Recall Z-1975-2025— MicroAire Surgical Instruments, LLC

Name: FDA recall Z-1975-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-07

Class II · Ongoing

Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2025-05-07. It names one FDA 510(k) clearance: K223406. 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);. Reason: Potential that the blade can unintentionally cut tissue prior to the user deploying the blade..

Recalling firm: MicroAire Surgical Instruments, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-05-07
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K223406 — SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments·cleared 2023-02-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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);

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.