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FDA (Device enforcement)Recalled 2026-02-18class ii

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

Hazard

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

Details from the source

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. Lot/code info: UDI(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504

UPC codes

00081317009450, 00081317009467, 00081317009542, 00081317009474, 00081317009481, 00081317009498, 00081317009504

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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