Lower risk Medical device recall · FDA · Published July 31, 2024

Inspire Model 4340 Respiratory Lead Recall: Labeling Error Risk

Inspire Medical Systems recalls Model 4340 Respiratory Sensing Lead due to labeling error between box serial and actual serial numbers. Affected units have specific serial numbers listed. No action needed per recall details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0040-2025Medical device Inspire Medical Systems ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmInspire Medical Systems Inc.5500 Wayzata Blvd Ste 1600 · Golden Valley, MN 55416-1237

✎ GovInfoNow plain-language explainer

Inspire Medical Systems is recalling Model 4340 Respiratory Sensing Leads because there's a mismatch between the serial number on the box and the actual serial number of the lead. This labeling error could lead to incorrect identification of the device, but it does not pose a safety risk to users. Read more at govinfonow.com/recall/54374-inspire-model-4340-respiratory-lead-recall-labeling-error-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54374-inspire-model-4340-respiratory-lead-recall-labeling-error-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0040-2025

Cite this page

“Inspire Model 4340 Respiratory Lead Recall: Labeling Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54374-inspire-model-4340-respiratory-lead-recall-labeling-error-risk. Based on FDA recall #Z-0040-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0040-2025%22&limit=1).

Inspire Medical Systems Inc. recalled Inspire Model 4340 Respiratory Sensing Leads due to a labeling error where the shelf box serial number does not match the lead's serial number, according to the FDA. The agency announced the voluntary Class II recall on July 31, 2024. Owners should contact the company for a replacement.

How to tell if you have it

Brand: Inspire Medical Systems
Product: Inspire Model 4340 Respiratory Sensing Lead (component of Inspire Upper Airway Stimulation system)
Model Number: Model 4340
UDI-DI: 10855728005946
Part Number: 900-014-00
Serial Numbers: D59544, D59550, D59543, D59541, D59542, D59528, D59526, D59534, D59521, D59477, D59519, D59515, D59516, D59489, D59514, D59512, D59510, D59509, D59547, D59549, D59505, D59506, D59504, D59503, D59502, D59529, D59497, D59494, D59490, D59485, D59486, D56077, D56072, D56064, D56060, D56059, D56055, D56038, D56082, D56035, D56044, D56031, D56032, D56033, D56034, D56040, D56046, D56030, D56036, D56053, D56054, D56058, D55284, D48681, D48668, D48661, D48655, D48650, D48410, D46477, D46478, D43687, D43688, D43700, D48014, D48007, D47994, D47991, D47983, D47964, D47963, D47958, D47940, D45763, D47939, D45768, D47913, D47228, D47903, D47896, D47897, D47909, D47910, D47951, D45706, D45721, D45724, D47877, D47872, D47879, D47880, D47691, D47670, D47654, D47243, D47240, D47220, D47187, D47181, D47176, D47177, D47191, D47192, D47175, D47169, D47163, D47164, D47142, D47131, D47926, D47102, D47013, D47006, D46990, D46966, D46955, D46854, D46855, D46847, D46846, D46835, D46804, D46797, D46784, D47202, D46699, D46700, D46664, D46566, D46567, D46561, D46535, D46532, D46527, D46528, D46529, D46525, D46526, D46463, D46451, D45962, D45949, D45947, D45777, D45773, D45745, D45708, D44687, D44685, D44677, D44675, D26997
Quantity: 152 units
Distribution: US Nationwide, Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore

The hazard

The recall involves a labeling error where the serial number on the shelf box does not match the serial number of the respiratory sensing lead inside, according to the FDA. This mismatch could lead to confusion regarding the specific component's identity and tracking.

Context

GovInfoNow's records show Inspire Medical Systems Inc. has issued three other recalls since June 12, 2018. On May 16, 2024, the company recalled Inspire Model 3028 Pulse Generators due to electrical leakage risks. Other recent recalls of similar products include Medline TRACH TUBE KIT Recall (July 10, 2026), Omnicell i.v.Station Label Stock Recall (March 25, 2026), and Baxter Healthcare PRO+ 40" MRS SURFACE Mattress Recall (August 18, 2026).

How to tell if you have this one

Check if your Inspire Model 4340 Respiratory Sensing Lead has a serial number from the list provided in the recall (e.g., D59544, D59550, etc.). The product is part of the Inspire UAS system.

Brand
Inspire Medical Systems
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.

Recall number	Product, codes & lots	Quantity
Z-0040-2025	Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.; Model 4340. UDI-DI: 10855728005946. Part Number: 900-014-00. Serial Numbers: D59544, D59550, D59543, D59541, D59542, D59528, D59526, D59534, D59521, D59477, D59519, D59515, D59516, D59489, D59514, D59512, D59510, D59509, D59547, D59549, D59505, D59506, D59504, D59503, D59502, D59529, D59497, D59494, D59490, D59485, D59486, D56077, D56072, D56064, D56060, D56059, D56055, D56038, D56082, D56035, D56044, D56031, D56032, D56033, D56034, D56040, D56046, D56030, D56036, D56053, D56054, D56058, D55284, D48681, D48668, D48661, D48655, D48650, D48410, D46477, D46478, D43687, D43688, D43700, D48014, D48007, D47994, D47991, D47983, D47964, D47963, D47958, D47940, D45763, D47939, D45768, D47913, D47228, D47903, D47896, D47897, D47909, D47910, D47951, D45706, D45721, D45724, D47877, D47872, D47879, D47880, D47691, D47670, D47654, D47243, D47240, D47220, D47187, D47181, D47176, D47177, D47191, D47192, D47175, D47169, D47163, D47164, D47142, D47131, D47926, D47102, D47013, D47006, D46990, D46966, D46955, D46854, D46855, D46847, D46846, D46835, D46804, D46797, D46784, D47202, D46699, D46700, D46664, D46566, D46567, D46561, D46535, D46532, D46527, D46528, D46529, D46525, D46526, D46463, D46451, D45962, D45949, D45947, D45777, D45773, D45745, D45708, D44687, D44685, D44677, D44675, D26997.	152 units
Z-0041-2025	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.; 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.	457 units

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Verify if your lead has a serial number from the list of affected serial numbers provided in the recall.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

Jul 31, 2024Firm started the recall
Oct 9, 2024FDA classified it Class II
Oct 16, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything with this lead?

No action is required. The recall is informational only and does not affect device safety.

What serial numbers are affected?

The affected serial numbers are listed in the recall: D59544, D59550, D59543, and many others as detailed in the record.

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Link to this recall

<a href="https://govinfonow.com/recall/54374-inspire-model-4340-respiratory-lead-recall-labeling-error-risk">Inspire Model 4340 Respiratory Lead Recall: Labeling Error Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0040-2025 (July 31, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0040-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.