Inspire Medical Systems Inc.
Inspire Medical Systems Inc. appears in FDA public data with 6 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2516-2026, Class II) was initiated on May 11, 2026. Its most recent FDA inspection ended on Dec 19, 2025 (Voluntary Action Indicated (VAI)).
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Summary
- Total Recalls
- 6 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2516-2026 | Class II | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Num | May 11, 2026 |
| Z-2515-2026 | Class II | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Cat | May 11, 2026 |
| Z-0040-2025 | Class II | Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) | Jul 31, 2024 |
| Z-0041-2025 | Class II | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. | Jul 31, 2024 |
| Z-2159-2024 | Class I | Inspire Model 3028, IV Implantable Pulse Generator | May 16, 2024 |
| Z-2969-2018 | Class II | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #9 | Jun 12, 2018 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 19, 2025 | Golden Valley, MN | Devices | Voluntary Action Indicated (VAI) | 3030499299 |
| May 10, 2024 | Golden Valley, MN | Devices | Voluntary Action Indicated (VAI) | 3007666314 |
| Sep 16, 2021 | Golden Valley, MN | Devices | No Action Indicated (NAI) | 3007666314 |
| Jun 22, 2018 | Golden Valley, MN | Devices | Voluntary Action Indicated (VAI) | 3007666314 |
| Apr 29, 2015 | Golden Valley, MN | Devices | No Action Indicated (NAI) | 3007666314 |
| Sep 26, 2013 | Golden Valley, MN | Devices | Voluntary Action Indicated (VAI) | 3007666314 |