AROA BIOSURGERY: Medical Device Recall in 2018 - (Recall #: Z-0378-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 27, 2018

Date Posted: November 14, 2018

Recall Number: Z-0378-2019

Event ID: 81161

Reason for Recall:

Potential for pouch seal failure

Status: Terminated

Product Quantity: 8,853 total boxes

Code Information:

Lot numbers: EDT-7I01 EDT-7K01 EDT-7L05

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated