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

Mentor Texas, LP.: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)

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: 00081317006671 00081317006794 00081317006800

UPC codes

00081317006671, 00081317006794, 00081317006800

Source

Official record: FDA (Device enforcement)

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

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