FDA Device recall Z-1910-2020
Gentell Honey Hydrogel Hydrogel 4oz
- FDA Device
- Class II
- ongoing
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Gentell Honey Hydrogel Hydrogel 4oz 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-1910-2020 |
| 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 Hydrogel 4oz. Tube. Wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11340 - 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 1105819 1107119 1110619 1118219 1121119 1122119 1130319 |
|---|
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-1910-2020%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.