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

Recall date

May 7, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1975-2025

FDA classification

Class II

Brand / firm

MicroAire Surgical Instruments, LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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);