Recall archive / FDA device enforcement

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connec... — FDA record Z-0136-2026

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 Sep 16, 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) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU. 6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN. 7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP. 8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK. 9. Impella Controller, Packaged, US, Product Code: 0042-0000-US. 10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU. 11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU. 12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN. 13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK. 14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US. 15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP. 16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L. 17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA. 18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU. 19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU. 20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK. 21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.
Reason: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Classification: Class I
Recalling firm: Abiomed, Inc.
Quantity: 9,177 total distributed units (754 pending correction)
Agency-reported status: Ongoing
Source record identifier: Z-0136-2026

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: 1000432; GTIN: 00813502013030; Serial Numbers pending correction as of 09/16/2025: IC11239, IC11238, IC10837, IC10497, IC10493, IC10338, IC10362. Serial Numbers corrected as of 09/16/2025: IC11404, IC11401, IC11400, IC11399, IC10827, IC11237, IC11236, IC11232, IC11231, IC11230, IC11227, IC11210, IC11182, IC11153, IC11145, IC11143, IC10854, IC10851, IC10849, IC10703, IC10300, IC10786, IC10785, IC10784, IC10762, IC10755, IC10727, IC10689, IC10672, IC10652, IC10651, IC10650, IC10631, IC10588, IC10586, IC10585, IC10584, IC10518, IC10517, IC10496, IC10494, IC10492, IC10483, IC10365, IC10364, IC10353, IC10170, IC11619, IC11616, IC11611, IC11600. 2. Product Code: 1000201; GTIN: 00813502010442; Serial Numbers pending correction as of 09/16/2025: IC9821, IC9820, IC9819, IC9818, IC9817, IC9816, IC9815, IC9814, IC9813, IC9641, IC9637, IC9636, IC9635, IC9633, IC9632, IC9629. 3. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers pending correction as of 09/16/2025: IC7289, IC7288, IC6531, IC5677, IC5521, IC5238, IC5237, IC5236. Serial Numbers corrected as of 09/16/2025: IC7850, IC7849, IC7290, IC7287, IC6530, IC6529, IC6528, IC6527, IC6526, IC5836, IC5752, IC5622, IC5525, IC5524, IC5523, IC5522, IC5341, IC5217, IC5216. 4. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers pending correction as of 09/16/2025: IC4944, IC2370, IC2369, IC2034, IC2032, IC1715, IC1665, IC1572, IC1544, IC1480. Serial Numbers corrected as of 09/16/2025: IC9416, IC9415, IC9414, IC9413, IC8283, IC7716, IC7695, IC7694, IC6636, IC6635, IC6634, IC6633, IC6083, IC6082, IC5824, IC5821, IC5680, IC5034, IC5050, IC4945, IC3803, IC3802, IC3662, IC3661, IC2687, IC2686, IC2035, IC2033, IC1913, IC1912, IC1911, IC1791, IC1790, IC1769, IC1664, IC1598, IC1595, IC1543, IC1481, IC1346, IC1324. 5. