Recall archive / FDA device enforcement

Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresp... — FDA record Z-2360-2026

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 May 14, 2026. 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), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 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, IN; Product Code: 0042-0000-IN. 5. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 6. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 7. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 8. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 9. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 10. Impella Optical Controller, Packaged, IN; Product Code: 0042-0010-IN. 11. Impella Optical Controller, Packaged, UK; Product Code: 0042-0010-UK. 12.Impella Optical Controller, Packaged, US, UK; Product Code: 0042-0010-US. 13. Optical AIC w/Impella Connect, Pack'd, CA; Product Code: 0042-0040-CA. 14. Optical AIC w/Impella Connect, Pack'd, EU; Product Code: 0042-0040-EU. 15. Optical AIC w/Impella Connect, Pack'd, JP, EU; Product Code: 0042-0040-JP. 16. Optical, AIC, Impella Connect, Pkgd, AU; Product Code: 0042-0040-AU. 17. Optical, AIC, Impella Connect, Pkgd, UK; Product Code: 0042-0040-UK. 18. Optical, AIC, Impella Connect, Pkgd, US; Product Code: 0042-0040-US.
Reason: Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Classification: Class I
Recalling firm: Abiomed, Inc.
Quantity: 10,297 units
Agency-reported status: Ongoing
Source record identifier: Z-2360-2026

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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	All products below with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above. 1. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers: IC5341, IC5523, IC5677, IC6531, IC5525, IC6529, IC5836, IC5524, IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6527, IC6526, IC6528, IC6530, IC5622, IC5752, IC5521, IC5522, IC5217, IC5216. 2. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC9415, IC9413, IC9416, IC9414, IC8283, IC7716, IC7695, IC7694, IC6635, IC6636, IC6633, IC6634, IC6082, IC6083, IC5821, IC5824, IC5680, IC3802, IC2035, IC1912, IC5034, IC5050, IC4944, IC4945, IC3803, IC3661, IC3662, IC2686, IC2687, IC2033, IC1913, IC1790, IC1791, IC1911, IC1715, IC1769, IC1664, IC1595, IC1598, IC1543, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC7809, IC7720, IC7721, IC7748, IC7719, IC7718, IC7717, IC7691, IC7692, IC7693, IC7689, IC7690, IC7687, IC7688, IC7675, IC7686, IC7674, IC7667, IC7655, IC7666, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7646, IC7653, IC7654, IC7613, IC7614, IC7615, IC7580, IC7578, IC7579, IC7576, IC7577, IC7421, IC7455, IC7407, IC7395, IC7406, IC7393, IC7394, IC7388, IC7389, IC7390, IC7392, IC7378, IC7286, IC7265, IC7263, IC7264, IC7261, IC7262, IC7258, IC7259, IC7260, IC7098, IC7099, IC7100, IC7078, IC7093, IC7087, IC7092, IC7096, IC7097, IC7094, IC7095, IC7077, IC7075, IC7076, IC6880, IC6876, IC6877, IC6878, IC6879, IC6845, IC6843, IC6813, IC6814, IC6810, IC6812, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6716, IC6717, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6713, IC6714, IC6710, IC6712, IC6711, IC6715, IC6708, IC6709, IC6594, IC6595, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6591, IC6592, IC6593, IC6579, IC6577, IC6578, IC6587, IC6588, IC6589, IC6590, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6487, IC6488, IC6449, IC6469, IC6441, IC6443, IC6440, IC6436, IC6437, IC6439, IC6432, IC6435, IC6434, IC6431, IC6331, IC6270, IC6064, IC6205, IC6275, IC6273, IC6274, IC6225, IC6236, IC6272, IC6223, IC6224, IC6149, IC6150, IC6151, IC6147, IC6081, IC6078, IC5818, IC5817, IC5781, IC5775, IC5777, IC5779, IC5755, IC5756, IC5754, IC5715, IC5716, IC5717, IC5685, IC5686, IC5611, IC5714, IC5722, IC5683, IC5684, IC5688, IC5560, IC5681, IC5682, IC5559, IC5518, IC5520, IC5517, IC5177, IC4839, IC4565, IC5519, IC5495, IC5496, IC5494, IC5490, IC5491, IC5492, IC5493, IC5487, IC5488, IC5476, IC5477, IC5460, IC5461, IC5463, IC5464, IC5462, IC5443, IC5441, IC5442, IC5440, IC5435, IC5436, IC5433, IC5434, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5252, IC5195, IC5048, IC5193, IC5194, IC5178, IC5175, IC5176, IC5173, IC5174, IC5210, IC5212, IC5171, IC5169, IC5086, IC5051, IC5053, IC5075, IC5057, IC5087, IC5088, IC5046, IC5047, IC5049, IC5008, IC5009, IC4973, IC5007, IC4984, IC4986, IC4987, IC4988, IC4933, IC4934, IC4931, IC4932, IC4850, IC4928, IC4929, IC4930, IC4623, IC4470, IC4912, IC4917, IC4913, IC4915, IC4914, IC4916, IC4846, IC4837, IC4833, IC4834, IC4835, IC4836, IC4823, IC4824, IC4821, IC4822, IC4845, IC4840, IC4819, IC4820, IC4817, IC4818, IC4815, IC4816, IC4796, IC4797, IC4792, IC4793, IC4794, IC4795, IC4763, IC4790, IC4791, IC4781, IC4762, IC4760, IC4761, IC4758, IC4759, IC4748, IC4757, IC4737, IC4738, IC4735, IC4736, IC4733, IC4734, IC4723, IC4724, IC4728, IC4729, IC4725, IC4727, IC4679, IC4680, IC4677, IC4678, IC4657, IC4658, IC4648, IC4649, IC4646, IC4647, IC4645, IC4656, IC4634, IC4635, IC4636, IC4632, IC4633, IC4630, IC4631, IC4585, IC4629, IC4626, IC4624, IC4627, IC4613, IC4614, IC4611, IC4569, IC4566, IC4568, IC4610, IC4612, IC4609, IC4597, IC4598, IC4557, IC4567, IC4594, IC4595, IC4559, IC4564, IC4560, IC4561, IC4562, IC4563, IC4505, IC4506, IC4508, IC4501, IC4471, IC4500, IC4469, IC4466, IC4467, IC4464, IC4465, IC4468, IC4442, IC4443, IC4444, IC4445, IC4446, IC4370, IC4371, IC4367, IC4365, IC4366, IC4361, IC4359, IC4360, IC4358, IC4329, IC4328, IC4234, IC4362, IC4363, IC4356, IC4357, IC4323, IC4324, IC4325, IC4326, IC4322, IC4258, IC4252, IC4253, IC4251, IC4242, IC4241, IC4240, IC4254, IC4255, IC4256, IC4235, IC4238, IC4236, IC4230, IC4227, IC4228, IC4229, IC4210, IC4212, IC4207, IC4208, IC4218, IC4217, IC4209, IC4211, IC4175, IC4153, IC4151, IC4152, IC4150, IC4146, IC4147, IC4148, IC4149, IC4128, IC4129, IC4099, IC4100, IC4096, IC4097, IC4098, IC4083, IC4081, IC4036, IC4037, IC4034, IC4035, IC4033, IC4002, IC4006, IC4012, IC4013, IC4014, IC4015, IC3891, IC3889, IC3866, IC3867, IC3868, IC3869, IC3859, IC3861, IC3833, IC3834, IC3862, IC3863, IC3885, IC3886, IC3884, IC3870, IC3871, IC3872, IC3873, IC3874, IC3864, IC3860, IC3832, IC3830, IC3831, IC3828, IC3829, IC3815, IC3816, IC3777, IC3817, IC3818, IC3813, IC3814, IC3781, IC3782, IC3780, IC3812, IC3778, IC3724, IC3718, IC2710, IC3717, IC3706, IC3707, IC3708, IC3701, IC3703, IC3709, IC3698, IC3702, IC3699, IC3700, IC3697, IC3696, IC3673, IC3671, IC3672, IC3668, IC3670, IC3657, IC3669, IC3667, IC3495, IC3489, IC3492, IC3493, IC3486, IC3488, IC3487, IC3491, IC3659, IC3660, IC3490, IC3485, IC3484, IC3477, IC3472, IC3469, IC3470, IC3471, IC3467, IC3461, IC3462, IC3463, IC3466, IC3468, IC3458, IC3459, IC3331, IC3332, IC3460, IC3330, IC3329, IC3323, IC3313, IC3319, IC3327, IC3328, IC3324, IC3303, IC3321, IC3322, IC3317, IC3318, IC3315, IC3310, IC3314, IC3316, IC3311, IC3304, IC3305, IC3301, IC3302, IC3299, IC3300, IC3297, IC3298, IC3296, IC3291, IC3290, IC3289, IC3292, IC3286, IC3288, IC3287, IC3182, IC3183, IC3180, IC3181, IC3178, IC3179, IC3143, IC3144, IC3145, IC3146, IC3142, IC3147, IC3148, IC3149, IC3133, IC3134, IC3100, IC3101, IC3099, IC3102, IC3097, IC3098, IC3095, IC3096, IC3069, IC3070, IC3067, IC3068, IC3053, IC3054, IC3051, IC3052, IC3049, IC3021, IC3022, IC3018, IC3020, IC3019, IC3015, IC3016, IC3017, IC2996, IC2997, IC2987, IC2988, IC2984, IC2985, IC2960, IC2878, IC2961, IC2963, IC2962, IC2964, IC2873, IC2874, IC2875, IC2876, IC2877, IC2862, IC2860, IC2861, IC2858, IC2859, IC2855, IC2856, IC2829, IC2830, IC2835, IC2837, IC2836, IC2838, IC2828, IC2827, IC2766, IC2765, IC2823, IC2824, IC2825, IC2826, IC2763, IC2767, IC2757, IC2758, IC2712, IC2610, IC2751, IC2709, IC2752, IC2708, IC2678, IC2679, IC2676, IC2677, IC2670, IC2669, IC2668, IC2659, IC2658, IC2656, IC2657, IC2654, IC2655, IC2652, IC2653, IC2607, IC2609, IC2606, IC2560, IC2512, IC2556, IC2557, IC2491, IC2534, IC2490, IC2494, IC2483, IC2486, IC2481, IC2484, IC2485, IC2475, IC2441, IC2473, IC2474, IC2413, IC2414, IC2469, IC2470, IC2472, IC2412, IC2332, IC2411, IC2330, IC2329, IC2326, IC2327, IC2325, IC2242, IC2267, IC2268, IC2266, IC2241, IC2243, IC2234, IC2236, IC2232, IC2233, IC2204, IC2207, IC2222, IC2206, IC2220, IC2205, IC2099, IC2178, IC2179, IC2239, IC2240, IC2244, IC2235, IC2231, IC2173, IC2174, IC2171, IC2172, IC2101, IC2102, IC2095, IC2098, IC2097, IC2100, IC2096, IC2038, IC2039, IC2005, IC2006, IC1977, IC1978, IC1975, IC1976, IC1974, IC1886, IC1971, IC1972, IC1973, IC1908, IC1904, IC1907, IC1902, IC1903, IC1901, IC1881, IC1905, IC1775, IC1780, IC1872, IC1874, IC1870, IC1876, IC1825, IC1826, IC1821, IC1824, IC1764, IC1822, IC1823, IC1767, IC1768, IC1763, IC1766, IC1765, IC1727, IC1726, IC1761, IC1722, IC1723, IC1720, IC1685, IC1699, IC1700, IC1684, IC1677, IC1678, IC1676, IC1653, IC1594, IC1584, IC1590, IC1592, IC1490, IC1591, IC1585, IC1588, IC1578, IC1580, IC1579, IC1549, IC1547, IC1546, IC1548, IC1522, IC1523, IC1524, IC1525, IC1488, IC1413, IC1415, IC1411, IC1396, IC1397, IC1383, IC1350, IC1395, IC1384, IC1381, IC1393, IC1386, IC1344, IC1341, IC1343, IC1340, IC1345, IC1347, IC1349, IC1276, IC1288, IC1301, IC1302, IC1304, IC1305, IC1275, IC1265, IC1217. 4. Product Code: 0042-0000-IN; GTIN: 00813502011418; Serial Numbers: IC6475, IC6139, IC7410, IC7411, IC7408, IC7409, IC7079, IC7080, IC6477, IC6478, IC6476, IC6252, IC6253, IC6254. 