Inspire II Model 3024 Implantable Pulse Generator — Class II medical device recall Z-2969-2018
Terminated recall by Inspire Medical Systems Inc., reported 2018-09-12, distributed nationwide. Incorrect use-by date on the device registration/patient file labels.
| Recall number | Z-2969-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inspire Medical Systems Inc., Maple Grove, MN, United States |
| Recall initiated | 2018-06-12 |
| Classified | 2018-09-04 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2019-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 93 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10855728005434 |
| Model numbers | 3024, 900-003-020 |
| Expiration dates | 2018-01-14 |
Product
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
Reason for recall
Incorrect use-by date on the device registration/patient file labels.
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-2969-2018. 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.