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers pending correction as of 09/16/2025: IC7686, IC7675, IC7584, IC7583, IC7582, IC7581, IC7454, IC7453, IC7452, IC7406, IC7395, IC6880, IC6581, IC6580, IC6578, IC6577, IC6510, IC6489, IC6434, IC6387, IC6386, IC6375, IC6374, IC6373, IC6372, IC6371, IC6370, IC6331, IC6294, IC6293, IC6216, IC6214, IC6165, IC6164, IC5780, IC5779, IC5777, IC5775, IC5687, IC5558, IC5520, IC5492, IC5467, IC5466, IC5465, IC5357, IC5356, IC5251, IC5055, IC4682, IC4681, IC4562, IC4507, IC4358, IC4329, IC4325, IC4257, IC4240, IC4069, IC4068, IC4054, IC3890, IC3888, IC3887, IC3812, IC3783, IC3780, IC3776, IC3720, IC3719, IC3718, IC3705, IC3704, IC3670, IC3666, IC3665, IC3664, IC3663, IC3660, IC3658, IC3656, IC3490, IC3309, IC3308, IC3307, IC3306, IC3302, IC3301, IC3144, IC3132, IC3131, IC3130, IC3129, IC3128, IC3127, IC3102, IC3099, IC3098, IC3050, IC3049, IC2989, IC2861, IC2860, IC2828, IC2827, IC2765, IC2677, IC2676, IC2607, IC2471, IC2479, IC2478, IC2477, IC2476, IC2557, IC2556, IC2444, IC2443, IC2442, IC2222, IC2219, IC2175, IC1876, IC1725, IC1724, IC1678, IC1677, IC1594, IC1577, IC1416, IC1411, IC1345, IC1305, IC1285, IC1284, IC1283, IC1280. Serial Numbers corrected as of 09/16/2025: IC7809, IC7748, IC7721, IC7720, IC7719, IC7718, IC7717, IC7693, IC7692, IC7691, IC7690, IC7689, IC7688, IC7687, IC7674, IC7667, IC7666, IC7655, IC7654, IC7653, IC7652, IC7651, IC7650, IC7649, IC7648, IC7647, IC7646, IC7615, IC7614, IC7613, IC7580, IC7579, IC7578, IC7577, IC7576, IC7421, IC7455, IC7407, IC7394, IC7393, IC7392, IC7390, IC7389, IC7388, IC7378, IC7286, IC7265, IC7264, IC7263, IC7262, IC7261, IC7260, IC7259, IC7258, IC7100, IC7099, IC7098, IC7097, IC7096, IC7095, IC7094, IC7093, IC7092, IC7087, IC7078, IC7077, IC7076, IC7075, IC6879, IC6878, IC6877, IC6876, IC6845, IC6843, IC6814, IC6813, IC6812, IC6810, IC6809, IC6808, IC6807, IC6806, IC6805, IC6804, IC6742, IC6741, IC6740, IC6739, IC6738, IC6728, IC6717, IC6716, IC6715, IC6714, IC6713, IC6712, IC6711, IC6710, IC6709, IC6708, IC6707, IC6706, IC6695, IC6694, IC6693, IC6692, IC6691, IC6690, IC6689, IC6688, IC6595, IC6594, IC6593, IC6592, IC6591, IC6590, IC6589, IC6588, IC6587, IC6582, IC6579, IC6536, IC6535, IC6534, IC6488, IC6487, IC6469, IC6449, IC6443, IC6441, IC6440, IC6439, IC6437, IC6436, IC6435, IC6432, IC6431, IC6270, IC6205, IC6275, IC6274, IC6272, IC6236, IC6225, IC6224, IC6223, IC6151, IC6150, IC6149, IC6147, IC6081, IC6078, IC6064, IC5818, IC5817, IC5781, IC5756, IC5755, IC5754, IC5722, IC5717, IC5716, IC5715, IC5714, IC5611, IC5688, IC5686, IC5685, IC5684, IC5683, IC5682, IC5681, IC5560, IC5559, IC5519, IC5518, IC5517, IC5496, IC5495, IC5494, IC5493, IC5491, IC5490, IC5488, IC5487, IC5477, IC5476, IC5464, IC5463, IC5462, IC5461, IC5460, IC5443, IC5442, IC5441, IC5440, IC5436, IC5435, IC5434, IC5433, IC5422, IC5421, IC5331, IC5392, IC5391, IC5252, IC5195, IC5194, IC5193, IC5212, IC5210, IC5178, IC5177, IC5176, IC5175, IC5174, IC5173, IC5171, IC5169, IC5088, IC5087, IC5086, IC5075, IC5053, IC5051, IC5057, IC5049, IC5048, IC5047, IC5046, IC5009, IC5008, IC5007, IC4973, IC4988, IC4987, IC4986, IC4984, IC4934, IC4933, IC4932, IC4931, IC4930, IC4929, IC4928, IC4850, IC4917, IC4916, IC4915, IC4914, IC4913, IC4846, IC4845, IC4840, IC4839, IC4837, IC4836, IC4835, IC4834, IC4833, IC4824, IC4823, IC4822, IC4821, IC4820, IC4819, IC4818, IC4817, IC4816, IC4815, IC4797, IC4796, IC4795, IC4794, IC4793