Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Recalled by Inspire Medical Systems Inc. Due to Incorrect use-by date on the device registration/patient file...
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 II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
Quantity: 93 devices
Why Was This Recalled?
Incorrect use-by date on the device registration/patient file labels.
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