Amerigel Wound Dressing Recalled for Manufacturing Process Concerns
Kova Laboratories is recalling Amerigel Wound Dressing 1 oz. tubes because they may not have been manufactured pursuant to a validated process protocol 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 explicitly states no illnesses or injuries have been reported and the hazard is related to manufacturing process validation rather than a specific high-risk pathogen or structural defect, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Kova Laboratories, Inc. is recalling 122,396 tubes of Amerigel Wound Dressing 1 oz. The affected lots are #3WD02, #3WD03, #3WD04, and #3WD05. The product was distributed in the states of Florida and New Jersey.
The recall was initiated because the product may not have been manufactured pursuant to a validated process protocol and Current Good Manufacturing Practice (CGMP). The source text does not report any specific illnesses, injuries, or deaths associated with the use of this product.
Consumers who have purchased Amerigel Wound Dressing 1 oz. tubes from the affected lots should stop using the product and contact Kova Laboratories, Inc. for further instructions or a refund.
The recalled product
- Product
- Amerigel Wound Dressing 1 oz. tube
- Manufacturer
- Kova Laboratories, Inc.
- Category
- Medical Device — Wound Care
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 (3)
- Lot #3WD02
- Lot #3WD03
- Lot #3WD04 and 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 →- ModerateKova Laboratories Recalls Amerigel Wound Dressing Due to Manufacturing Concerns
FDA (Devices) · 2014-07-16
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