, IC4792, IC4791, IC4790, IC4781, IC4763, IC4762, IC4761, IC4760, IC4759, IC4758, IC4757, IC4748, IC4738, IC4737, IC4736, IC4735, IC4734, IC4733, IC4724, IC4723, IC4729, IC4728, IC4727, IC4725, IC4680, IC4679, IC4678, IC4677, IC4658, IC4657, IC4656, IC4649, IC4647, IC4646, IC4645, IC4636, IC4635, IC4634, IC4633, IC4632, IC4631, IC4630, IC4585, IC4629, IC4627, IC4626, IC4624, IC4623, IC4614, IC4613, IC4612, IC4611, IC4610, IC4609, IC4598, IC4597, IC4595, IC4594, IC4569, IC4568, IC4567, IC4566, IC4565, IC4557, IC4564, IC4563, IC4561, IC4560, IC4559, IC4508, IC4506, IC4505, IC4501, IC4500, IC4471, IC4470, IC4469, IC4468, IC4467, IC4466, IC4465, IC4464, IC4446, IC4445, IC4444, IC4443, IC4442, IC4371, IC4370, IC4367, IC4366, IC4365, IC4363, IC4362, IC4361, IC4360, IC4359, IC4357, IC4356, IC4328, IC4326, IC4324, IC4323, IC4322, IC4258, IC4256, IC4255, IC4254, IC4253, IC4252, IC4251, IC4242, IC4241, IC4238, IC4236, IC4235, IC4234, IC4230, IC4229, IC4228, IC4227, IC4218, IC4217, IC4212, IC4211, IC4210, IC4209, IC4208, IC4207, IC4175, IC4153, IC4152, IC4151, IC4150, IC4149, IC4148, IC4147, IC4146, IC4129, IC4128, IC4100, IC4099, IC4098, IC4097, IC4096, IC4083, IC4081, IC4037, IC4036, IC4035, IC4034, IC4033, IC4015, IC4014, IC4013, IC4012, IC4006, IC4002, IC3891, IC3889, IC3886, IC3885, IC3884, IC3874, IC3873, IC3872, IC3871, IC3870, IC3869, IC3868, IC3867, IC3866, IC3864, IC3863, IC3862, IC3861, IC3860, IC3859, IC3834, IC3833, IC3832, IC3831, IC3830, IC3829, IC3828, IC3818, IC3817, IC3816, IC3815, IC3814, IC3813, IC3782, IC3781, IC3778, IC3777, IC3724, IC3717, IC3709, IC3708, IC3707, IC3706, IC3703, IC3701, IC3702, IC3700, IC3699, IC3698, IC3697, IC3696, IC3673, IC3672, IC3671, IC3669, IC3668, IC3667, IC3657, IC3659, IC3495, IC3493, IC3492, IC3491, IC3489, IC3488, IC3487, IC3486, IC3485, IC3477, IC3484, IC3472, IC3471, IC3470, IC3469, IC3468, IC3467, IC3466, IC3463, IC3462, IC3461, IC3460, IC3459, IC3458, IC3332, IC3331, IC3330, IC3329, IC3323, IC3319, IC3313, IC3328, IC3327, IC3324, IC3322, IC3321, IC3318, IC3317, IC3316, IC3315, IC3314, IC3311, IC3310, IC3305, IC3304, IC3303, IC3300, IC3299, IC3298, IC3297, IC3296, IC3292, IC3291, IC3290, IC3289, IC3288, IC3287, IC3286, IC3183, IC3181, IC3180, IC3179, IC3178, IC3149, IC3148, IC3147, IC3146, IC3145, IC3143, IC3142, IC3134, IC3133, IC3101, IC3100, IC3097, IC3096, IC3095, IC3070, IC3069, IC3068, IC3067, IC3054, IC3053, IC3052, IC3051, IC3022, IC3021, IC3020, IC3019, IC3018, IC3017, IC3016, IC3015, IC2997, IC2996, IC2988, IC2987, IC2985, IC2984, IC2964, IC2963, IC2962, IC2961, IC2960, IC2878, IC2877, IC2876, IC2875, IC2874, IC2873, IC2862, IC2859, IC2858, IC2856, IC2855, IC2838, IC2837, IC2836, IC2835, IC2830, IC2829, IC2826, IC2825, IC2824, IC2823, IC2767, IC2766, IC2763, IC2758, IC2757, IC2752, IC2751, IC2712, IC2710, IC2709, IC2708, IC2679, IC2678, IC2670, IC2669, IC2668, IC2659, IC2658, IC2657, IC2656, IC2655, IC2654, IC2653, IC2652, IC2610, IC2609, IC2606, IC2560, IC2534, IC2512, IC2491, IC2494, IC2490, IC2486, IC2485, IC2484, IC2483, IC2481, IC2475, IC2474, IC2473, IC2472, IC2470, IC2469, IC2441, IC2414, IC2413, IC2412, IC2411, IC2332, IC2330, IC2329, IC2327, IC2326, IC2325, IC2268, IC2267, IC2266, IC2244, IC2243, IC2242, IC2241, IC2240, IC2239, IC2236, IC2235, IC2234, IC2233, IC2232, IC2231, IC2220, IC2207, IC2206, IC2205, IC2204, IC2179, IC2178, IC2174, IC2173, IC2172, IC2171, IC2102, IC2101, IC2100, IC2099, IC2098, IC2097, IC2096, IC2095, IC2039, IC2038, IC2006, IC2005, IC1978, IC1977, IC1976, IC1975, IC1974, IC1973, IC1972, IC1971, IC1908, IC1907, IC1905, IC1904, IC1903, IC1902, IC1901, IC1886, IC1881, IC1780, IC1775, IC1874, IC1872, IC1871, IC1870, IC1826, IC1825, IC1824, IC1823, IC1822, IC1821, IC1768, IC1767, IC1766, IC1765, IC1764, IC1763, IC1761, IC1727, IC1726, IC1723, IC1722, IC1720, IC1700, IC1699, IC1685, IC1684, IC1676, IC1653, IC1592, IC1591, IC1590, IC1588, IC1585, IC1584, IC1580, IC1579, IC1578, IC1549, IC1548, IC1547, IC1546, IC1525, IC1524, IC1523, IC1522, IC1490, IC1488, IC1415, IC1413, IC1397, IC1396, IC1395, IC1393, IC1386, IC1384, IC1383, IC1381, IC1350, IC1349, IC1347, IC1344, IC1343, IC1341, IC1340, IC1304, IC1302, IC1301, IC1288, IC1276, IC1275, IC1265, IC1217. 6. Product Code: 0042-0000-IN; GTIN: 00813502011418; Serial Numbers pending correction as of 09/16/2025: IC7411, IC7409, IC7408, IC7080, IC7079, IC6478, IC6477, IC6476, IC6254, IC6253, IC6252, IC6139. Serial Numbers corrected as of 09/16/2025: IC7410, IC6475. 7. Product Code: 0042-0000-JP; GTIN: 00813502010428; Serial Numbers pending correction as of 09/16/2025: IC5515. Serial Numbers corrected as of 09/16/2025: IC8281, IC8279, IC8278, IC8277, IC8276, IC8084, IC8083, IC8082, IC8081, IC8080, IC8079, IC8078, IC8077, IC8076, IC8054, IC8053, IC8051, IC8050, IC8049, IC8048, IC8047, IC8046, IC7985, IC7984, IC7983, IC7982, IC7981, IC7980, IC7979, IC7978, IC7977, IC7976, IC7935, IC7934, IC7933, IC7929, IC7927, IC7926, IC7905, IC7903, IC7902, IC7901, IC7900, IC7899, IC7898, IC7897, IC7896, IC7853, IC7852, IC7846, IC7815, IC7814, IC7813, IC7812, IC7811, IC7808, IC7806, IC7785, IC7784, IC7783, IC7782, IC7779, IC7755, IC7754, IC7753, IC7752, IC7751, IC7750, IC7749, IC7673, IC7672, IC7612, IC7611, IC7610, IC7609, IC7608, IC7607, IC7606, IC7594, IC7593, IC7451, IC7450, IC7440, IC7439, IC7435, IC7434, IC7433, IC7431, IC7430, IC7429, IC7427, IC7426, IC7425, IC7424, IC7423, IC7422, IC7420, IC7417, IC7416, IC7415, IC7414, IC7413, IC7412, IC7387, IC7386, IC7385, IC7384, IC7383, IC7382, IC7381, IC7380, IC7379, IC7377, IC7376, IC7295, IC7294, IC7293, IC7291, IC7257, IC7256, IC7105, IC7104, IC7103, IC7102, IC7091, IC7090, IC7089, IC7085, IC7084, IC7083, IC7082, IC7081, IC7068, IC7067, IC7066, IC7065, IC7064, IC7063, IC7062, IC7061, IC7060, IC7059, IC7058, IC6985, IC7035, IC7034, IC7033, IC7031, IC7029, IC6888, IC6887, IC6886, IC6885, IC6883, IC6882, IC6863, IC6862, IC6861, IC6860, IC6859, IC6858, IC6857, IC6856, IC6855, IC6752, IC6751, IC6750, IC6749, IC6748, IC6747, IC6746, IC6745, IC6662, IC6661, IC6660, IC6659, IC6658, IC6657, IC6656, IC6654, IC6653, IC6652, IC6651, IC6650, IC6642, IC6610, IC6607, IC6606, IC6605, IC6519, IC6556, IC6555, IC6554, IC6553, IC6552, IC6551, IC6550, IC6549, IC6548, IC6533, IC6492, IC6491, IC6490, IC6452, IC6430, IC6429, IC6468, IC6467, IC6466, IC6451, IC6442, IC6407, IC6406, IC6405, IC6389, IC6388, IC6316, IC6315, IC6314, IC6313, IC6312, IC6311, IC6310, IC6309, IC6308, IC6307, IC6306, IC6212, IC6211, IC6210, IC6204, IC6203, IC6090, IC6089, IC6088, IC6087, IC6086, IC6085, IC6084, IC6049, IC6048, IC6047, IC6046, IC5938, IC5937, IC5936, IC5935, IC5930, IC5868, IC5867, IC5866, IC5865, IC5864, IC5863, IC5862, IC5861, IC5860, IC5820, IC5819, IC5735, IC5734, IC5733, IC5732, IC5731, IC57...

