Multi-Mode Stimulator recall
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Why was Multi-Mode Stimulator recalled?
The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00860000178303, Serial Numbers: 181102627, 180101759, 180302368, 180603258, 180101748, 180603502, 160700386, 170305821, 170305701, 180603845, SZ151100022, 180603489, SZ160801811, 180603829, 151100395, 180101912, 181102643, 160800430, 180603799, 160800489, 181102635, 181102714, 180302357, 181102642, 161202284, 160800483, 180603914, 180101917, 161202293, 161202285, 181102649, 160107765, 180603065, 180603924, SZ160502068, 180603841, 180603864, 160800092, 180603059, 160800417, SZ160700097, 170305806, 160800493, 161202287, 181102646, 181102789, 180101911, SZ151100005, 180603839, SZ151100017, 181102803, 180101738, 160800429, 180302376, 180603041, 160800508, 180603958, 180603965, 180603822, 180603244, 181102787, 180603824, 180603828, 160800420, 180603855, 180302345, 180603057, 181102794, 181102636, 181102790, 180603066, 180302348, 181102795, 170305704, 161202288, 1801102713, 180603821, 180603921, 7141000961, 180603261, 160800091, 181102710, 161202286, SZ160502080, 160800093, 180603843, 181102709, 160800439, 180603927, 170305819, 180603867, 170305716, 180302366, 181102800, 181102798, 180603941, 170305815, 180603817, 180603865, 160800066, 180603493, 180603505, 181102791, 181102653, SZ150900502, 180603061, 180603260, 181102647, 180603053, 180603814, 180603067, 180603496, 180603255, SZ160700100, 180603495, 160800485, 181102804, 151100129, 181102698, 180603498, 181102690, 180603801, 160800498, 160800083, 181102693, 180603058, 180603962, 161202274, SZ151100032, 181102281, 160800418, 180603967, 180603787, 180603506, 161202282, 180603050, 180101920, 181102637, 180603253, 170305813, 181102628, 180603849, 180101916, 160800427, 180603832, 160107764, 180603866, 180603503, 181102638, 180603851, 180603064, 180603262, 180603242, 180603923, 181102703, 181102720, 170305798, 170305800, 180302351, 180603500, SZ160801822, 181102634, 180302373, 180603051, 160800486, SZ150900361, 170305807, 180603942, 161202291, 180603811, 160107762, 181102813, 160700121, 160800506, 170305804, 180101900, 180302370, 160800504, 160800505, 180603818, 181102692, 180101739, 161202298, 181102633, 180603809, 180603823, 180603870, 180603263, 161202290, 160800419, 180603908, 170305816, 161202275, 180603256, SZ160801801, SZ150900357, SZ150900367, 170305721, 180603836, 170305707, 170305728, 180603848, 180603922, 180302353, 180603497, 180101924, 170305794, 170305818, 180603857, 180101894, 160107746, 180603054, 180302362, 160800490, 180603871, 180101752, 180603055, 180302365, 160800497, 180603802, 181102719, 170305715, 160800495, 170305699, 160800069, 181102625, 180603943, 180603838, 180101922, 181102655, 180603790, 170305812, 181102274, 180603952, SZ150900400, 180603778, 160800425, 180101741, 181102788, 180603834, 180603264, 180101762, 160800075, 180603813, 160107747, 160800068, 160800441, 180101750, 181102629, 160800079, 181102283, 170305811, 170305822, 180603957, 181102792, 180603062, 180603243, 180603069, 170305802, 160800436, 180603785, 180101753, 180101923, 170305697, 181102785, 180603064, 170305702, 160800496, SZ160801803, 180603507, 160800094, 160700398, 160800481, 181102689, 160800487, 180603517, 160800492, 170305714, 180603490, 181102651, 180302371, 160800072, 180603511, 170305801, 180603816, 180603045, 180603919, 180603963, SZ151100151, 180603060, 160800424, 180603257, SZ160700098, 160800434, 180603847, 181102808, 180603826, 160800439, 180603960, 160800432, 160800510, 170305810, 180603868, 180603800, 180603869, 161202273, 180603860, SZ150900359, 180603807, SZ151100001, 180603806, 180101763, 181102699, 180101907, 180603931, 160800421, 181102640, 180603861, 181102717, 180302347, 160800428, 180603844, 170305727, 170305705, 180603930, 180603951, 160700407, 160800423, 170305706, 170305803, 180302352, 170305795, 180603046, 181102707, 180302369, 180603794, 160800080, 170305719, 180603792, 180603240, 181102797, 160800065, 181102701, 170305698, 181102814, 180603049, 180603510, 180603825, 180302367, 181102718, 180603494, SZ150900377, 180603044, 181102626, 181102716, 160800442, SZ160801808, SZ160502058, 180101921, 180603929, 170305809, 160800512, 180603246, 180101757, 180603803, 170305720, 160800096, 170305797, 180603254, 181102811, 180603513, 180101901, 180603831, SZ150900353, 180603910, SZ160801810, SZ160700399, 160800067, 180603048, 160800509, 160107752, 180603842, 170305799, 170305708, SZ160700386, 180603872, 180101747, 181102632, 160800070, 180603786, 180101736, 181102816, 180101902, 181102712, 180603072, 181102799, 160800484, 180603798, 160801816, 180603846, 180603820, 170305817, 180603926, 180302360, 150900416, 181102695, 181102812, 160800482, 181102645, 160800502, 180603797, 180603514, 180603966, 160800076, 160800488, 180302346, 170305823, 180603499, 180302350, 181102648, 180603955, 170305814, 180101893, 181102704, 180603376, 180603518, 180603043, 180603859, 180603252, 180603375, 180603830, 180603856, 180603840, 180603949, 180302349, 180603783, 180101734, 181102631, 180603516, 170305808, 160800426, 170305712, 180603808, 180603259, SZ150900354, 181102639, 180603835, 160800438, 170305820, 180603804, 180603070, 181102644, 181102802, 180603850, 181102697, 181102786, 180603784, 180101905, 160800494, 181102650, 180302359, 180603964, 160107772, 180603833, 180603912, 180101895, 181102700, 170305805, 180603515, 181102641, 180603862, 180101897, 180603944
- Product
- Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
- Recalling firm
- Liberty Medical Solutions, LLC
- Quantity
- 473 units
- Distribution
- US Nationwide distribution in the states of CT, FL, NC, NJ, NY.
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)