5. Product Code: 0042-0000-JP; GTIN: 00813502010428; Serial Numbers: IC7901, IC8276, IC8277, IC8278, IC8279, IC8281, IC8082, IC8083, IC8084, IC8078, IC8079, IC8080, IC8081, IC8050, IC7929, IC7899, IC7900, IC7808, IC7811, IC8047, IC8048, IC8049, IC8051, IC8053, IC8054, IC8076, IC8077, IC7984, IC7853, IC7981, IC7982, IC7983, IC7985, IC8046, IC7934, IC7905, IC7926, IC7927, IC7933, IC7976, IC7979, IC7935, IC7977, IC7978, IC7980, IC7779, IC7902, IC7903, IC7897, IC7898, IC7852, IC7896, IC7812, IC7813, IC7814, IC7815, IC7846, IC7784, IC7785, IC7806, IC7782, IC7783, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7672, IC7673, IC7413, IC7593, IC7594, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7450, IC7451, IC7434, IC7435, IC7439, IC7440, IC7433, IC7412, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7385, IC7386, IC7387, IC7383, IC7384, IC7291, IC7293, IC7294, IC7295, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7068, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6658, IC6659, IC6652, IC6653, IC6654, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6642, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6662, IC6650, IC6651, IC6656, IC6657, IC6660, IC6661, IC6519, IC6605, IC6606, IC6607, IC6610, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6468, IC6533, IC6429, IC6430, IC6452, IC6490, IC6491, IC6492, IC6442, IC6451, IC6466, IC6467, IC6405, IC6406, IC6407, IC6388, IC6389, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6203, IC6204, IC6210, IC6211, IC6212, IC5866, IC5867, IC5868, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6049, IC6046, IC6047, IC6048, IC5935, IC5936, IC5937, IC5938, IC5862, IC5863, IC5930, IC5864, IC5865, IC5819, IC5820, IC5860, IC5861, 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. 6. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC7668, IC7669, IC7670, IC7591, IC7073, IC7847, IC7848, IC7585, IC7443, IC7441, IC7074, IC7671, IC7070, IC7071, IC7444, IC7445, IC7446, IC7447, IC7069, IC7057, IC7056, IC6925, IC6585, IC6586, IC6583, IC6584, IC6542, IC6543, IC6537, IC6538, IC6638, IC6669, IC6670, IC6671, IC6291, IC6292, IC6286, IC6287, IC6289, IC6290, IC5914, IC5915, IC5926, IC5927, IC6001, IC5995, IC5996, IC5997, IC5998, IC5999, IC5910, IC5833, IC5831, IC5832, IC5554, IC5555, IC5553, IC5247, IC5830, IC5557, IC5213, IC5182, IC5180, IC5211, IC5254, IC5253, IC5219, IC5220, IC5218, IC5184, IC5214, IC5215, IC5179, IC5181, IC4857, IC4843, IC4844, IC4841, IC4842, IC4926, IC4927, IC4739, IC4741, IC4721, IC4722, IC4599, IC4600, IC4439, IC4440, IC4330, IC4166, IC3784, IC3785, IC3674, IC3474, IC3334, IC3333, IC3326, IC3325, IC3312, IC3295, IC3293, IC3294, IC2871, IC2872, IC2706, IC2707, IC2704, IC2705, IC2493, IC2497, IC2492, IC2496, IC2367, IC2023, IC1910, IC2024, IC2025, IC1909, IC1869, IC1868, IC1792, IC1581, IC1582, IC1583, IC1542, IC1519, IC1573, IC1387, IC1389, IC1388. 7. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC4744, IC7919, IC7922, IC7026, IC7028, IC7027, IC7030, IC7032, IC6983, IC6984, IC6982, IC6976, IC6977, IC6978, IC6979, IC6980, IC6981, IC6930, IC6931, IC6932, IC6933, IC6935, IC6926, IC6927, IC6928, IC6929, IC6918, IC6919, IC6920, IC6921, IC6922, IC6923, IC6898, IC6897, IC6916, IC6917, IC6889, IC6893, IC6894, IC6895, IC6901, IC6914, IC6915, IC6908, IC6909, IC6910, IC6911, IC6912, IC6913, IC6896, IC6899, IC6900, IC6904, IC6905, IC6906, IC6907, IC6841, IC6842, IC6840, IC68...

