Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound… — Class II medical device recall Z-1908-2020
Ongoing recall by Gentell, Inc, reported 2020-05-13, distributed nationwide. During an FDA audit, it was discovered that the product was not properly registered with FDA.
| Recall number | Z-1908-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gentell, Inc, Bristol, PA, United States |
| Recall initiated | 2020-03-26 |
| Classified | 2020-05-06 |
| Reported by FDA | 2020-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | ZA |
| Quantity | 22,439 |
| Lot numbers | 1101019, 1102819, 1105819, 1107119, 1110619, 1116219, 1118219, 1121119, 1122119, 1123519, 1126319, 1130319, 1133718, 1135318 |
| Model numbers | GEN-11430 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1908-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.