MicroAire Surgical Instruments, LLC recalls Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (End

Recalled June 18, 2025 · FDA recall Z-1975-2025 · MicroAire Surgical Instruments

Hazard

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. · FDA Class II

Units

1,451 eaches

Sold at

Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.

Description

Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

Product

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);

Manufacturer(s)

MicroAire Surgical Instruments, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →