Class II — AROA BIOSURGERY
| Recalling firm | Aroa Biosurgery Ltd |
|---|---|
| Registered facility | Aroa Biosurgery Ltd (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential for pouch seal failure |
| 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. |
| Quantity | 8,853 total boxes |
| Distribution | US Nationwide Distribution |
| Initiated | 2018-11-27 |
| Classified | 2018-11-02 |
| Terminated | 2019-04-09 |
| Recall number | Z-0377-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AROA BIOSURGERY (Z-0377-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81161/
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