FDAClass IIDecember 13, 2023

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)
Open FDA enforcement record Latest recalls