MicroAire Surgical Instruments, LLC: Medical Device Recall in 2025 - (Recall #: Z-1975-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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);

Product Classification:

Class II

Date Initiated: May 7, 2025

Date Posted: June 18, 2025

Recall Number: Z-1975-2025

Event ID: 96868

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,451 eaches

Code Information:

Catalog (SKU) Numbers:(1) 83030-1 (single pack), (2) 83030-6 (six pack) and (3) 83030-6-CE (six pack OUS only); UDI-DI: (1) 00847399017246 (single pack), (2&3) 00847399015860 (six pack); Lot Numbers: (1) 104842032025, (2) 104841032025, 104873032025, 104885042025, 104902042025, (3) 104865032025;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated