Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OviTex 1S Reinforced BioScaffold 6x10cm Recalled by AROA Biosurgery, LTD. Due to Degradation of the PGA suture material used in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AROA Biosurgery, LTD. directly.
Affected Products
OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
Quantity: 881 total
Why Was This Recalled?
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 specification respective to the number of tissue layers.
Where Was This Sold?
This product was distributed to 8 states: AL, CA, FL, IN, MA, MI, NH, NY
About AROA Biosurgery, LTD.
AROA Biosurgery, LTD. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report