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.
What this means for you
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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