SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse… recallZ-1985-2025 · Chamberlain Technologies LLC · initiated Aug 12, 2022
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Chamberlain Technologies LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential presence of residual adhesive material on the mesh surface.
FDA root cause category: Process control
What the company is doing
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: [email protected].
Recall details
- Recall number
- Z-1985-2025
- Status
- Completed
- Initiated by the company
- Aug 12, 2022
- Posted by the FDA
- Jun 17, 2025
- Recalling firm
- Chamberlain Technologies LLC
- Quantity
- 10 units
- Product code
- FTL
- FDA submissions
- K072974
- Distribution
- US distribution to states of: Illinois, Nebraska, & California
Product description
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Code information (models, lots, serial numbers)
Lot Code: Reference Number: Tintra E-3030 UDI: (01)00850011929063(17)250701(10)Z2459757G Lot Number: Z2459757G Expiration Date: 2025-07-01
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SurgiMesh Tintra E-3030Bg Medical, LLC · Mesh, Surgical, Polymeric1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K072974 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SurgiMesh Tintra R-1415Bg Medical, LLC · Mesh, Surgical, Polymeric1 recall1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 96930).
- Z-1983-2025 · CompletedSURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030
- Z-1984-2025 · CompletedSURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
- Z-1986-2025 · CompletedSURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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