# FDA recall Z-1685-2026

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

## 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 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-1685-2026
- **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-1685-2026

## Citation

> AI Analytics. FDA recall Z-1685-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1685-2026. Source: US FDA. Licensed CC0.

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