Amerx Recalls Amerigel Saturated Gauze Dressing Due to Formulation Deviation
Amerx Health Care Corp. is recalling 21,108 units of Amerigel Saturated Gauze Dressing due to a formulation deviation. The products were distributed nationwide and internationally.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any specific injuries or illnesses, and the hazard is described generally as a 'formulation deviation' without specific details on the risk.
Plain-English summary
Amerx Health Care Corp. is recalling 21,108 units of Amerigel Saturated Gauze Dressing, a wound management product. The recall was initiated due to a formulation deviation. The affected products are Model # A5002 and include Lot #s: 05368, 05345, 09282, 10295, 12201, 12303, 12322, 12328, 13100, 13115, and 13180.
The recalled products were distributed worldwide, including nationwide in the United States and internationally to Canada, England, Africa, and Australia. The source text does not specify the exact nature of the formulation deviation or report any specific illnesses or injuries associated with the use of these products.
Consumers and healthcare providers should stop using the affected lots and contact Amerx Health Care Corp. for further instructions or a refund.
The recalled product
- Product
- Amerigel Saturated Gauze Dressing Wound management
- Manufacturer
- Amerx Health Care Corp.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 21,108
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 (12)
- Model # A5002
- Lot #s: 05368
- 05345
- 09282
- 10295
- 12201
- 12303
- 12322
- 12328
- 13100
- 13115
- 13180
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.
See all 4 products in this recall →Related recalls
Same manufacturer · Amerx Health Care Corp.
See all →- ModerateAmerx Recalls Amerigel Hydrogel Wound Dressing Due to Zinc Acetate Specification Failure
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- ModerateAmerx Recalls Amerigel Hydrogel Gauze Dressing for Nonapproved Sterile Labeling
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- HighAmerx Health Care Recalls Amerigel Hydrogel Wound Dressing Due to Formulation Deviation
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- ModerateAmerx Health Care Recalls Amerigel Daily Dressing Packets Due to Formulation Deviation
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- ModerateAmerx Health Care Recalls Amerigel Post-op Surgical Kits Due to Formulation Deviation
FDA (Devices) · 2014-12-10
Same hazard · formulation deviation
See all →- ModerateClotting time reagent recalled after lots were made with double preservative
FDA (Devices) · 2025-12-24
Similar recalls
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FDA (Devices) · 2015-06-24
- ModerateAmerx Recalls Amergel Hydrogel Gauze Dressing for Unapproved Labeling Claims
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- ModerateAmerx Recalls Amergel Wound Dressing Due to Unapproved Labeling Claims
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- ModerateAmerx Recalls Amerigel Post-Op Surgical Kits for Unapproved Labeling Claims
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- ModerateAmerx Recalls Amerigel Daily Dressing for Unapproved Labeling Claims
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