# FDA recall Z-0470-2021

> **Micro-Tech Usa** · Class II · device recall initiated 2020-10-05.

## Product

Elastic Traction Device, 11mm Lower. UPN: ER56041  Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.

## Reason for recall

FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.

## Distribution

US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.

## Key facts

- **Recall number:** Z-0470-2021
- **Recalling firm:** Micro-Tech Usa
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-05
- **Report date:** 2020-11-25
- **Termination date:** 2021-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0470-2021

## Citation

> AI Analytics. FDA recall Z-0470-2021. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-0470-2021. Source: US FDA. Licensed CC0.

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