# FDA recall Z-0641-2021

> **GA HEALTH COMPANY LIMITED** · Class II · device recall initiated 2020-11-03.

## Product

STOPCON Disposable Endoscope Valves Set-Single Use   Valves Olympus R (Air-Water-/Suction)    DISTRIBUTED BY: KEY SURGICAL  8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA    Product Code: EN10229.2

## Reason for recall

Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure

## Distribution

US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.

## Key facts

- **Recall number:** Z-0641-2021
- **Recalling firm:** GA HEALTH COMPANY LIMITED
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-03
- **Report date:** 2020-12-30
- **Termination date:** 2021-09-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Shatin N.T., N/A, Hong Kong SAR

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0641-2021

## Citation

> AI Analytics. FDA recall Z-0641-2021. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0641-2021. Source: US FDA. Licensed CC0.

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