Gentell Honey Hydrogel Recalled for FDA Registration Deficiency
Gentell, Inc. is recalling Gentell Honey Hydrogel because the product was not properly registered with the FDA, as discovered during an audit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is due to a documentation and registration issue (failure to register with FDA) rather than a direct safety hazard like contamination or defect, which aligns with the 'Moderate' criteria for minor labeling or documentation errors.
Plain-English summary
Gentell, Inc. is recalling 4,419 units of Gentell Honey Hydrogel, a wound dressing containing hydrogel and 100% Leptospermum honey. The product is available in 4oz tubes under Model Number GEN-11340. It is intended for use on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers, first and second-degree burns, post-surgical incisions, cuts, and abrasions.
The recall was initiated after an FDA audit revealed that the product was not properly registered with the FDA. The affected units were distributed worldwide, including nationwide in the United States and in South Africa. The specific lot numbers involved are 1133718, 1135318, 1101019, 1105819, 1107119, 1110619, 1118219, 1121119, 1122119, and 1130319.
Consumers and healthcare providers who have this product should stop using it and contact Gentell, Inc. for further instructions or a refund. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- 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 seco
- Manufacturer
- Gentell, Inc
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 4,419
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Gentell, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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