Brand Name: Inspire Medical Systems — Class II medical device recall Z-2516-2026
Ongoing recall by Inspire Medical Systems Inc., reported 2026-06-24, distributed nationwide. Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from dat
| Recall number | Z-2516-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inspire Medical Systems Inc., Golden Valley, MN, United States |
| Recall initiated | 2026-05-11 |
| Classified | 2026-06-18 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK |
| Quantity | 10 impacted |
| Reason classes | labeling, specification failure |
| UPC / GTIN / UDI-DI | 10810098650295, 10855728005793 |
| Serial numbers | D53393, D61104, D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959 |
| Model numbers | 4063, 900-013-001, 900-013-003 |
Product
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2516-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.