC2267, IC2268, IC2239, IC2240, IC2241, IC2242, IC2243, IC2244, IC2245, IC2231, IC2232, IC2233, IC2234, IC2235, IC2236, IC2220, IC2221, IC2222, IC2219, IC2204, IC2205, IC2206, IC2207, IC2171, IC2172, IC2173, IC2174, IC2178, IC2179, IC2175, IC2095, IC2096, IC2097, IC2098, IC2099, IC2100, IC2101, IC2102, IC2021, IC2038, IC2039, IC2040, IC2005, IC2006, IC1971, IC1972, IC1973, IC1974, IC1975, IC1976, IC1977, IC1978, IC1901, IC1902, IC1903, IC1904, IC1905, IC1907, IC1908, IC1775, IC1780, IC1881, IC1886, IC1870, IC1872, IC1874, IC1871, IC1876, IC1821, IC1822, IC1823, IC1824, IC1825, IC1826, IC1761, IC1763, IC1764, IC1765, IC1766, IC1767, IC1768, IC1720, IC1721, IC1722, IC1723, IC1726, IC1727, IC1724, IC1725, IC1699, IC1700, IC1677, IC1678, IC1684, IC1685, IC1676, IC1653, IC1584, IC1585, IC1587, IC1588, IC1590, IC1591, IC1592, IC1593, IC1594, IC1586, IC1578, IC1579, IC1580, IC1577, IC1546, IC1547, IC1548, IC1549, IC1522, IC1523, IC1524, IC1525, IC1488, IC1490, IC1413, IC1415, IC1411, IC1416, IC1395, IC1396, IC1397, IC1398, IC1393, IC1381, IC1383, IC1384, IC1385, IC1386, IC1347, IC1349, IC1350, IC1340, IC1341, IC1343, IC1344, IC1345, IC1301, IC1302, IC1304, IC1305, IC1284, IC1288, IC1283, IC1285, IC1276, IC1277, IC1278, IC1280, IC1275, IC1265, IC1216, IC1217. 4. Product Code: 0042-0000-EU-L; GTIN Number: 813502011289; Serial Numbers: IC7810, IC6065, IC4910, IC4901, IC4891, IC4892, IC4875, IC4876, IC4879, IC4880, IC4881, IC4874, IC4877, IC4878, IC4867, IC4868, IC4869, IC4870, IC4871, IC4872, IC4873, IC4866, IC4855, IC4847, IC4848, IC4849, IC4851, IC4852, IC4853, IC4838, IC4622, IC4625, IC4364, IC4239, IC4032, IC3827, IC3320, IC2986, IC2857, IC2176, IC1906, IC1762, IC1520, IC1521, IC1487, IC1399, IC1303, IC1011. 5. Product Code: 0042-0000-IN; GTIN Number: 813502011418; Serial Numbers: IC7410, IC7411, IC7408, IC7409, IC7079, IC7080, IC6475, IC6476, IC6477, IC6478, IC6139, IC6252, IC6253, IC6254. 6. Product Code: 0042-0000-JP; GTIN Number: 813502010428; Serial Numbers: IC8276, IC8277, IC8278, IC8279, IC8280, IC8281, IC8282, IC8082, IC8083, IC8084, IC8078, IC8079, IC8080, IC8081, IC8047, IC8048, IC8049, IC8050, IC8051, IC8052, IC8053, IC8054, IC8055, IC8076, IC8077, IC8085, IC7981, IC7982, IC7983, IC7984, IC7985, IC8046, IC7933, IC7934, IC7935, IC7976, IC7977, IC7978, IC7979, IC7980, IC7928, IC7929, IC7902, IC7903, IC7904, IC7905, IC7926, IC7927, IC7899, IC7900, IC7901, IC7852, IC7853, IC7854, IC7855, IC7896, IC7897, IC7898, IC7851, IC7812, IC7813, IC7814, IC7815, IC7846, IC7808, IC7811, IC7784, IC7785, IC7806, IC7779, IC7780, IC7781, IC7782, IC7783, IC7746, IC7747, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7672, IC7673, IC7593, IC7594, IC7595, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7450, IC7451, IC7433, IC7434, IC7435, IC7439, IC7440, IC7412, IC7413, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7383, IC7384, IC7385, IC7386, IC7387, IC7291, IC7293, IC7294, IC7295, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC7068, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6662, IC6642, IC6650, IC6651, IC6652, IC6653, IC6654, IC6656, IC6657, IC6658, IC6659, IC6660, IC6661, IC6519, IC6605, IC6606, IC6607, IC6610, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6533, IC6429, IC6430, IC6452, IC6490, IC6491, IC6492, IC6442, IC6451, IC6466, IC6467, IC6468, IC6405, IC6406, IC6407, IC6388, IC6389, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6202, IC6203, IC6204, IC6210, IC6211, IC6212, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6091, IC6046, IC6047, IC6048, IC6049, IC5929, IC5930, IC5935, IC5936, IC5937, IC5938, IC5928, IC5864, IC5865, IC5866, IC5867, IC5868, IC5819, IC5820, IC5860, IC5861, IC5862, IC5863, IC5727, IC5728, IC5729, IC5731, IC5732, IC5733, IC5734, IC5735, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5505, IC5506, IC5507, IC5510, IC5511, IC5512, IC5515, IC5516, IC5478, IC5447, IC5444, IC5445, IC5259, IC5260, IC5261, IC5241, IC5243, IC5245, IC5027, IC4732....

