# FDA recall Z-1908-2020

> **Gentell, Inc** · Class II · device recall initiated 2020-03-26.

## Product

Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model  Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts and abrasions

## Reason for recall

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

## Distribution

Worldwide distribution - US Nationwide distributions and the country of South Africa.

## Key facts

- **Recall number:** Z-1908-2020
- **Recalling firm:** Gentell, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-03-26
- **Report date:** 2020-05-13

- **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-1908-2020

## Citation

> AI Analytics. FDA recall Z-1908-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-1908-2020. Source: US FDA. Licensed CC0.

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