Kova Laboratories Recalls Amerigel Wound Dressing Due to Manufacturing Concerns
Kova Laboratories is recalling 3 drums of Amerigel Wound Dressing because the product may not have been manufactured according to validated protocols and CGMP.
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 classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential manufacturing deviation (lack of validated protocol/CGMP) rather than a confirmed high-risk pathogen or structural defect, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Kova Laboratories, Inc. is recalling 3 drums of Amerigel Wound Dressing (55 gallons/drum), Lot #3WD05. The recall is being conducted because the product may not have been manufactured pursuant to a validated process protocol and Current Good Manufacturing Practices (CGMP).
The affected product was distributed in the states of Florida and New Jersey. This recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers who have this product should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Amerigel Wound Dressing 55 gallons/drum
- Manufacturer
- Kova Laboratories, Inc.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #3WD05.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Kova Laboratories, 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 2 products in this recall →Related recalls
Same manufacturer · Kova Laboratories, Inc.
See all →- ModerateAmerigel Wound Dressing Recalled for Manufacturing Process Concerns
FDA (Devices) · 2014-07-16
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