Gentell Hydrogel Ag Gauze Recalled for FDA Registration Failure
Gentell, Inc. is recalling 53,134 units of Gentell Hydrogel Ag 2x2 gauze because the product was not properly registered with the FDA.
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 classified as FDA Class II and involves a documentation/registration issue rather than a direct physical hazard or reported illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Gentell, Inc. is recalling 53,134 units of Gentell Hydrogel Ag 2x2, model no GEN-11220. This medical device is indicated for use under the care of a healthcare professional for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, and skin tears.
The recall was initiated after an FDA audit discovered that the product was not properly registered with the FDA. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including nationwide distribution in the United States and in several international countries. No specific illnesses or injuries have been reported in the source text. Consumers and healthcare providers should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Gentell Hydrogel Ag 2x2, model no GEN-11220 - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Saturated Gauze is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second deg
- Manufacturer
- Gentell, Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 53,134
Distribution
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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