Inspire Model 4063 Stimulation Lead — Class II medical device recall Z-0041-2025
Ongoing recall by Inspire Medical Systems Inc., reported 2024-10-16, distributed nationwide. Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead pro
| Recall number | Z-0041-2025 |
|---|---|
| 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 | 2024-07-31 |
| Classified | 2024-10-09 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, GB, NL, SG |
| Quantity | 457 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10855728005793 |
| Serial numbers | T10089, T10098, T10099, T10101, T10102, T10131, T10211, T10287, T11165, T11166, T11201, T11202, T11213, T11214, T11215, T11297, T11419, T11422, T11589, T11614, T11827, T11952, T11955, T15775, T27236 and 432 more |
| Model numbers | 4063, 900-013-001 |
Product
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
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.
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-0041-2025. 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.