The Recall Desk
HighFDA (Devices)·Z-1975-2025·Announced 2025-06-18

SmartRelease Onyx Blade Assembly Surgical System Recalled

MicroAire Surgical Instruments is recalling the SmartRelease ESTR Onyx Blade Assembly due to a potential risk that the blade can unintentionally cut tissue before the user deploys it.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a surgical device presenting a risk of tissue cutting injury. The source states no reported illnesses or injuries, but the device poses a direct risk of harm during use, which places it in the High category per the rubric.

Plain-English summary

MicroAire Surgical Instruments, LLC is recalling the SmartRelease ESTR (Endoscopic Soft Tissue Release System) Onyx Blade Assembly, also known as the ECTR (Endoscopic Carpal Tunnel Release) System Onyx Blade Assembly. The product is identified by catalog numbers 83030-1 (single pack) and 83030-6 (six pack), with specific lot numbers identified by the manufacturer.

The recall is due to the potential that the blade can unintentionally cut tissue prior to the user deploying the blade. This poses a risk of unintended injury during endoscopic surgical procedures.

The affected product has been distributed worldwide, including US Nationwide distribution as well as to Denmark and the United Kingdom. A total of 1,451 units have been distributed. Users of this device should contact MicroAire Surgical Instruments, LLC for further instructions regarding the recalled product.

The recalled product

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
Manufacturer
MicroAire Surgical Instruments, LLC
Category
Medical Device — Surgical / Endoscopic Instrument
Hazard
  • unintended-blade-deployment
  • cutting-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category