Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MicroAire SmartRelease Endoscopic System Recalled by MicroAire Surgical Instruments, LLC Due to The Instructions for Use (IFU) is incorrect with...
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 MicroAire Surgical Instruments, LLC directly.
Affected Products
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic carpal tunnel syndrome). Preoperative x-rays of the wrist, including a carpal tunnel view, are recommended to aid in the diagnosis of associated pathology (i.e., calcific tendonitis, fracture of the hook of the hamate). This device is indicated for releasing the transverse carpal ligament (flexor retinaculum).
Quantity: 2009
Why Was This Recalled?
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MicroAire Surgical Instruments, LLC
MicroAire Surgical Instruments, LLC has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report