# FDA recall Z-2222-2019

> **MicroAire Surgical Instruments, LLC** · Class II · device recall initiated 2019-06-26.

## Product

SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

## Reason for recall

There was a higher than normal incidence rate of the blade not retracting when tightening.

## Distribution

The products were distributed to the following US states:  CA, CT, FL, GA, IA, IL, IN, MD, MI, MN, MS, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.    The products were distributed to the following foreign countries:  Australia, Czech Republic, France, Germany, and Taiwan.

## Key facts

- **Recall number:** Z-2222-2019
- **Recalling firm:** MicroAire Surgical Instruments, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-26
- **Report date:** 2019-08-14
- **Termination date:** 2020-04-29

- **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-2222-2019

## Citation

> AI Analytics. FDA recall Z-2222-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2222-2019. Source: US FDA. Licensed CC0.

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