AROA Biosurgery, LTD.

Complete recall history across all FDA and CPSC categories — 21 total recalls

AROA Biosurgery, LTD. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (21)

FDA medical device enforcement actions by AROA Biosurgery, LTD.

Date Product Reason Class
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G Degradation of the PGA suture material used in the manufacture of the resorba... Class II
Apr 6, 2018 OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G Degradation of the PGA suture material used in the manufacture of the resorba... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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