Class 2 Device Recall SURGIMESH XB

• Date Initiated by Firm: August 12, 2022
• Date Posted: June 17, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1984-2025
• Recall Event ID: 96930
• 510(K)Number: K072974
• Product Classification: Mesh, surgical, polymeric - Product Code FTL
• Product: SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
• Code Information: Lot Code: Reference Number: Tintra R-1415 UDI: (01)00850011929032(17)250701(10)Z2459695M Lot Number: Z2459695M Expiration Date: 2025-07-01
• Recalling Firm/ Manufacturer: Chamberlain Technologies LLC; 21805 W Field Pkwy; Deer Park IL 60010-3228
• For Additional Information Contact: Deeda Howard; 1-847-3044069
• Manufacturer Reason for Recall: Potential presence of residual adhesive material on the mesh surface.
• FDA Determined Cause: Process control
• Action: Customer notification began 8/12/22. Initial communication was made directly (by phone and in-person visit). This communication instructed users to segregate and return the affected product to BG Medical. If you have any questions, call 8473044069 or email: d.howard@surgimesh.com.
• Quantity in Commerce: 20 units
• Distribution: US distribution to states of: Illinois, Nebraska, & California
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FTL