FDA Device recall Z-1686-2026
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Prof…
- 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: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Prof… 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-1686-2026 |
| 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: 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
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Identifiers
| code_info | UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151 |
|---|
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-1686-2026%22
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