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Details supplied by the agency

Lot, code or applicability

All products below with software versions 6.0.1, 6.0.2, 6.0.3, 7.1 and above. 1. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers: IC5341, IC5523, IC5677, IC6531, IC5525, IC6529, IC5836, IC5524, IC7849, IC7850, IC7287, IC7288, IC7289, IC7290, IC6527, IC6526, IC6528, IC6530, IC5622, IC5752, IC5521, IC5522, IC5217, IC5216. 2. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers: IC9415, IC9413, IC9416, IC9414, IC8283, IC7716, IC7695, IC7694, IC6635, IC6636, IC6633, IC6634, IC6082, IC6083, IC5821, IC5824, IC5680, IC3802, IC2035, IC1912, IC5034, IC5050, IC4944, IC4945, IC3803, IC3661, IC3662, IC2686, IC2687, IC2033, IC1913, IC1790, IC1791, IC1911, IC1715, IC1769, IC1664, IC1595, IC1598, IC1543, IC1480, IC1481, IC1324, IC1346. 3. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers: IC7809, IC7720, IC7721, IC7748, IC7719, IC7718, IC7717, IC7691, IC7692, IC7693, IC7689, IC7690, IC7687, IC7688, IC7675, IC7686, IC7674, IC7667, IC7655, IC7666, IC7647, IC7648, IC7649, IC7650, IC7651, IC7652, IC7646, IC7653, IC7654, IC7613, IC7614, IC7615, IC7580, IC7578, IC7579, IC7576, IC7577, IC7421, IC7455, IC7407, IC7395, IC7406, IC7393, IC7394, IC7388, IC7389, IC7390, IC7392, IC7378, IC7286, IC7265, IC7263, IC7264, IC7261, IC7262, IC7258, IC7259, IC7260, IC7098, IC7099, IC7100, IC7078, IC7093, IC7087, IC7092, IC7096, IC7097, IC7094, IC7095, IC7077, IC7075, IC7076, IC6880, IC6876, IC6877, IC6878, IC6879, IC6845, IC6843, IC6813, IC6814, IC6810, IC6812, IC6804, IC6805, IC6806, IC6807, IC6808, IC6809, IC6716, IC6717, IC6728, IC6738, IC6739, IC6740, IC6741, IC6742, IC6713, IC6714, IC6710, IC6712, IC6711, IC6715, IC6708, IC6709, IC6594, IC6595, IC6688, IC6689, IC6690, IC6691, IC6692, IC6693, IC6694, IC6695, IC6706, IC6707, IC6591, IC6592, IC6593, IC6579, IC6577, IC6578, IC6587, IC6588, IC6589, IC6590, IC6582, IC6580, IC6581, IC6534, IC6535, IC6536, IC6487, IC6488, IC6449, IC6469, IC6441, IC6443, IC6440, IC6436, IC6437, IC6439, IC6432, IC6435, IC6434, IC6431, IC6331, IC6270, IC6064, IC6205, IC6275, IC6273, IC6274, IC6225, IC6236, IC6272, IC6223, IC6224, IC6149, IC6150, IC6151, IC6147, IC6081, IC6078, IC5818, IC5817, IC5781, IC5775, IC5777, IC5779, IC5755, IC5756, IC5754, IC5715, IC5716, IC5717, IC5685, IC5686, IC5611, IC5714, IC5722, IC5683, IC5684, IC5688, IC5560, IC5681, IC5682, IC5559, IC5518, IC5520, IC5517, IC5177, IC4839, IC4565, IC5519, IC5495, IC5496, IC5494, IC5490, IC5491, IC5492, IC5493, IC5487, IC5488, IC5476, IC5477, IC5460, IC5461, IC5463, IC5464, IC5462, IC5443, IC5441, IC5442, IC5440, IC5435, IC5436, IC5433, IC5434, IC5331, IC5356, IC5421, IC5422, IC5391, IC5392, IC5252, IC5195, IC5048, IC5193, IC5194, IC5178, IC5175, IC5176, IC5173, IC5174, IC5210, IC5212, IC5171, IC5169, IC5086, IC5051, IC5053, IC5075, IC5057, IC5087, IC5088, IC5046, IC5047, IC5049, IC5008, IC5009, IC4973, IC5007, IC4984, IC4986, IC4987, IC4988, IC4933, IC4934, IC4931, IC4932, IC4850, IC4928, IC4929, IC4930, IC4623, IC4470, IC4912, IC4917, IC4913, IC4915, IC4914, IC4916, IC4846, IC4837, IC4833, IC4834, IC4835, IC4836, IC4823, IC4824, IC4821, IC4822, IC4845, IC4840, IC4819, IC4820, IC4817, IC4818, IC4815, IC4816, IC4796, IC4797, IC4792, IC4793, IC4794, IC4795, IC4763, IC4790, IC4791, IC4781, IC4762, IC4760, IC4761, IC4758, IC4759, IC4748, IC4757, IC4737, IC4738, IC4735, IC4736, IC4733, IC4734, IC4723, IC4724, IC4728, IC4729, IC4725, IC4727, IC4679, IC4680, IC4677, IC4678, IC4657, IC4658, IC4648, IC4649, IC4646, IC4647, IC4645, IC4656, IC4634, IC4635, IC4636, IC4632, IC4633, IC4630, IC4631, IC4585, IC4629, IC4626, IC4624, IC4627, IC4613, IC4614, IC4611, IC4569, IC4566, IC4568, IC4610, IC4612, IC4609, IC4597, IC4598, IC4557, IC4567, IC4594, IC4595, IC4559, IC4564, IC4560, IC4561, IC4562, IC4563, IC4505, IC4506, IC4508, IC4501, IC4471, IC4500, IC4469, IC4466, IC4467, IC4464, IC4465, IC4468, IC4442, IC4443, IC4444, IC4445, IC4446, IC4370, IC4371, IC4367, IC4365, IC4366, IC4361, IC4359, IC4360, IC4358, IC4329, IC4328, IC4234, IC4362, IC4363, IC4356, IC4357, IC4323, IC4324, IC4325, IC4326, IC4322, IC4258, IC4252, IC4253, IC4251, IC4242, IC4241, IC4240, IC4254, IC4255, IC4256, IC4235, IC4238, IC4236, IC4230, IC4227, IC4228, IC4229, IC4210, IC4212, IC4207, IC4208, IC4218, IC4217, IC4209, IC4211, IC4175, IC4153, IC4151, IC4152, IC4150, IC4146, IC4147, IC4148, IC4149, IC4128, IC4129, IC4099, IC4100, IC4096, IC4097, IC4098, IC4083, IC4081, IC4036, IC4037, IC4034, IC4035, IC4033, IC4002, IC4006, IC4012, IC4013, IC4014, IC4015, IC3891, IC3889, IC3866, IC3867, IC3868, IC3869, IC3859, IC3861, IC3833, IC3834, IC3862, IC3863, IC3885, IC3886, IC3884, IC3870, IC3871, IC3872, IC3873, IC3874, IC3864, IC3860, IC3832, IC3830, IC3831, IC3828, IC3829, IC3815, IC3816, IC3777, IC3817, IC3818, IC3813, IC3814, IC3781, IC3782, IC3780, IC3812, IC3778, IC3724, IC3718, IC2710, IC3717, IC3706, IC3707, IC3708, IC3701, IC3703, IC3709, IC3698, IC3702, IC3699, IC3700, IC3697, IC3696, IC3673, IC3671, IC3672, IC3668, IC3670, IC3657, IC3669, IC3667, IC3495, IC3489, IC3492, IC3493, IC3486, IC3488, IC3487, IC3491, IC3659, IC3660, IC3490, IC3485, IC3484, IC3477, IC3472, IC3469, IC3470, IC3471, IC3467, IC3461, IC3462, IC3463, IC3466, IC3468, IC3458, IC3459, IC3331, IC3332, IC3460, IC3330, IC3329, IC3323, IC3313, IC3319, IC3327, IC3328, IC3324, IC3303, IC3321, IC3322, IC3317, IC3318, IC3315, IC3310, IC3314, IC3316, IC3311, IC3304, IC3305, IC3301, IC3302, IC3299, IC3300, IC3297, IC3298, IC3296, IC3291, IC3290, IC3289, IC3292, IC3286, IC3288, IC3287, IC3182, IC3183, IC3180, IC3181, IC3178, IC3179, IC3143, IC3144, IC3145, IC3146, IC3142, IC3147, IC3148, IC3149, IC3133, IC3134, IC3100, IC3101, IC3099, IC3102, IC3097, IC3098, IC3095, IC3096, IC3069, IC3070, IC3067, IC3068, IC3053, IC3054, IC3051, IC3052, IC3049, IC3021, IC3022, IC3018, IC3020, IC3019, IC3015, IC3016, IC3017, IC2996, IC2997, IC2987, IC2988, IC2984, IC2985, IC2960, IC2878, IC2961, IC2963, IC2962, IC2964, IC2873, IC2874, IC2875, IC2876, IC2877, IC2862, IC2860, IC2861, IC2858, IC2859