RegWardenFDA facility compliance records
Company

Aroa Biosurgery Ltd

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

Recalls by year

FDA actions on record by year2018: 2 recalls20172201820192020202120222023202420252026
  • Recalls (2)

Registered facilities (1)

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…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Aroa Biosurgery Ltd — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10028943-aroa-biosurgery-ltd/

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