Z-1685-2026Class II

Mentor Texas, LP.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Mentor Texas, LP.

Product type

Device

Status

Ongoing

Report date

2026-04-08

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.

Firm state

Initiated by

Voluntary: Firm initiated

Reason for recall

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

Product description

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,

Code / lot info

UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →