Inspire recall: Labeling Error

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?

Model 4063. UDI-DI: 10855728005793. Part Number: 900-013-001. Serial Numbers: T52648, T52644, T52642, T52640, T52635, T52630, T52634, T52615, T52611, T52654, T52655, T52607, T52604, T52609, T52603, T52595, T52597, T52616, T52594, T52591, T52590, T52592, T52612, T52588, T52625, T52579, T52566, T52561, T52522, T52523, T48445, T48424, T48403, T48388, T48357, T48352, T48345, T48340, T48331, T48332, T48333, T48288, T11952, T11955, T48282, T48265, T48255, T48253, T48254, T48217, T48188, T48184, T48167, T48189, T48213, T48166, T48161, T48153, T48149, T48144, T47959, T47947, T47940, T48435, T47936, T47820, T47818, T47805, T47785, T47772, T47770, T47761, T47748, T47747, T47733, T47731, T47708, T47709, T47683, T47660, T47767, T47768, T47630, T47617, T47615, T47614, T47490, T47473, T47924, T47459, T47447, T47417, T48170, T47400, T47389, T45700, T47824, T47368, T47364, T47354, T43971, T48314, T47349, T47356, T47415, T47342, T47303, T47211, T47440, T46791, T47196, T47186, T47187, T47198, T47200, T43079, T47149, T47144, T47167, T47138, T48262, T47132, T47116, T47206, T47067, T46826, T47674, T46821, T46820, T46802, T46799, T46798, T46797, T46760, T46742, T46714, T46700, T46596, T46592, T46588, T46562, T46563, T46559, T46526, T46353, T46336, T46313, T52538, T46300, T52515, T52520, T46295, T45740, T45736, T45720, T45701, T45697, T45679, T45420, T45405, T45375, T45372, T45366, T45358, T45347, T45333, T45132, T44982, T44965, T44933, T44931, T44911, T44754, T44698, T43947, T43938, T43918, T43910, T43902, T43898, T43881, T43873, T43799, T43795, T43784, T43763, T43754, T43741, T43716, T43732, T43704, T43516, T43506, T43361, T43362, T43363, T43328, T43338, T43326, T43322, T43323, T43101, T43115, T43117, T43299, T43291, T43264, T43249, T43244, T43238, T43236, T43135, T43108, T43096, T30899, T30916, T47710, T47711, T47712, T43093, T43064, T42831, T42814, T42805, T43273, T42794, T42789, T42781, T42760, T42574, T42592, T42593, T42568, T42323, T42122, T47758, T47786, T41973, T52549, T41953, T41954, T41944, T41926, T41927, T41921, T41577, T46721, T46723, T48356, T48360, T10211, T10287, T41920, T41918, T41824, T41780, T43761, T41759, T48215, T41724, T41697, T29941, T29951, T44953, T42298, T42299, T41671, T41649, T47826, T41547, T47312, T41434, T41425, T41670, T41707, T41420, T44681, T47136, T41296, T43889, T43969, T41259, T41277, T41249, T41244, T41195, T42319, T41063, T40951, T41040, T40983, T40959, T40957, T40917, T40849, T40846, T40762, T40763, T40725, T40573, T40708, T40560, T29971, T40110, T40100, T40095, T40043, T38150, T40014, T39976, T39936, T39904, T39889, T39845, T39781, T39827, T39828, T39779, T39769, T39705, T39693, T46365, T39689, T39969, T39670, T37168, T39651, T39625, T39585, T39529, T39518, T39448, T43296, T39443, T39372, T39374, T48363, T48364, T39351, T39326, T42812, T45718, T39313, T39285, T37755, T39933, T39281, T39290, T39267, T39268, T39270, T39271, T39143, T39096, T40101, T39085, T38193, T38203, T39523, T52610, T39081, T39076, T39077, T38984, T42103, T38945, T38450, T38434, T38197, T52651, T52652, T38185, T39530, T38180, T38133, T43455, T38103, T38151, T37879, T37845, T37831, T37830, T37824, T37813, T37800, T36459, T45354, T37780, T40096, T38205, T38206, T37779, T37725, T40124, T37705, T37634, T37589, T37461, T37280, T44750, T37251, T37231, T37216, T43744, T46725, T37200, T37193, T37153, T37058, T36679, T36657, T36614, T36528, T36512, T36513, T36514, T36516, T36517, T36504, T36501, T36458, T36463, T36376, T30914, T30912, T30847, T30851, T30852, T29965, T29964, T29955, T29954, T29953, T29936, T47918, T29935, T27236, T15775, T11827, T11589, T11422, T11297, T11214, T11215, T11614, T11201, T11202, T11213, T11419, T10102, T10131, T10089, T10098, T10099, T10101, T11165, T11166.

Product

Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

Recalling firm

Inspire Medical Systems Inc.

Quantity

457 units

Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.

Recall date

October 16, 2024

Classification

Class II

Status

Ongoing

Agency

FDA (device)