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Medium risk Medical DevicesClass II

Artoura Breast Tissue Expanders Recall

Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & U

Updated February 18, 2026

Artoura Breast Tissue Expanders may come with infusion set needles that are dull or blunt, making them difficult to advance and risking breakage during use. This is a voluntary recall by the manufacturer.

Is the Mentor Texas, LP. recalled? Yes. This product was recalled by FDA on February 18, 2026. Details below.

What is recalled

Artoura Breast Tissue Expanders with reference numbers TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH, TEXP150RH in textured, high, and ultra-high profile designs, available in 300cc, 375cc, 475cc, 500cc, 535cc, 600cc, and 750cc sizes.

Am I affected

You're affected if you have an Artoura Breast Tissue Expander with a reference number (model) of TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH, or TEXP150RH, along with an infusion set needle.

What to do right now

Contact Mentor Texas, LP (the manufacturer) immediately if you have received or are using one of these expanders. Do not use the included infusion set needle if it appears dull or blunt, or if you experience difficulty advancing it.

The hazard

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

Brands affected

Mentor Texas, LP.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1685-2026
Classification
Class II
Recalled
February 18, 2026
Read the official notice

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