Facility

Aroa Biosurgery Ltd

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007321028
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	2 Kingsford Smith Place Airport Oaks Auckland, NZ 2022
Registration status	Active · expires 2026
Parent company	Aroa Biosurgery Ltd (owner-operator 10028943)
Brand names	Endoform Antimicrobial Restorative Bioscaffold

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Dressing, Wound, Drug
Product code FRO (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IITerminated2018-11-27
Potential for pouch seal failure
Class IITerminated2018-04-06
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst speci…

FDA inspections (1)

VAI2017-03-09
Voluntary Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Aroa Biosurgery Ltd

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Aroa Biosurgery Ltd (FEI 3007321028) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007321028-aroa-biosurgery-ltd/

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