Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Inspire Model 4340 Respiratory Sensing Lead Recalled by Inspire Medical Systems Inc. Due to Labeling error with a mismatch between the shelf...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Inspire Medical Systems Inc. directly.
Affected Products
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Quantity: 152 units
Why Was This Recalled?
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Inspire Medical Systems Inc.
Inspire Medical Systems Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report