FDA Medical devices recall ·
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model recall
- Recall number
- Z-1985-2025
- Date
- (initiated August 12, 2022)
- Company / brand
- Chamberlain Technologies LLC
21805 W Field Pkwy, Deer Park, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 10 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Why was it recalled?
Potential presence of residual adhesive material on the mesh surface.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Reference Number: Tintra E-3030 UDI: (01)00850011929063(17)250701(10)Z2459757G Lot Number: Z2459757G Expiration Date: 2025-07-01
Distribution
US distribution to states of: Illinois, Nebraska, & California
States: California Illinois Nebraska
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1985-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.