AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 16x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
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 involves a medical device that failed to meet pre-defined burst specifications, posing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
AROA Biosurgery, LTD. is recalling 881 units of OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G. 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 indicated 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.
Healthcare providers and patients should stop using the recalled devices and contact AROA Biosurgery for further instructions. The specific lot codes associated with this recall are ERT-6G08 and ERT-6J03.
The recalled product
- Product
- OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
- 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-6G08 ERT-6J03
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 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
- HighAROA Biosurgery Recalls OviTex 2S 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