FDA Device recall Z-1909-2020
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Num…
- FDA Device
- Class II
- ongoing
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Num… by Gentell, citing during an FDA audit, it was discovered that the product was not properly registered with FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1909-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-03-26 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Gentell |
| Distribution | US |
Product
Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - 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
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Identifiers
| code_info | Lot Numbers: 1133718 1135318 1101019 1102819 1110619 1116219 1118219 1121119 1122119 1123519 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1909-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.