Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure
Gentell, Inc. is recalling 22,439 units of Gentell Honey Hydrogel 4"x4" Saturated Gauze because the product was not properly registered with the FDA.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and registration issue (failure to register with FDA) rather than a product defect or contamination, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Gentell, Inc. is recalling 22,439 units of Gentell Honey Hydrogel 4"x4" Saturated Gauze, Model Number GEN-11430. This hydrating wound dressing contains hydrogel and 100% Leptospermum honey and 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 discovered 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 recall covers specific lot numbers: 1133718, 1135318, 1101019, 1102819, 1105819, 1107119, 1110619, 1116219, 1118219, 1121119, 1122119, 1123519, and 1126319, 1130319.
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- 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,
- Manufacturer
- Gentell, Inc
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 22,439
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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