CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113 recall (Mentor Texas, LP.)
Medical deviceClass IIOngoing
Summary: Mentor Texas, LP. is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc). Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
What is being recalled
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Why
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.
How to tell if yours is affected
00081317006671 00081317006794 00081317006800
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1681-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 18, 2026 |
| Reported | April 8, 2026 |
| Company | Mentor Texas, LP. |
| Company location | Irving, TX, United States |
| Initiated by | Voluntary: Firm initiated |
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