CLASS II ONGOING Device recall · Reported 16 Oct 2024 · FDA Enforcement Report

Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled

Inspire Medical Systems is recalling Inspire Model 4063 Stimulation Lead, component of the Inspire Upper, distributed nationwide in the US. The recall was initiated on 31 Jul 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled457 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0041-2025
FDA event ID: 95230
Recalling firm: Inspire Medical Systems, Golden Valley, MN
Classification: Class II
Status: Ongoing
Recall initiated: 31 Jul 2024
FDA classified: 9 Oct 2024
Reported: 16 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Masks, Gloves & PPE

Timeline

31 Jul 2024	Recall initiated by company
9 Oct 2024	Classified by FDA	+70 days
16 Oct 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Is Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled?

Yes. Inspire Medical Systems recalled Inspire Model 4063 Stimulation Lead, component of the Inspire Upper on 31 Jul 2024. The recall is Class II and its status is Ongoing. Recall number Z-0041-2025.

Why was it recalled?

Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

Which lots 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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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