FDA recall, , Moderate risk
Inspire Respiratory Sensing and Stimulation Lead
The Inspire Respiratory Sensing Lead has an incorrect Use By Date, which may lead to unplanned revision surgery.
Summary by Recall Canary from the FDA notice
What happened
Inspire Medical Systems Inc. of Golden Valley, Minnesota, recalled the Inspire stimulation Lead (Model 4063) and the Inspire Respiratory Sensing Lead (Model 4340) because the products are labeled with an incorrect Use By Date, extending beyond the validated three-year shelf life from the date of manufacture.
Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. The recall began May 11, 2026, and was added to the FDA's Enforcement Report on June 18, 2026. Distribution was worldwide, including the US Nationwide and Hong Kong.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Inspire Medical Systems, Inc. Inspire Respiratory Sensing Lead
- UDI-DI
- 10855728005946
- 10810098650301
- Model/Catalog number
- 4340
Inspire Medical Systems, Inc. Inspire stimulation Lead
- UDI-DI
- 10855728005793
- 10810098650295
- Model/Catalog number
- 4063
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Hong Kong.
- Company
- Inspire Medical Systems Inc.Golden Valley, Minnesota
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98990
- Recall numbers
- Z-2515-2026 to Z-2516-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
