Surgical Mesh Product Recalled Due to Residual Adhesive Material
Chamberlain Technologies is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The product was distributed to facilities in 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard (residual adhesive material) is precautionary in nature and represents a low-risk manufacturing defect without documented adverse health consequences.
Plain-English summary
Chamberlain Technologies LLC is recalling SURGIMESH XB, a polymeric surgical mesh with a silicone barrier, due to the potential presence of residual adhesive material on the mesh surface. The affected product is the 14m x 15cm flat sheet model (Tintra R-1415), with 20 units distributed to medical facilities in Illinois, Nebraska, and California.
The recalled product carries lot number Z2459695M with an expiration date of July 1, 2025. The UDI is (01)00850011929032(17)250701(10)Z2459695M.
Healthcare providers and patients who have received or are aware of this product should contact Chamberlain Technologies LLC immediately for instructions on return or replacement.
The recalled product
- Product
- SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
- Manufacturer
- Chamberlain Technologies LLC
- Category
- Medical Device — Surgical Mesh
- Affected units
- 20
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 →- HighSurgical Mesh Recalled for Potential Residual Adhesive Material
FDA (Devices) · 2025-06-25
- ModerateSurgical Mesh Recalled for Potential 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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