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

Endoscopic Surgical Blade Assembly Recalled for Unintended Tissue Cutting Risk

MicroAire's SmartRelease ESTR Onyx Blade Assembly is being recalled because the blade can unintentionally cut tissue before the surgeon deploys it. Healthcare facilities should discontinue use of affected units.

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: FDA Class II medical device with demonstrated risk of unintended tissue cutting during surgical use. No illnesses or injuries reported. Meets criteria for high-risk products where injury has not yet been reported due to potential for significant harm in surgical context.

Plain-English summary

MicroAire Surgical Instruments, LLC is recalling the SmartRelease ESTR (Endoscopic Soft Tissue Release) system, also known as the ECTR (Endoscopic Carpal Tunnel Release) system Onyx Blade Assembly. The product is used in endoscopic surgical procedures to release soft tissue or perform carpal tunnel release.

The company has determined that the blade can unintentionally cut tissue prior to the surgeon deploying it. This unintended activation poses a risk of tissue damage during surgical procedures.

The recall affects 1,451 units distributed worldwide in the United States, Denmark, and the United Kingdom. Healthcare facilities using the affected SKU numbers (83030-1 single pack, 83030-6 six pack, and 83030-6-CE six pack) should immediately discontinue use and contact MicroAire Surgical Instruments, LLC for guidance on device replacement or return.

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 Instruments / Endoscopic
Hazard
  • unintended-cutting
  • device-malfunction

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