SurgiMesh Tintra E-3030Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K072974); 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.

Recalls naming this device

1. Aug 12, 2022Class IICompleted

   Potential presence of residual adhesive material on the mesh surface.

   Z-1985-2025 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072974. One submission often covers many models, so check the product and lot details in each record.

• Z-1984-2025 · Aug 12, 2022 · Completed
  SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415