Label field

Details supplied by the agency

Lot, code or applicability

1. Product Code: 0042-0000-AU; GTIN Number: 813502010886; Serial Numbers: IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6526, IC6527, IC6528, IC6529, IC6530, IC6531, IC5622, IC5677, IC5752, IC5836, IC5341, IC5521, IC5522, IC5523, IC5524, IC5525, IC5237, IC5216, IC5217, IC5236, IC5238. 2. Product Code: 0042-0000-CA; GTIN Number: 813502011272; Serial Numbers: IC9416, IC9414, IC9415, IC9413, IC8283, IC7695, IC7716, IC7694, IC6633, IC6634, IC6635, IC6636, IC6082, IC6083, IC5821, IC5824, IC5680, IC5034, IC5050, IC4944, IC4945, IC3802, IC3803, IC3661, IC3662, IC2686, IC2687, IC2369, IC2370, IC2033, IC2035, IC2032, IC2034, IC1911, IC1912, IC1913, IC1790, IC1791, IC1715, IC1769, IC1664, IC1665, IC1595, IC1598, IC1572, IC1543, IC1544, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN Number: 813502011289; Serial Numbers: IC7809, IC7717, IC7718, IC7719, IC7720, IC7721, IC7748, IC7674, IC7675, IC7686, IC7687, IC7688, IC7689, IC7690, IC7691, IC7692, IC7693, IC7653, IC7654, IC7655, IC7666, IC7667, IC7646, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7613, IC7614, IC7615, IC7421, IC7576, IC7577, IC7578, IC7579, IC7580, IC7581, IC7582, IC7583, IC7584, IC7455, IC7452, IC7453, IC7454, IC7378, IC7388, IC7389, IC7390, IC7392, IC7393, IC7394, IC7407, IC7395, IC7406, IC7263, IC7264, IC7265, IC7286, IC7258, IC7259, IC7260, IC7261, IC7262, IC7087, IC7092, IC7093, IC7094, IC7095, IC7096, IC7097, IC7098, IC7099, IC7100, IC7075, IC7076, IC7077, IC7078, IC6843, IC6844, IC6845, IC6876, IC6877, IC6878, IC6879, IC6880, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6810, IC6812, IC6813, IC6814, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6710, IC6711, IC6712, IC6713, IC6714, IC6715, IC6716, IC6717, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6708, IC6709, IC6587, IC6588, IC6589, IC6590, IC6591, IC6592, IC6593, IC6594, IC6595, IC6577, IC6578, IC6579, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6510, IC6449, IC6469, IC6474, IC6487, IC6488, IC6489, IC6437, IC6439, IC6440, IC6441, IC6443, IC6431, IC6432, IC6435, IC6436, IC6434, IC6370, IC6371, IC6372, IC6373, IC6374, IC6375, IC6386, IC6387, IC6270, IC6331, IC6205, IC6214, IC6216, IC6293, IC6294, IC6272, IC6273, IC6274, IC6275, IC6223, IC6224, IC6225, IC6236, IC6164, IC6165, IC6147, IC6148, IC6149, IC6150, IC6151, IC6078, IC6081, IC6079, IC6080, IC6064, IC6076, IC5817, IC5818, IC5774, IC5775, IC5777, IC5779, IC5781, IC5780, IC5754, IC5755, IC5756, IC5757, IC5611, IC5714, IC5715, IC5716, IC5717, IC5722, IC5681, IC5682, IC5683, IC5684, IC5685, IC5686, IC5688, IC5687, IC5559, IC5560, IC5558, IC5517, IC5518, IC5519, IC5520, IC5495, IC5496, IC5487, IC5488, IC5489, IC5490, IC5491, IC5492, IC5493, IC5494, IC5476, IC5477, IC5357, IC5465, IC5466, IC5467, IC5460, IC5461, IC5462, IC5463, IC5464, IC5440, IC5441, IC5442, IC5443, IC5433, IC5434, IC5435, IC5436, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