, IC2855, IC2856, IC2829, IC2830, IC2835, IC2837, IC2836, IC2838, IC2828, IC2827, IC2766, IC2765, IC2823, IC2824, IC2825, IC2826, IC2763, IC2767, IC2757, IC2758, IC2712, IC2610, IC2751, IC2709, IC2752, IC2708, IC2678, IC2679, IC2676, IC2677, IC2670, IC2669, IC2668, IC2659, IC2658, IC2656, IC2657, IC2654, IC2655, IC2652, IC2653, IC2607, IC2609, IC2606, IC2560, IC2512, IC2556, IC2557, IC2491, IC2534, IC2490, IC2494, IC2483, IC2486, IC2481, IC2484, IC2485, IC2475, IC2441, IC2473, IC2474, IC2413, IC2414, IC2469, IC2470, IC2472, IC2412, IC2332, IC2411, IC2330, IC2329, IC2326, IC2327, IC2325, IC2242, IC2267, IC2268, IC2266, IC2241, IC2243, IC2234, IC2236, IC2232, IC2233, IC2204, IC2207, IC2222, IC2206, IC2220, IC2205, IC2099, IC2178, IC2179, IC2239, IC2240, IC2244, IC2235, IC2231, IC2173, IC2174, IC2171, IC2172, IC2101, IC2102, IC2095, IC2098, IC2097, IC2100, IC2096, IC2038, IC2039, IC2005, IC2006, IC1977, IC1978, IC1975, IC1976, IC1974, IC1886, IC1971, IC1972, IC1973, IC1908, IC1904, IC1907, IC1902, IC1903, IC1901, IC1881, IC1905, IC1775, IC1780, IC1872, IC1874, IC1870, IC1876, IC1825, IC1826, IC1821, IC1824, IC1764, IC1822, IC1823, IC1767, IC1768, IC1763, IC1766, IC1765, IC1727, IC1726, IC1761, IC1722, IC1723, IC1720, IC1685, IC1699, IC1700, IC1684, IC1677, IC1678, IC1676, IC1653, IC1594, IC1584, IC1590, IC1592, IC1490, IC1591, IC1585, IC1588, IC1578, IC1580, IC1579, IC1549, IC1547, IC1546, IC1548, IC1522, IC1523, IC1524, IC1525, IC1488, IC1413, IC1415, IC1411, IC1396, IC1397, IC1383, IC1350, IC1395, IC1384, IC1381, IC1393, IC1386, IC1344, IC1341, IC1343, IC1340, IC1345, IC1347, IC1349, IC1276, IC1288, IC1301, IC1302, IC1304, IC1305, IC1275, IC1265, IC1217. 4. Product Code: 0042-0000-IN; GTIN: 00813502011418; Serial Numbers: IC6475, IC6139, IC7410, IC7411, IC7408, IC7409, IC7079, IC7080, IC6477, IC6478, IC6476, IC6252, IC6253, IC6254. 5. Product Code: 0042-0000-JP; GTIN: 00813502010428; Serial Numbers: IC7901, IC8276, IC8277, IC8278, IC8279, IC8281, IC8082, IC8083, IC8084, IC8078, IC8079, IC8080, IC8081, IC8050, IC7929, IC7899, IC7900, IC7808, IC7811, IC8047, IC8048, IC8049, IC8051, IC8053, IC8054, IC8076, IC8077, IC7984, IC7853, IC7981, IC7982, IC7983, IC7985, IC8046, IC7934, IC7905, IC7926, IC7927, IC7933, IC7976, IC7979, IC7935, IC7977, IC7978, IC7980, IC7779, IC7902, IC7903, IC7897, IC7898, IC7852, IC7896, IC7812, IC7813, IC7814, IC7815, IC7846, IC7784, IC7785, IC7806, IC7782, IC7783, IC7749, IC7750, IC7751, IC7752, IC7753, IC7754, IC7755, IC7672, IC7673, IC7413, IC7593, IC7594, IC7606, IC7607, IC7608, IC7609, IC7610, IC7611, IC7612, IC7450, IC7451, IC7434, IC7435, IC7439, IC7440, IC7433, IC7412, IC7414, IC7415, IC7416, IC7417, IC7420, IC7422, IC7423, IC7424, IC7425, IC7426, IC7427, IC7429, IC7430, IC7431, IC7376, IC7377, IC7379, IC7380, IC7381, IC7382, IC7385, IC7386, IC7387, IC7383, IC7384, IC7291, IC7293, IC7294, IC7295, IC6985, IC7029, IC7031, IC7033, IC7034, IC7035, IC7102, IC7103, IC7104, IC7105, IC7256, IC7257, IC7081, IC7082, IC7083, IC7084, IC7085, IC7089, IC7090, IC7091, IC7068, IC