FDA Medical Device Recalls (openFDA)
Chamberlain Technologies LLC: SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
- Recall number
- Z-1984-2025
- Recalling firm
- Chamberlain Technologies LLC
- Product
- SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
- Status
- Completed
- Initiated
- 2022-08-12
- Posted
- 2025-06-17
- Terminated
- not on file
- Reason
- Potential presence of residual adhesive material on the mesh surface.
- Root 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
- 20 units
- Distribution
- US distribution to states of: Illinois, Nebraska, & California
- Lot, serial or model codes
- Lot Code: Reference Number: Tintra R-1415 UDI: (01)00850011929032(17)250701(10)Z2459695M Lot Number: Z2459695M Expiration Date: 2025-07-01
- 510(k) numbers
- ["K072974"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 3015860534
- Firm city
- Deer Park
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28