FDA recall Z-1683-2026

Mentor Texas, LP. · Class II · device

Product

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc

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.

Key facts

Status
Ongoing
Initiation date
2026-02-18
Report date
2026-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1683-2026