Gentell Hydrogel Ag Gauze Recalled for FDA Registration Deficiency
Gentell, Inc. is recalling 20,025 units of Gentell Hydrogel Ag 4x4 gauze because the product was not properly registered with the FDA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 rather than a direct safety hazard or reported injury, fitting the criteria for a moderate severity recall.
Plain-English summary
Gentell, Inc. is recalling 20,025 units of Gentell Hydrogel Ag 4x4, model no. GEN-11420. This medical device is indicated 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 in the United States and several international countries. Consumers and healthcare professionals should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Gentell Hydrogel Ag 4x4, model no. GEN-11420 - 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…
- Manufacturer
- Gentell, Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 20,025
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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