Z-1985-2025Class II

SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030

Name: Z-1985-2025 SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Creator: Chamberlain Technologies LLC
Published: 2022-08-12
License: https://open.fda.gov/license/

Chamberlain Technologies LLC / initiated 2022-08-12 / Open, Classified / root cause: manufacturing process

FDA source

Chamberlain Technologies LLC began a recall of SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030 on 2022-08-12. FDA classified it as Class II and gives the reason as "Potential presence of residual adhesive material on the mesh surface". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1985-2025
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-12
Posted: 2025-06-17
Recalling firm: Chamberlain Technologies LLC
Product: SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Potential presence of residual adhesive material on the mesh surface.
Root cause tag: manufacturing process
FDA 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: [email protected].
Quantity in commerce: 10 units
Distribution: US distribution to states of: Illinois, Nebraska, & California
Product codes and lots: Lot Code: Reference Number: Tintra E-3030 UDI: (01)00850011929063(17)250701(10)Z2459757G Lot Number: Z2459757G Expiration Date: 2025-07-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1985-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1983-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-17
Z-1984-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-17
Z-1985-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-17
Z-1986-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-17

Product code FTL

K072974Class IISurgimesh XbAspide Medical / cleared 2008-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)