5251, IC5252, IC5193, IC5194, IC5195, IC5210, IC5212, IC5169, IC5171, IC5173, IC5174, IC5175, IC5176, IC5177, IC5178, IC5051, IC5053, IC5075, IC5086, IC5087, IC5088, IC5046, IC5047, IC5048, IC5049, IC5057, IC5055, IC4973, IC5007, IC5008, IC5009, IC4984, IC4986, IC4987, IC4988, IC4850, IC4928, IC4929, IC4930, IC4931, IC4932, IC4933, IC4934, IC4911, IC4912, IC4913, IC4914, IC4915, IC4916, IC4917, IC4845, IC4846, IC4833, IC4834, IC4835, IC4836, IC4837, IC4839, IC4840, IC4823, IC4824, IC4815, IC4816, IC4817, IC4818, IC4819, IC4820, IC4821, IC4822, IC4790, IC4791, IC4792, IC4793, IC4794, IC4795, IC4796, IC4797, IC4781, IC4748, IC4757, IC4758, IC4759, IC4760, IC4761, IC4762, IC4763, IC4723, IC4724, IC4733, IC4734, IC4735, IC4736, IC4737, IC4738, IC4725, IC4727, IC4728, IC4729, IC4677, IC4678, IC4679, IC4680, IC4681, IC4682, IC4645, IC4646, IC4647, IC4648, IC4649, IC4656, IC4657, IC4658, IC4585, IC4630, IC4631, IC4632, IC4633, IC4634, IC4635, IC4636, IC4623, IC4624, IC4626, IC4627, IC4628, IC4629, IC4609, IC4610, IC4611, IC4612, IC4613, IC4614, IC4594, IC4595, IC4597, IC4598, IC4557, IC4565, IC4566, IC4567, IC4568, IC4569, IC4559, IC4560, IC4561, IC4562, IC4563, IC4564, IC4500, IC4501, IC4502, IC4503, IC4505, IC4506, IC4507, IC4508, IC4464, IC4465, IC4466, IC4467, IC4468, IC4469, IC4470, IC4471, IC4442, IC4443, IC4444, IC4445, IC4446, IC4365, IC4366, IC4367, IC4370, IC4371, IC4356, IC4357, IC4358, IC4359, IC4360, IC4361, IC4362, IC4363, IC4322, IC4323, IC4324, IC4325, IC4326, IC4328, IC4329, IC4251, IC4252, IC4253, IC4254, IC4255, IC4256, IC4257, IC4258, IC4235, IC4236, IC4237, IC4238, IC4241, IC4242, IC4240, IC4233, IC4227, IC4228, IC4229, IC4230, IC4231, IC4232, IC4234, IC4217, IC4218, IC4207, IC4208, IC4209, IC4210, IC4211, IC4212, IC4175, IC4146, IC4147, IC4148, IC4149, IC4150, IC4151, IC4152, IC4153, IC4128, IC4129, IC4096, IC4097, IC4098, IC4099, IC4100, IC4081, IC4083, IC4068, IC4069, IC4054, IC4055, IC4036, IC4037, IC4033, IC4034, IC4035, IC4002, IC4006, IC4012, IC4013, IC4014, IC4015, IC3885, IC3886, IC3887, IC3888, IC3889, IC3891, IC3884, IC3890, IC3868, IC3869, IC3870, IC3871, IC3872, IC3874, IC3875, IC3873, IC3859, IC3861, IC3862, IC3863, IC3864, IC3866, IC3867, IC3860, IC3828, IC3829, IC3830, IC3831, IC3833, IC3834, IC3832, IC3815, IC3816, IC3817, IC3818, IC3812, IC3813, IC3814, IC3777, IC3778, IC3780, IC3781, IC3782, IC3783, IC3776, IC3779, IC3717, IC3724, IC3718, IC3719, IC3720, IC3701, IC3703, IC3706, IC3707, IC3708, IC3709, IC3704, IC3705, IC3696, IC3697, IC3698, IC3699, IC3700, IC3702, IC3657, IC3667, IC3668, IC3669, IC3670, IC3671, IC3672, IC3673, IC3663, IC3664, IC3665, IC3666, IC3492, IC3493, IC3495, IC3656, IC3658, IC3659, IC3494, IC3660, IC3477, IC3485, IC3486, IC3487, IC3488, IC3489, IC3491, IC3490, IC3484, IC3466, IC3467, IC3468, IC3469, IC3470, IC3471, IC3472, IC3458, IC3459, IC3460, IC3461, IC3462, IC3463, IC3313, IC3319, IC3323, IC3329, IC3330, IC3331, IC3332, IC3327, IC3328, IC3314, IC3315, IC3316, IC3317, IC3318, IC3321, IC3322, IC3324, IC3304, IC3305, IC3306, IC3307, IC3308, IC3309, IC3310, IC3311, IC3296, IC3297, IC3298, IC3299, IC3300, IC3303, IC3301, IC3302, IC3286, IC3287, IC3288, IC3289, IC3290, IC3291, IC3292, IC3184, IC3178, IC3179, IC3180, IC3181, IC3182, IC3183, IC3142, IC3143, IC3144, IC3145, IC3146, IC3147, IC3148, IC3149, IC3127, IC3128, IC3129, IC3130, IC3133, IC3134, IC3131, IC3132, IC3095, IC3096, IC3097, IC3098, IC3100, IC3101, IC3099, IC3102, IC3067, IC3068, IC3069, IC3070, IC3048, IC3049, IC3051, IC3052, IC3053, IC3054, IC3050, IC3015, IC3016, IC3017, IC3018, IC3019, IC3020, IC3021, IC3022, IC2996, IC2997, IC2984, IC2985, IC2987, IC2988, IC2989, IC2960, IC2961, IC2962, IC2963, IC2964, IC2873, IC2874, IC2875, IC2876, IC2877, IC2878, IC2855, IC2856, IC2858, IC2859, IC2862, IC2860, IC2861, IC2835, IC2836, IC2837, IC2838, IC2823, IC2824, IC2825, IC2826, IC2828, IC2829, IC2830, IC2827, IC2763, IC2766, IC2767, IC2765, IC2755, IC2756, IC2757, IC2758, IC2753, IC2754, IC2751, IC2752, IC2676, IC2677, IC2678, IC2679, IC2708, IC2709, IC2710, IC2712, IC2668, IC2669, IC2670, IC2652, IC2653, IC2654, IC2655, IC2656, IC2657, IC2658, IC2659, IC2606, IC2607, IC2609, IC2610, IC2559, IC2491, IC2512, IC2534, IC2560, IC2471, IC2481, IC2483, IC2484, IC2485, IC2486, IC2490, IC2494, IC2475, IC2476, IC2477, IC2478, IC2479, IC2469, IC2470, IC2472, IC2473, IC2474, IC2556, IC2557, IC2441, IC2442, IC2443, IC2444, IC2411, IC2412, IC2413, IC2414, IC2380, IC2325, IC2326, IC2327, IC2329, IC2330, IC2331, IC2332, IC2266, IC2267, IC2268, IC2239, IC2240, IC2241, IC2242, IC2243, IC2244, IC2245, IC2231, IC2232, IC2233, IC2234, IC2235, IC2236, IC2220, IC2221, IC2222, IC2219, IC2204, IC2205, IC2206, IC2207, IC2171, IC2172, IC2173, IC2174, IC2178, IC2179, IC2175, IC2095, IC2096, IC2097, IC2098, IC2099, IC2100, IC2101, IC2102, IC2021, IC2038, IC2039, IC2040, IC2005, IC2006, IC1971, IC1972, IC1973, IC1974, IC1975, IC1976, IC1977, IC1978, IC1901, IC1902, IC1903, IC1904, IC1905, IC1907, IC1908, IC1775, IC1780, IC1881, IC1886, IC1870, IC1872, IC1874, IC1871, IC1876, IC1821, IC1822, IC1823, IC1824, IC1825, IC1826, IC1761, IC1763, IC1764, IC1765, IC1766, IC1767, IC1768, IC1720, IC1721, IC1722, IC1723, IC1726, IC1727, IC1724, IC1725, IC1699, IC1700, IC1677, IC1678, IC1684, IC1685, IC1676, IC1653, IC1584, IC1585, IC1587, IC1588, IC1590, IC1591, IC1592, IC1593, IC1594, IC1586, IC1578, IC1579, IC1580, IC1577, IC1546, IC1547, IC1548, IC1549, IC1522, IC1523, IC1524, IC1525, IC1488, IC1490, IC1413, IC1415, IC1411, IC1416, IC1395, IC1396, IC1397, IC1398, IC1393, IC1381, IC1383, IC1384, IC1385, IC1386, IC1347, IC1349, IC1350, IC1340, IC1341, IC1343, IC1344, IC1345, IC1301, IC1302, IC1304, IC1305, IC1284, IC1288, IC1283, IC1285, IC1276, IC1277, IC1278, IC1280, IC1275, IC1265, IC1216, IC1217. 