7058, IC7059, IC7060, IC7061, IC7062, IC7063, IC7064, IC7065, IC7066, IC7067, IC6882, IC6883, IC6885, IC6886, IC6887, IC6888, IC6658, IC6659, IC6652, IC6653, IC6654, IC6855, IC6856, IC6857, IC6858, IC6859, IC6860, IC6861, IC6862, IC6863, IC6642, IC6745, IC6746, IC6747, IC6748, IC6749, IC6750, IC6751, IC6752, IC6662, IC6650, IC6651, IC6656, IC6657, IC6660, IC6661, IC6519, IC6605, IC6606, IC6607, IC6610, IC6548, IC6549, IC6550, IC6551, IC6552, IC6553, IC6554, IC6555, IC6556, IC6468, IC6533, IC6429, IC6430, IC6452, IC6490, IC6491, IC6492, IC6442, IC6451, IC6466, IC6467, IC6405, IC6406, IC6407, IC6388, IC6389, IC6306, IC6307, IC6308, IC6309, IC6310, IC6311, IC6312, IC6313, IC6314, IC6315, IC6316, IC6203, IC6204, IC6210, IC6211, IC6212, IC5866, IC5867, IC5868, IC6084, IC6085, IC6086, IC6087, IC6088, IC6089, IC6090, IC6049, IC6046, IC6047, IC6048, IC5935, IC5936, IC5937, IC5938, IC5862, IC5863, IC5930, IC5864, IC5865, IC5819, IC5820, IC5860, IC5861, 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. 6. Product Code: 0042-0000-UK; GTIN: 00813502011296; Serial Numbers: IC7668, IC7669, IC7670, IC7591, IC7073, IC7847, IC7848, IC7585, IC7443, IC7441, IC7074, IC7671, IC7070, IC7071, IC7444, IC7445, IC7446, IC7447, IC7069, IC7057, IC7056, IC6925, IC6585, IC6586, IC6583, IC6584, IC6542, IC6543, IC6537, IC6538, IC6638, IC6669, IC6670, IC6671, IC6291, IC6292, IC6286, IC6287, IC6289, IC6290, IC5914, IC5915, IC5926, IC5927, IC6001, IC5995, IC5996, IC5997, IC5998, IC5999, IC5910, IC5833, IC5831, IC5832, IC5554, IC5555, IC5553, IC5247, IC5830, IC5557, IC5213, IC5182, IC5180, IC5211, IC5254, IC5253, IC5219, IC5220, IC5218, IC5184, IC5214, IC5215, IC5179, IC5181, IC4857, IC4843, IC4844, IC4841, IC4842, IC4926, IC4927, IC4739, IC4741, IC4721, IC4722, IC4599, IC4600, IC4439, IC4440, IC4330, IC4166, IC3784, IC3785, IC3674, IC3474, IC3334, IC3333, IC3326, IC3325, IC3312, IC3295, IC3293, IC3294, IC2871, IC2872, IC2706, IC2707, IC2704, IC2705, IC2493, IC2497, IC2492, IC2496, IC2367, IC2023, IC1910, IC2024, IC2025, IC1909, IC1869, IC1868, IC1792, IC1581, IC1582, IC1583, IC1542, IC1519, IC1573, IC1387, IC1389, IC1388. 7. Product Code: 0042-0000-US; GTIN: 00813502010022; Serial Numbers: IC4744, IC7919, IC7922, IC7026, IC7028, IC7027, IC7030, IC7032, IC6983, IC6984, IC6982, IC6976, IC6977, IC6978, IC6979, IC6980, IC6981, IC6930, IC6931, IC6932, IC6933, IC6935, IC6926, IC6927, IC6928, IC6929, IC6918, IC6919, IC6920, IC6921, IC6922, IC6923, IC6898, IC6897, IC6916, IC6917, IC6889, IC6893, IC6894, IC6895, IC6901, IC6914, IC6915, IC6908, IC6909, IC6910, IC6911, IC6912, IC6913, IC6896, IC6899, IC6900, IC6904, IC6905, IC6906, IC6907, IC6841, IC6842, IC6840, IC68...

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 the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, 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: Jun 24, 2026
Recall initiation date: May 14, 2026
Center classification date: Jun 12, 2026

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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