# FDA recall Z-0094-2021

> **Genicon, Inc.** · Class II · device recall initiated 2020-08-25.

## Product

Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site

## Reason for recall

The product design incorporating a motor driven impeller pump powered by one 9V alkaline battery inside the hand-piece did not receive proper premarket clearance from US FDA and lacks a 510(k).

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, IA, IL, IN, MA, MI, MO, NC, OH, TN, VA, WA, WI and the countries of ECUADOR, HONG KONG, QATAR, SAUDI ARABIA, UAE (Dubai),  JORDAN,  KUWAIT, SOUTH AFRICA.

## Key facts

- **Recall number:** Z-0094-2021
- **Recalling firm:** Genicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-08-25
- **Report date:** 2020-10-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Winter Park, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0094-2021

## Citation

> AI Analytics. FDA recall Z-0094-2021. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0094-2021. Source: US FDA. Licensed CC0.

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