Device recall
Z-1685-2026: Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH…
FDA device recall · Class II · Mentor Texas, LP.
Key facts
| Recall number (Z-number) | Z-1685-2026 |
|---|---|
| Recall event | 98482 |
| Product | Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc, |
| Product code | LCJ |
| Recalling firm | Mentor Texas, LP. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K150777 |
| 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