Gentell Hydrogel Ag Wound Dressing Recalled for Registration Issues
Gentell, Inc. is recalling Gentell Hydrogel Ag wound dressings 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 1/5 (Low).
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 rather than a product defect or safety hazard, which aligns with the rubric criteria for Low severity.
Plain-English summary
Gentell, Inc. is recalling 6,395 units of Gentell Hydrogel Ag 4oz. Tube wound dressings. The recall was initiated after an FDA audit discovered that the product was not properly registered with the FDA.
The affected product 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 product was distributed worldwide, including in the United States and various international locations.
Consumers and healthcare professionals should stop using the product and contact Gentell, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Gentell Hydrogel Ag 4oz. Tube, model no. - Product Usage: Under the care of a healthcare professional, Gentell Hydrogel Ag Silver Antimicrobial Wound Dressing is indicated for partial and full thickness wounds, including pressure ulcers, venous stasis ulcers, diabetic ulcers…
- Manufacturer
- Gentell, Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 6,395
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
Same manufacturer · Gentell, Inc
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