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Mentor Texas, LP.: Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &

Medical DevicesSource: FDA (device) · Date: 2026-04-08

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Mentor Texas, LP.
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 / hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-02-18
Code info
UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504
Voluntary mandated
Voluntary: Firm initiated
City
Irving
State
TX
Country
United States
Event id
98482
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