FDA-Device2026-04-08Class IIPROCESSING DEFECT
Mentor CPX 4 breast tissue expanders recalled for defective infusion set needles
What this means
Mentor Texas has recalled CPX 4 breast tissue expanders because the infusion sets may have dull or blunt needle tips. This can make the needle difficult to insert during treatment or cause it to break. No injuries have been reported.
- If you have received a CPX 4 tissue expander, contact your surgeon or healthcare provider immediately
- Do not use the device until you speak with your medical team
- Ask your provider about replacement options or alternative products
The agency's original wording
Hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Manufactured in
3041 Skyway Cir N, Irving, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1683-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.