Device recall
Z-1686-2026: Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H…
FDA device recall · Class II · Mentor Texas, LP.
Key facts
| Recall number (Z-number) | Z-1686-2026 |
|---|---|
| Recall event | 98482 |
| Product | Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc |
| Product code | LCJ |
| Recalling firm | Mentor Texas, LP. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161176 |
| FEI number | 1000118360 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database