Atlas FDA

SURGIMESH WN, Polymeric Surgical Mesh, Large Flat Sheet, Model/Catalog Number: T3030

FDA device recall Z-1983-2025 · posted 2025-06-17 · Open, Classified

Recall details

Recalling firm
Chamberlain Technologies LLC
Reason for recall
Potential presence of residual adhesive material on the mesh surface.
Action taken
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.
Root cause
Process control
Status
Open, Classified
Product code
FTL
Quantity affected
60 units
Distribution
US distribution to states of: Illinois, Nebraska, & California
Date initiated
2022-08-12
Date posted
2025-06-17
Location
Deer Park, IL

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Related 510(k) clearances

RecordFirmDate
SURGIMESH WN (K061445)Aspide Medical2007-02-01