The Recall Desk
HighFDA (Devices)·Z-1985-2025·Announced 2025-06-25

Surgical Mesh Recalled for Potential Residual Adhesive Material

Chamberlain Technologies LLC is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The affected product was distributed to Illinois, Nebraska, and California.

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: FDA Class II recall for a medical device where residual adhesive material poses a potential risk of harm if the product is used in surgery. The source does not report any illnesses or injuries, making this a theoretical risk-of-harm product that meets the High severity criterion.

Plain-English summary

Chamberlain Technologies LLC is recalling SURGIMESH XB, a polymeric surgical mesh (X-Large Ellipse Barrier Mesh, Model/Catalog Number Tintra E-3030), due to potential presence of residual adhesive material on the mesh surface. The recalled product consists of 10 units with Lot Number Z2459757G, UDI (01)00850011929063(17)250701(10)Z2459757G, and an expiration date of July 1, 2025.

The product was distributed to hospitals and surgical facilities in Illinois, Nebraska, and California. Patients or healthcare providers who have this product should contact Chamberlain Technologies LLC for instructions on product return or replacement.

The recalled product

Product
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Manufacturer
Chamberlain Technologies LLC
Category
Medical Device — Surgical Mesh
Hazard
  • residual-adhesive
  • device-defect

Distribution

Distribution scope not specified by the agency.

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