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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93277

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 03, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Liberty Medical Solutions, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

Z-0506-2024
Recall number
Z-0506-2024
Initiated
November 03, 2023
Classification
Class II
Status
Ongoing
Quantity
473 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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

Distribution pattern

US Nationwide distribution in the states of CT, FL, NC, NJ, NY.