Label field

Details supplied by the agency

Lot, code or applicability

1. Product Code: 1000432; GTIN: 00813502013030; Serial Numbers pending correction as of 09/16/2025: IC11239, IC11238, IC10837, IC10497, IC10493, IC10338, IC10362. Serial Numbers corrected as of 09/16/2025: IC11404, IC11401, IC11400, IC11399, IC10827, IC11237, IC11236, IC11232, IC11231, IC11230, IC11227, IC11210, IC11182, IC11153, IC11145, IC11143, IC10854, IC10851, IC10849, IC10703, IC10300, IC10786, IC10785, IC10784, IC10762, IC10755, IC10727, IC10689, IC10672, IC10652, IC10651, IC10650, IC10631, IC10588, IC10586, IC10585, IC10584, IC10518, IC10517, IC10496, IC10494, IC10492, IC10483, IC10365, IC10364, IC10353, IC10170, IC11619, IC11616, IC11611, IC11600. 2. Product Code: 1000201; GTIN: 00813502010442; Serial Numbers pending correction as of 09/16/2025: IC9821, IC9820, IC9819, IC9818, IC9817, IC9816, IC9815, IC9814, IC9813, IC9641, IC9637, IC9636, IC9635, IC9633, IC9632, IC9629. 3. Product Code: 0042-0000-AU; GTIN: 00813502010886; Serial Numbers pending correction as of 09/16/2025: IC7289, IC7288, IC6531, IC5677, IC5521, IC5238, IC5237, IC5236. Serial Numbers corrected as of 09/16/2025: IC7850, IC7849, IC7290, IC7287, IC6530, IC6529, IC6528, IC6527, IC6526, IC5836, IC5752, IC5622, IC5525, IC5524, IC5523, IC5522, IC5341, IC5217, IC5216. 4. Product Code: 0042-0000-CA; GTIN: 00813502011272; Serial Numbers pending correction as of 09/16/2025: IC4944, IC2370, IC2369, IC2034, IC2032, IC1715, IC1665, IC1572, IC1544, IC1480. Serial Numbers corrected as of 09/16/2025: IC9416, IC9415, IC9414, IC9413, IC8283, IC7716, IC7695, IC7694, IC6636, IC6635, IC6634, IC6633, IC6083, IC6082, IC5824, IC5821, IC5680, IC5034, IC5050, IC4945, IC3803, IC3802, IC3662, IC3661, IC2687, IC2686, IC2035, IC2033, IC1913, IC1912, IC1911, IC1791, IC1790, IC1769, IC1664, IC1598, IC1595, IC1543, IC1481, IC1346, IC1324. 5. Product Code: 0042-0000-EU; GTIN: 00813502011289; Serial Numbers pending correction as of 09/16/2025: IC7686, IC7675, IC7584, IC7583, IC7582, IC7581, IC7454, IC7453, IC7452, IC7406, IC7395, IC6880, IC6581, IC6580, IC6578, IC6577, IC6510, IC6489, IC6434, IC6387, IC6386, IC6375, IC6374, IC6373, IC6372, IC6371, IC6370, IC6331, IC6294, IC6293, IC6216, IC6214, IC6165, IC6164, IC5780, IC5779, IC5777, IC5775, IC5687, IC5558, IC5520, IC5492, IC5467, IC5466, IC5465, IC5357, IC5356, IC5251, IC5055, IC4682, IC4681, IC4562, IC4507, IC4358, IC4329, IC4325, IC4257, IC4240, IC4069, IC4068, IC4054, IC3890, IC3888, IC3887, IC3812, IC3783, IC3780, IC3776, IC3720, IC3719, IC3718, IC3705, IC3704, IC3670, IC3666, IC3665, IC3664, IC3663, IC3660, IC3658, IC3656, IC3490, IC3309, IC3308, IC3307, IC3306, IC3302, IC3301, IC3144, IC3132, IC3131, IC3130, IC3129, IC3128, IC3127, IC3102, IC3099, IC3098, IC3050, IC3049, IC2989, IC2861, IC2860, IC2828, IC2827, IC2765, IC2677, IC2676, IC2607, IC2471, IC2479, IC2478, IC2477, IC2476, IC2557, IC2556, IC2444, IC2443, IC2442, IC2222, IC2219, IC2175, IC1876, IC1725, IC1724, IC1678, IC1677, IC1594, IC1577, IC1416, IC1411, IC1345, IC1305, IC1285, IC1284, IC1283, IC1280. Serial Numbers corrected