4. Product Code: 0042-0000-EU-L; GTIN Number: 813502011289; Serial Numbers: IC7810, IC6065, IC4910, IC4901, IC4891, IC4892, IC4875, IC4876, IC4879, IC4880, IC4881, IC4874, IC4877, IC4878, IC4867, IC4868, IC4869, IC4870, IC4871, IC4872, IC4873, IC4866, IC4855, IC4847, IC4848, IC4849, IC4851, IC4852, IC4853, IC4838, IC4622, IC4625, IC4364, IC4239, IC4032, IC3827, IC3320, IC2986, IC2857, IC2176, IC1906, IC1762, IC1520, IC1521, IC1487, IC1399, IC1303, IC1011. 5. Product Code: 0042-0000-IN; GTIN Number: 813502011418; Serial Numbers: IC7410, IC7411, IC7408, IC7409, IC7079, IC7080, IC6475, IC6476, IC6477, IC6478, IC6139, IC6252, IC6253, IC6254. 6. Product Code: 0042-0000-JP; GTIN Number: 813502010428; Serial Numbers: IC8276, IC8277, IC8278, IC8279, IC8280, IC8281, IC8282, IC8082, IC8083, IC8084, IC8078, IC8079, IC8080, IC8081, IC8047, IC8048, IC8049, IC8050, IC8051, IC8052, IC8053, IC8054, IC8055, IC8076, IC8077, IC8085, IC7981, IC7982, IC7983, IC7984, IC7985, IC8046, IC7933, IC7934, IC7935, IC7976, IC7977, IC7978, IC7979, IC7980, IC7928, IC7929, IC7902, IC7903, IC7904, IC7905, IC7926, IC7927, IC7899, IC7900, IC7901, IC7852, IC7853, IC7854, IC7855, IC7896, IC7897, IC7898, IC7851, IC7812, IC7813, IC7814, IC7815, IC7846, IC7808, IC7811, IC7784, IC7785, IC7806, IC7779, IC7780, IC7781, IC7782, IC7783, IC7746, IC7747, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7672, IC7673, IC7593, IC7594, IC7595, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7450, IC7451, IC7433, IC7434, IC7435, IC7439, IC7440, IC7412, IC7413, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7383, IC7384, IC7385, IC7386, IC7387, IC7291, IC7293, IC7294, IC7295, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC7068, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6662, IC6642, IC6650, IC6651, IC6652, IC6653, IC6654, IC6656, IC6657, IC6658, IC6659, IC6660, IC6661, IC6519, IC6605, IC6606, IC6607, IC6610, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6533, IC6429, IC6430, IC6452, IC6490, IC6491, IC6492, IC6442, IC6451, IC6466, IC6467, IC6468, IC6405, IC6406, IC6407, IC6388, IC6389, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6202, IC6203, IC6204, IC6210, IC6211, IC6212, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6091, IC6046, IC6047, IC6048, IC6049, IC5929, IC5930, IC5935, IC5936, IC5937, IC5938, IC5928, IC5864, IC5865, IC5866, IC5867, IC5868, IC5819, IC5820, IC5860, IC5861, IC5862, IC5863, IC5727, IC5728, IC5729, IC5731, IC5732, IC5733, IC5734, IC5735, IC5556, IC5563, IC5651, IC5652, IC5653, IC5654, IC5656, IC5657, IC5658, IC5659, IC5660, IC5665, IC5700, IC5505, IC5506, IC5507, IC5510, IC5511, IC5512, IC5515, IC5516, IC5478, IC5447, IC5444, IC5445, IC5259, IC5260, IC5261, IC5241, IC5243, IC5245, IC5027, IC4732....

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, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and 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: Aug 6, 2025
Recall initiation date: Jun 23, 2025
Center classification date: Jul 25, 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

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