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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: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

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: 10081317028335

UPC codes

10081317028335

Source

Official record: FDA (Device enforcement)

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

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