--- title: "Inspire Medical Systems Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Inspire Medical Systems Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/inspire-medical-systems-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Inspire Medical Systems Inc. recall records **5** reported ongoing 5 records in this archive. Latest source date May 11, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 11, 2026 FDA device enforcement ### [Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respi...](https://isitonrecall.com/recall/fda-device-z-2515-2026-brand-name-inspire-medical-systems-inc-product-name-inspire-respiratory-sensing-lead-model-catalog-n/) Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong. [Official source for Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Ca...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2515-2026%22) May 11, 2026 FDA device enforcement ### [Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is de...](https://isitonrecall.com/recall/fda-device-z-2516-2026-brand-name-inspire-medical-systems-inc-product-name-inspire-stimulation-lead-model-catalog-number-40/) Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong. [Official source for Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Nu...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2516-2026%22) Jul 31, 2024 FDA device enforcement ### [Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.](https://isitonrecall.com/recall/fda-device-z-0040-2025-inspire-model-4340-respiratory-sensing-lead-component-of-the-inspire-upper-airway-stimulation-uas-sy/) Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore. [Official source for Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (U...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0040-2025%22) Jul 31, 2024 FDA device enforcement ### [Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.](https://isitonrecall.com/recall/fda-device-z-0041-2025-inspire-model-4063-stimulation-lead-component-of-the-inspire-upper-airway-stimulation-uas-system/) Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore. [Official source for Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0041-2025%22) May 16, 2024 FDA device enforcement ### [Inspire Model 3028, IV Implantable Pulse Generator](https://isitonrecall.com/recall/fda-device-z-2159-2024-inspire-model-3028-iv-implantable-pulse-generator/) There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG, Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the country of Germany. [Official source for Inspire Model 3028, IV Implantable Pulse Generator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2159-2024%22) ## Reasons in these listed records - Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. - Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. - There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG, These examples come from this result page and are not a ranking of every recall reason. ## Checking Inspire Medical Systems Inc. ### Is there a recall on inspire medical systems inc. right now? This archive contains 5 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Inspire Medical Systems Inc.](https://isitonrecall.com/check/?q=Inspire%20Medical%20Systems%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)