FDA Device recall Z-1687-2026
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Ti…
- 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-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Ti… 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-1687-2026 |
| 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-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Identifiers
| code_info | UDI(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281 |
|---|
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-1687-2026%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.