Inspire recalls
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Inspire and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-24FDA-DeviceClass IIInspire stimulation lead recalled for incorrect expiration date
Inspire Medical Systems' Model 4063 stimulation leads are labeled with expiration dates that extend beyond their actual three-year shelf life. If a lead is used after its true expiration date, the material may degrade and could require unplanned revision surgery. A small number of units (10 total) have been affected worldwide.
- 2026-06-24FDA-DeviceClass IIInspire Respiratory Sensing Lead recalled for incorrect expiration date
Inspire Medical Systems' Respiratory Sensing Lead (Model 4340) was labeled with expiration dates that extend beyond the validated three-year shelf life. If the device is used after its actual expiration date, the material may degrade and could require unplanned revision surgery.
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