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)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | February 18, 2026 |
| Reported | April 08, 2026 |
| Recalling firm | Mentor Texas, LP. |
| Country / region | United States TX |
Hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Affected products
- 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,
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