AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 2x2 due to a potential pouch seal failure that could compromise sterility.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the potential for seal failure poses a risk of harm (loss of sterility) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AROA Biosurgery is recalling 8,853 boxes of Endoform Dermal Template 2x2, SKU 529312. 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 lots are EDT-7I01, EDT-7K01, and EDT-7L05. These products were distributed nationwide in the United States. A seal failure could potentially compromise the sterile integrity of the device.
Healthcare providers and facilities should stop using the affected product and contact AROA Biosurgery for further instructions or a return.
The recalled product
- Product
- Endoform Dermal Template 2x2, SKU 529312 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
- 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-7I01 EDT-7K01 EDT-7L05
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
Same manufacturer · AROA BIOSURGERY
See all →- HighAROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
FDA (Devices) · 2018-11-14
- ModerateAROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure
FDA (Devices) · 2018-11-14
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