Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Num
- Recall date
- 2026-06-24
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Recommended action
What to do
10 impacted units
Product description
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.