Exact FDA event identifier

Event 81161

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: November 27, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: AROA BIOSURGERY

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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.

Z-0377-2019

Recall number: Z-0377-2019
Initiated: November 27, 2018
Classification: Class II
Status: Terminated
Recalling firm: AROA BIOSURGERY
Quantity: 8,853 total boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

pouch seal failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for pouch seal failure

Code information

Lot numbers: EDT-7H06 EDT-7L01 EDT-7L03 EDT-8A01

Distribution pattern

US Nationwide Distribution

device · product 2 of 3

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.

Z-0378-2019

Recall number: Z-0378-2019
Initiated: November 27, 2018
Classification: Class II
Status: Terminated
Recalling firm: AROA BIOSURGERY
Quantity: 8,853 total boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

pouch seal failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for pouch seal failure

Code information

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

Distribution pattern

US Nationwide Distribution

device · product 3 of 3

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.

Z-0379-2019

Recall number: Z-0379-2019
Initiated: November 27, 2018
Classification: Class II
Status: Terminated
Recalling firm: AROA BIOSURGERY
Quantity: 8,853 total boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

pouch seal failure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for pouch seal failure

Code information

Lot numbers: EDT-7I02 EDT-7L02

Distribution pattern

US Nationwide Distribution