Medical device recalls Moderate risk

Chamberlain Technologies LLC recalls SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415

Recall date
August 12, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1984-2025
FDA classification
Class II
Brand / firm
Chamberlain Technologies LLC
Sold / distributed
US distribution to states of: Illinois, Nebraska, & California

Why it was recalled

Potential presence of residual adhesive material on the mesh surface.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415

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