Class II — Inspire Medical Systems Inc.
| Recalling firm | Inspire Medical Systems Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. |
| Product | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. |
| Quantity | 457 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore. |
| Initiated | 2024-07-31 |
| Classified | 2024-10-09 |
| Recall number | Z-0041-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Inspire Medical Systems Inc. (Z-0041-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95230/
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