# FDA recall Z-1686-2026

> **Mentor Texas, LP.** · Class II · device recall initiated 2026-02-18.

## 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 for recall

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

## Distribution

Worldwide distribution - US Nationwide and the countries of  Canada, Albania, Australia, 	Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, 	Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, 	Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.

## Key facts

- **Recall number:** Z-1686-2026
- **Recalling firm:** Mentor Texas, LP.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-18
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irving, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1686-2026

## Citation

> AI Analytics. FDA recall Z-1686-2026. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1686-2026. Source: US FDA. Licensed CC0.

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