FDA Device recall Z-1984-2025
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
- FDA Device
- Class II
- completed
- Published 2025-06-25
On 2025-06-25 the FDA classified a Class II recall of SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415 by Chamberlain Technologies, citing potential presence of residual adhesive material on the mesh surface.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1984-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-08-12 |
| Published | 2025-06-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Chamberlain Technologies |
| Distribution | CA, IL, NE |
Product
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Reason
Potential presence of residual adhesive material on the mesh surface.
Identifiers
| code_info | Lot Code: Reference Number: Tintra R-1415 UDI: (01)00850011929032(17)250701(10)Z2459695M Lot Number: Z2459695M Expiration Date: 2025-07-01 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1984-2025%22
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