FDA Device recall Z-1685-2026
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &…
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &… by Mentor Texas, citing infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1685-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-18 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Mentor Texas |
| Distribution | US |
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,
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Identifiers
| code_info | UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1685-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.