as of 09/16/2025: IC7809, IC7748, IC7721, IC7720, IC7719, IC7718, IC7717, IC7693, IC7692, IC7691, IC7690, IC7689, IC7688, IC7687, IC7674, IC7667, IC7666, IC7655, IC7654, IC7653, IC7652, IC7651, IC7650, IC7649, IC7648, IC7647, IC7646, IC7615, IC7614, IC7613, IC7580, IC7579, IC7578, IC7577, IC7576, IC7421, IC7455, IC7407, IC7394, IC7393, IC7392, IC7390, IC7389, IC7388, IC7378, IC7286, IC7265, IC7264, IC7263, IC7262, IC7261, IC7260, IC7259, IC7258, IC7100, IC7099, IC7098, IC7097, IC7096, IC7095, IC7094, IC7093, IC7092, IC7087, IC7078, IC7077, IC7076, IC7075, IC6879, IC6878, IC6877, IC6876, IC6845, IC6843, IC6814, IC6813, IC6812, IC6810, IC6809, IC6808, IC6807, IC6806, IC6805, IC6804, IC6742, IC6741, IC6740, IC6739, IC6738, IC6728, IC6717, IC6716, IC6715, IC6714, IC6713, IC6712, IC6711, IC6710, IC6709, IC6708, IC6707, IC6706, IC6695, IC6694, IC6693, IC6692, IC6691, IC6690, IC6689, IC6688, IC6595, IC6594, IC6593, IC6592, IC6591, IC6590, IC6589, IC6588, IC6587, IC6582, IC6579, IC6536, IC6535, IC6534, IC6488, IC6487, IC6469, IC6449, IC6443, IC6441, IC6440, IC6439, IC6437, IC6436, IC6435, IC6432, IC6431, IC6270, IC6205, IC6275, IC6274, IC6272, IC6236, IC6225, IC6224, IC6223, IC6151, IC6150, IC6149, IC6147, IC6081, IC6078, IC6064, IC5818, IC5817, IC5781, IC5756, IC5755, IC5754, IC5722, IC5717, IC5716, IC5715, IC5714, IC5611, IC5688, IC5686, IC5685, IC5684, IC5683, IC5682, IC5681, IC5560, IC5559, IC5519, IC5518, IC5517, IC5496, IC5495, IC5494, IC5493, IC5491, IC5490, IC5488, IC5487, IC5477, IC5476, IC5464, IC5463, IC5462, IC5461, IC5460, IC5443, IC5442, IC5441, IC5440, IC5436, IC5435, IC5434, IC5433, IC5422, IC5421, IC5331, IC5392, IC5391, IC5252, IC5195, IC5194, IC5193, IC5212, IC5210, IC5178, IC5177, IC5176, IC5175, IC5174, IC5173, IC5171, IC5169, IC5088, IC5087, IC5086, IC5075, IC5053, IC5051, IC5057, IC5049, IC5048, IC5047, IC5046, IC5009, IC5008, IC5007, IC4973, IC4988, IC4987, IC4986, IC4984, IC4934, IC4933, IC4932, IC4931, IC4930, IC4929, IC4928, IC4850, IC4917, IC4916, IC4915, IC4914, IC4913, IC4846, IC4845, IC4840, IC4839, IC4837, IC4836, IC4835, IC4834, IC4833, IC4824, IC4823, IC4822, IC4821, IC4820, IC4819, IC4818, IC4817, IC4816, IC4815, IC4797, IC4796, IC4795, IC4794, IC4793, IC4792, IC4791, IC4790, IC4781, IC4763, IC4762, IC4761, IC4760, IC4759, IC4758, IC4757, IC4748, IC4738, IC4737, IC4736, IC4735, IC4734, IC4733, IC4724, IC4723, IC4729, IC4728, IC4727, IC4725, IC4680, IC4679, IC4678, IC4677, IC4658, IC4657, IC4656, IC4649, IC4647, IC4646, IC4645, IC4636, IC4635, IC4634, IC4633, IC4632, IC4631, IC4630, IC4585, IC4629, IC4627, IC4626, IC4624, IC4623, IC4614, IC4613, IC4612, IC4611, IC4610, IC4609, IC4598, IC4597, IC4595, IC4594, IC4569, IC4568, IC4567, IC4566, IC4565, IC4557, IC4564, IC4563, IC4561, IC4560, IC4559, IC4508, IC4506, IC4505, IC4501, IC4500, IC4471, IC4470, IC4469, IC4468, IC4467, IC4466, IC4465, IC4464, IC4446, IC4445, IC4444, IC4443, IC4442, IC4371, IC4370, IC4367, IC4366, IC4365, IC4363, IC4362, IC4361, IC4360, IC4359, IC4357, IC4356, IC4328, IC4326, IC4324, IC4323, IC4322, IC4258, IC4256, IC4255, IC4254, IC4253, IC4252, IC4251, IC4242, IC4241, IC4238, IC4236, IC4235, IC4234, IC4230, IC4229, IC4228, IC4227, IC4218, IC4217, IC4212, IC4211, IC4210, IC4209, IC4208, IC4207, IC4175, IC4153, IC4152, IC4151, IC4150, IC4149, IC4148, IC4147, IC4146, IC4129, IC4128, IC4100, IC4099, IC4098, IC4097, IC4096, IC4083, IC4081, IC4037, IC4036, IC4035, IC4034, IC4033, IC4015, IC4014, IC4013, IC4012, IC4006, IC4002, IC3891, IC3889, IC3886, IC3885, IC3884, IC3874, IC3873, IC3872, IC3871, IC3870, IC3869, IC3868, IC3867, IC3866, IC3864, IC3863, IC3862, IC3861, IC3860, IC3859, IC3834, IC3833, IC3832, IC3831, IC3830, IC3829, IC3828, IC3818, IC3817, IC3816, IC3815, IC3814, IC3813, IC3782, IC3781, IC3778, IC3777, IC3724, IC3717, IC3709, IC3708, IC3707, IC3706, IC3703, IC3701, IC3702, IC3700, IC3699, IC3698, IC3697, IC3696, IC3673, IC3672, IC3671, IC3669, IC3668, IC3667, IC3657, IC3659, IC3495, IC3493, IC3492, IC3491, IC3489, IC3488, IC3487, IC3486, IC3485, IC3477, IC3484, IC3472, IC3471, IC3470, IC3469, IC3468, IC3467, IC3466, IC3463, IC3462, IC3461, IC3460, IC3459, IC3458, IC3332, IC3331, IC3330, IC3329, IC3323, IC3319, IC3313, IC3328, IC3327, IC3324, IC3322, IC3321, IC3318, IC3317, IC3316, IC3315, IC3314, IC3311, IC3310, IC3305, IC3304, IC3303, IC3300, IC3299, IC3298, IC3297, IC3296, IC3292, IC3291, IC3290, IC3289, IC3288, IC3287, IC3286, IC3183, IC3181, IC3180, IC3179, IC3178, IC3149, IC3148, IC3147, IC3146, IC3145, IC3143, IC3142, IC3134, IC3133, IC3101, IC3100, IC3097, IC3096, IC3095, IC3070, IC3069, IC3068, IC3067, IC3054, IC3053, IC3052, IC3051, IC3022, IC3021, IC3020, IC3019, IC3018, IC3017, IC3016, IC3015, IC2997, IC2996, IC2988, IC2987, IC2985, IC2984, IC2964, IC2963, IC2962, IC2961, IC2960, IC2878, IC2877, IC2876, IC2875, IC2874, IC2873, IC2862, IC2859, IC2858, IC2856, IC2855, IC2838, IC2837, IC2836, IC2835, IC2830, IC2829, IC2826, IC2825, IC2824, IC2823, IC2767, IC2766, IC2763, IC2758, IC2757, IC2752, IC2751, IC2712, IC2710, IC2709, IC2708, IC2679, IC2678, IC2670, IC2669, IC2668, IC2659, IC2658, IC2657, IC2656, IC2655, IC2654, IC2653, IC2652, IC2610, IC2609, IC2606, IC2560, IC2534, IC2512, IC2491, IC2494, IC2490, IC2486, IC2485, IC2484, IC2483, IC2481, IC2475, IC2474, IC2473, IC2472, IC2470, IC2469, IC2441, IC2414, IC2413, IC2412, IC2411, IC2332, IC2330, IC2329, IC2327, IC2326, IC2325, IC2268, IC2267, IC2266, IC2244, IC2243, IC2242, IC2241, IC2240, IC2239, IC2236, IC2235, IC2234, IC2233, IC2232, IC2231, IC2220, IC2207, IC2206, IC2205, IC2204, IC2179, IC2178, IC2174, IC2173, IC2172, IC2171, IC2102, IC2101, IC2100, IC2099, IC2098, IC2097, IC2096, IC2095, IC2039, IC2038, IC2006, IC2005, IC1978, IC1977, IC1976, IC1975, IC1974, IC1973, IC1972, IC1971, IC1908, IC1907, IC1905, IC1904, IC1903, IC1902, IC1901, IC1886, IC1881, IC1780, IC1775, IC1874, IC1872, IC1871, IC1870, IC1826, IC1825, IC1824, IC1823, IC1822, IC1821, IC1768, IC1767, IC1766, IC1765, IC1764, IC1763, IC1761, IC1727, IC1726, IC1723, IC1722, IC1720, IC1700, IC1699, IC1685, IC1684, IC1676, IC1653, IC1592, IC1591, IC1590, IC1588, IC1585, IC1584, IC1580, IC1579, IC1578, IC1549, IC1548, IC1547, IC1546, IC1525, IC1524, IC1523, IC1522, IC1490, IC1488, IC1415, IC1413, IC1397, IC1396, IC1395, IC1393, IC1386, IC1384, IC1383, IC1381, IC1350, IC1349, IC1347, IC1344, IC1343, IC1341, IC1340, IC1304, IC1302, IC1301, IC1288, IC1276, IC1275, IC1265, IC1217. 