AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
AROA Biosurgery is recalling Endoform Dermal Template 2x2 units due to a potential for pouch seal failure.
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 the source text does not report any illnesses or injuries, indicating a theoretical risk of harm.
Plain-English summary
AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 2x2, SKU 529311. The product is a sterile, single-use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.
The recall is being conducted due to a potential for pouch seal failure. The affected lot numbers are EDT-7H06, EDT-7L01, EDT-7L03, and EDT-8A01.
The product was distributed nationwide in the United States. Healthcare providers and consumers should stop using the affected units and contact AROA Biosurgery for further instructions.
The recalled product
- Product
- Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
- Manufacturer
- AROA BIOSURGERY
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 8,853
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 numbers: EDT-7H06 EDT-7L01 EDT-7L03 EDT-8A01
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by AROA BIOSURGERY 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 3 products in this recall →Related recalls
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