Inspire Medical Systems Inc. recalls
Every recall we track for Inspire Medical Systems Inc. — 6 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Inspire Medical Systems Inc. peaked in 2024 (3); 6 since 2017.
All FDA recall records for Inspire Medical Systems Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 1 | 2 | 0 | 3 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 2 | 0 | 2 |
What to do if you have a recalled Inspire Medical Systems Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Inspire Medical Systems Inc. recalls
4 shown- Lower riskMedical device
Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product
Inspire Medical Systems recalls Model 4063 stimulation leads with incorrect Use By Dates that may lead to unplanned surgery. Affected units have specific serial numbers and were sold in the US. Contact for remedy details.
Inspire Medical SystemsMay 11, 2026 - Lower riskMedical device
Inspire Medical Systems Inc. recalls Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Inspire Medical Systems recalls Model 4340 Respiratory Sensing Lead due to labeling error between box serial and actual serial numbers. Affected units have specific serial numbers listed. No action needed per recall details.
Inspire Medical SystemsJul 31, 2024 - Use cautionMedical device
Inspire Medical Systems Inc. recalls Inspire Model 3028, IV Implantable Pulse Generator
Inspire Medical Systems recalls Model 3028 IV Implantable Pulse Generator due to potential electrical leakage causing system malfunction and requiring revision surgery. Affected units have specific serial numbers in the US and Europe.
Inspire Medical SystemsMay 16, 2024 - Lower riskMedical device
Inspire Medical Systems Inc. recalls Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product
Inspire Medical Systems recalls Inspire II Model 3024 IPGs due to incorrect use-by dates (2018-01-14) on patient file labels. Check your device registration.
Inspire Medical SystemsJun 12, 2018
Inspire Medical Systems Inc. recall questions
How many recalls has Inspire Medical Systems Inc. had?
6 recalls from Inspire Medical Systems Inc. are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Inspire Medical Systems Inc. recall?
Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product, dated May 11, 2026. Every Inspire Medical Systems Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Inspire Medical Systems Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Inspire Medical Systems Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.