CLASS II Device recall · Reported 25 Jun 2025 · FDA Enforcement Report
Surgimesh XB, Polymeric Surgical Mesh, 14m Flat Sheet recalled
Chamberlain Technologies is recalling Surgimesh XB, Polymeric Surgical Mesh, 14m Flat Sheet with Silicone Barrier, distributed in California, Illinois, Nebraska. The recall was initiated on 12 Aug 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1984-2025
- FDA event ID
- 96930
- Recalling firm
- Chamberlain Technologies, Deer Park, IL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 12 Aug 2022
- FDA classified
- 17 Jun 2025
- Reported
- 25 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 12 Aug 2022 | Recall initiated by company | |
| 17 Jun 2025 | Classified by FDA | +1040 days |
| 25 Jun 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential presence of residual adhesive material on the mesh surface.
Product as listed by the FDA
SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415
Where it was distributed
US distribution to states of: Illinois, Nebraska, & California
Questions about this recall
Why was it recalled?
Potential presence of residual adhesive material on the mesh surface.
Which lots are affected?
Lot Code: Reference Number: Tintra R-1415 UDI: (01)00850011929032(17)250701(10)Z2459695M Lot Number: Z2459695M Expiration Date: 2025-07-01
Where was it sold?
US distribution to states of: Illinois, Nebraska, & California
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 96930This product is part of a recall event; the main page for the event is Surgimesh WN, Polymeric Surgical Mesh Flat Sheet recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Surgimesh WN, Polymeric Surgical Mesh Flat Sheet recalled | Chamberlain Technologies | Other | CA, IL, NE | |
| CLASS II | Surgimesh XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh recalled | Chamberlain Technologies | Other | CA, IL, NE | |
| CLASS II | Surgimesh WN, Polymeric Surgical Mesh, Large Flat Sheet recalled | Chamberlain Technologies | Other | CA, IL, NE |
More recalls from Chamberlain Technologies
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Surgimesh WN, Polymeric Surgical Mesh, Large Flat Sheet recalled | Chamberlain Technologies | Other | CA, IL, NE |
| Device | CLASS II | Surgimesh XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh recalled | Chamberlain Technologies | Other | CA, IL, NE |
| Device | CLASS II | Surgimesh WN, Polymeric Surgical Mesh Flat Sheet recalled | Chamberlain Technologies | Other | CA, IL, NE |
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| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |