# FDA recall Z-2005-2020

> **Genicon, Inc.** · Class II · device recall initiated 2018-06-27.

## Product

Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction.

## Reason for recall

Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of  IL, IN, MO,TN, and the country of Denmark.

## Key facts

- **Recall number:** Z-2005-2020
- **Recalling firm:** Genicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-06-27
- **Report date:** 2020-05-20

- **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-2005-2020

## Citation

> AI Analytics. FDA recall Z-2005-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2005-2020. Source: US FDA. Licensed CC0.

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