AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (degradation of suture material) in a medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AROA Biosurgery, LTD. is recalling 881 units of OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G. The recall was initiated after an ongoing product stability study observed degradation in the PGA suture material used to manufacture these resorbable mesh devices.
Further investigation determined that devices older than 18 months showed evidence of no longer meeting the pre-defined ball burst specification relative to the number of tissue layers. The affected products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. The specific lot codes associated with this recall are ERT-6E05, ERT-6E06, and ERT-7K02.
Healthcare providers and consumers should stop using these devices and contact AROA Biosurgery, LTD. for instructions on how to return the product. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
- Manufacturer
- AROA Biosurgery, LTD.
- Category
- Medical Device — Surgical Mesh
- Affected units
- 881
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ERT-6E05 ERT-6E06 ERT-7K02
Distribution
Part of a larger recall action
This product is one of 21 recalled by AROA Biosurgery, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
Same manufacturer · AROA Biosurgery, LTD.
See all →- HighAROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
- HighAROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
- HighAROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Devices
FDA (Devices) · 2018-11-21
- SevereAROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
- HighAROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
Same hazard · material degradation
See all →- HighInspire respiratory sensing leads labeled with Use By dates beyond shelf life
FDA (Devices) · 2026-06-24
- HighInspire stimulation leads labeled with Use By dates beyond shelf life
FDA (Devices) · 2026-06-24
- HighHead ski boot shell and sole inserts can deteriorate and break
CPSC · 2026-04-09
- Severe
- HighMedical examination gloves recalled for skin irritation and disintegration
FDA (Devices) · 2024-07-17