Medical Device Recall: 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: Sma
MicroAire Surgical Instruments, LLC · May 7, 2025
Reason for Recall
Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.
Product Description
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);
Distribution
Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.
States Affected
NATIONWIDE
Quantity Affected
1,451 eaches
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1975-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.