Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH… — Class II medical device recall Z-1687-2026
Ongoing recall by Mentor Texas, LP., reported 2026-04-08, distributed nationwide. Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
| Recall number | Z-1687-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mentor Texas, LP., Irving, TX, United States |
| Recall initiated | 2026-02-18 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BG, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HR, IE, IS, IT, NO, PK, PL, RO, SA, SE, SG, SI, SK, TW |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10081317028182, 10081317028205, 10081317028212, 10081317028229, 10081317028236, 10081317028281 |
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 for recall
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1687-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.