# FDA recall Z-1975-2025

> **MicroAire Surgical Instruments, LLC** · Class II · device recall initiated 2025-05-07.

## 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 for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-1975-2025
- **Recalling firm:** MicroAire Surgical Instruments, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-07
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Charlottesville, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1975-2025

## Citation

> AI Analytics. FDA recall Z-1975-2025. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-1975-2025. Source: US FDA. Licensed CC0.

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