# FDA recall Z-1623-2020

> **Gentell, Inc** · Class II · device recall initiated 2020-02-27.

## Product

Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns and skin tears. It provides a moist wound environment for healing.

## Reason for recall

During an FDA audit, it was discovered that the product was not properly registered with FDA.

## Distribution

Worldwide distribution  US Nationwide distribution in the states of AL, CA, FL, IA, IL, KY, MA, MI, MN, NC, NJ, NY, OH, OK, PA, Puerto Rico, RI, SC, TN, TX, WI and countries of Panama, South Africa, Bahrain, Spain, Mexico, Costa Rica, Romania.

## Key facts

- **Recall number:** Z-1623-2020
- **Recalling firm:** Gentell, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-02-27
- **Report date:** 2020-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bristol, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1623-2020

## Citation

> AI Analytics. FDA recall Z-1623-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1623-2020. Source: US FDA. Licensed CC0.

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