CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report
Endoform Dermal Template recalled by Aroa Biosurgery
Aroa Biosurgery is recalling Endoform Dermal Template, distributed nationwide in the US. The recall was initiated on 27 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0378-2019
- FDA event ID
- 81161
- Recalling firm
- Aroa Biosurgery, Airport Oaks
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2018
- FDA classified
- 2 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 2 Nov 2018 | Classified by FDA | |
| 14 Nov 2018 | Published in enforcement report | +12 days |
| 27 Nov 2018 | Recall initiated by company | +13 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for pouch seal failure
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Endoform Dermal Template recalled?
Yes. Aroa Biosurgery recalled Endoform Dermal Template on 27 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-0378-2019.
Why was it recalled?
Potential for pouch seal failure
Which lots are affected?
Lot numbers: EDT-7I01 EDT-7K01 EDT-7L05
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aroa Biosurgery
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|---|---|---|---|---|---|
| Device | CLASS II | OviTex 1S Reinforced BioScaffold 18x22cm recalled by AROA Biosurgery | AROA Biosurgery | Potency & Assay | 8 states |
| Device | CLASS II | OviTex Reinforced BioScaffold 10x12cm recalled by AROA Biosurgery | AROA Biosurgery | Potency & Assay | 8 states |
| Device | CLASS II | OviTex 1S Reinforced BioScaffold 16x20cm recalled by AROA Biosurgery | AROA Biosurgery | Potency & Assay | 8 states |
| Device | CLASS II | OviTex 1S Reinforced BioScaffold 10x20cm recalled by AROA Biosurgery | AROA Biosurgery | Potency & Assay | 8 states |
| Device | CLASS II | OviTex Reinforced BioScaffold 18x22cm recalled by AROA Biosurgery | AROA Biosurgery | Potency & Assay | 8 states |
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