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OviTex® 1S F10256-1020GRecalls & reported problems

Aroa Biosurgery Limited · The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction. · Class 2 · Implant

All models of OviTex 1S (12)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09421904065314), received between Jul 11, 2022 and Jul 11, 2022 — classified as 1 injury.

21 other recalls cover devices cleared under the same FDA submission (K153633); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Bowel Perforation1
  • Obstruction/Occlusion1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT APPROXIMATELY 5 DAYS AFTER HERNIA REPAIR WITH OVITEX 1S RESORBABLE THAT A PATIENT EXPERIENCED SYMPTOMS OF A SMALL BOWEL OBSTRUCTION. MEDICAL TREATMENT ALONE WAS UNSUCCESSFUL AND THE PATIENT RETURNED TO SURGERY WHERE THE SMALL BOWEL WAS RESECTED. DURING SURGERY IT WAS NOTED THAT THE BOWEL WAS MARKEDLY ADHERENT TO THE ABDOMINAL WALL. A MINUTE SMALL BOWEL PERFORATION WAS ALSO NOTED.

    Patient problems: Bowel Perforation; Obstruction/Occlusion

    MAUDE report 14982733 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153633. One submission often covers many models, so check the product and lot details in each record.

  • Z-0416-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
  • Z-0426-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
  • Z-0428-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
  • Z-0421-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
  • Z-0422-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
  • Z-0424-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
  • Z-0418-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
  • Z-0425-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
  • Z-0423-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
  • Z-0427-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
  • Z-0434-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
  • Z-0431-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
  • Z-0420-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
  • Z-0415-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
  • Z-0430-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G

…and 6 more.

Other Mesh, Surgical devices

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Sources and updates

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