Amerx Recalls Amergel Wound Dressing Due to Unapproved Labeling Claims
Amerx Health Care Corp. is recalling Amergel Wound Dressing Maximum Strength because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.
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 and involves minor labeling errors (unapproved claims) without reported injuries or illnesses, fitting the 'Moderate' severity criteria for low-risk contamination or labeling issues.
Plain-English summary
Amerx Health Care Corp. is recalling Amergel Wound Dressing Maximum Strength, catalog number A2001, due to labeling violations. The product is a wound management device that was distributed nationwide in the United States, including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, as well as in Canada, England, Africa, and Australia.
The recall was initiated because the product labeling includes claims that the dressing is antimicrobial and performs autolytic debridement. These claims were not approved by the FDA. The affected lot codes are 3WD02, 3WD03, 3WD04, and 3WD05. A total of 382,620 units are involved in this recall.
Consumers and healthcare providers should stop using the affected products and contact Amerx Health Care Corp. for instructions on how to return or dispose of the items. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
- Manufacturer
- Amerx Health Care Corp.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 382,620
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 (4)
- Lot codes: 3WD02
- 3WD03
- 3WD04
- and 3WD05
Distribution
Part of a larger recall action
This product is one of 4 recalled by Amerx Health Care Corp. 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.
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