6. Product Code: 0042-0000-IN; GTIN: 00813502011418; Serial Numbers pending correction as of 09/16/2025: IC7411, IC7409, IC7408, IC7080, IC7079, IC6478, IC6477, IC6476, IC6254, IC6253, IC6252, IC6139. Serial Numbers corrected as of 09/16/2025: IC7410, IC6475. 7. Product Code: 0042-0000-JP; GTIN: 00813502010428; Serial Numbers pending correction as of 09/16/2025: IC5515. Serial Numbers corrected as of 09/16/2025: IC8281, IC8279, IC8278, IC8277, IC8276, IC8084, IC8083, IC8082, IC8081, IC8080, IC8079, IC8078, IC8077, IC8076, IC8054, IC8053, IC8051, IC8050, IC8049, IC8048, IC8047, IC8046, IC7985, IC7984, IC7983, IC7982, IC7981, IC7980, IC7979, IC7978, IC7977, IC7976, IC7935, IC7934, IC7933, IC7929, IC7927, IC7926, IC7905, IC7903, IC7902, IC7901, IC7900, IC7899, IC7898, IC7897, IC7896, IC7853, IC7852, IC7846, IC7815, IC7814, IC7813, IC7812, IC7811, IC7808, IC7806, IC7785, IC7784, IC7783, IC7782, IC7779, IC7755, IC7754, IC7753, IC7752, IC7751, IC7750, IC7749, IC7673, IC7672, IC7612, IC7611, IC7610, IC7609, IC7608, IC7607, IC7606, IC7594, IC7593, IC7451, IC7450, IC7440, IC7439, IC7435, IC7434, IC7433, IC7431, IC7430, IC7429, IC7427, IC7426, IC7425, IC7424, IC7423, IC7422, IC7420, IC7417, IC7416, IC7415, IC7414, IC7413, IC7412, IC7387, IC7386, IC7385, IC7384, IC7383, IC7382, IC7381, IC7380, IC7379, IC7377, IC7376, IC7295, IC7294, IC7293, IC7291, IC7257, IC7256, IC7105, IC7104, IC7103, IC7102, IC7091, IC7090, IC7089, IC7085, IC7084, IC7083, IC7082, IC7081, IC7068, IC7067, IC7066, IC7065, IC7064, IC7063, IC7062, IC7061, IC7060, IC7059, IC7058, IC6985, IC7035, IC7034, IC7033, IC7031, IC7029, IC6888, IC6887, IC6886, IC6885, IC6883, IC6882, IC6863, IC6862, IC6861, IC6860, IC6859, IC6858, IC6857, IC6856, IC6855, IC6752, IC6751, IC6750, IC6749, IC6748, IC6747, IC6746, IC6745, IC6662, IC6661, IC6660, IC6659, IC6658, IC6657, IC6656, IC6654, IC6653, IC6652, IC6651, IC6650, IC6642, IC6610, IC6607, IC6606, IC6605, IC6519, IC6556, IC6555, IC6554, IC6553, IC6552, IC6551, IC6550, IC6549, IC6548, IC6533, IC6492, IC6491, IC6490, IC6452, IC6430, IC6429, IC6468, IC6467, IC6466, IC6451, IC6442, IC6407, IC6406, IC6405, IC6389, IC6388, IC6316, IC6315, IC6314, IC6313, IC6312, IC6311, IC6310, IC6309, IC6308, IC6307, IC6306, IC6212, IC6211, IC6210, IC6204, IC6203, IC6090, IC6089, IC6088, IC6087, IC6086, IC6085, IC6084, IC6049, IC6048, IC6047, IC6046, IC5938, IC5937, IC5936, IC5935, IC5930, IC5868, IC5867, IC5866, IC5865, IC5864, IC5863, IC5862, IC5861, IC5860, IC5820, IC5819, IC5735, IC5734, IC5733, IC5732, IC5731, IC57...

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, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland.

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: Oct 29, 2025
Recall initiation date: Sep 16, 2025
Center classification date: Oct 17, 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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