Endoform Dermal Template 4x5 — Class II medical device recall Z-0379-2019
Terminated recall by AROA BIOSURGERY, reported 2018-11-14, distributed nationwide. Potential for pouch seal failure
| Recall number | Z-0379-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AROA BIOSURGERY, Airport Oaks, New Zealand |
| Recall initiated | 2018-11-27 |
| Classified | 2018-11-02 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2019-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 8,853 boxes |
| Reason classes | packaging |
| Lot numbers | EDT-7I02, EDT-7L02 |
Product
Endoform Dermal Template 4x5, SKU 529313 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.
Reason for recall
Potential for pouch seal failure
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0379-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.