Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system) Recalled by MicroAire Surgical Instruments, LLC Due to Potential that the blade can unintentionally cut tissue...
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
Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);
Quantity: 1,451 eaches
Why Was This Recalled?
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
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