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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 10
Distribution
Part of a larger recall action
This product is one of 4 recalled by Chamberlain Technologies LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Chamberlain Technologies LLC
See all →- ModerateSurgical Mesh Recalled for Potential Residual Adhesive Material
FDA (Devices) · 2025-06-25
- ModerateSurgical Mesh Product Recalled Due to Residual Adhesive Material
FDA (Devices) · 2025-06-25
- ModerateSurgical Mesh Recalled Due to Residual Adhesive Material Concern
FDA (Devices) · 2025-06-25
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