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 US Breast Tissue Expanders because some infusion sets may have dull or blunt needle tips. These dull needles can be hard to insert and may break during use. No injuries have been reported.
- If you received this device, contact your surgeon or Mentor immediately
- Do not use the infusion set if the needle appears dull or damaged
- Ask your healthcare provider about replacement or alternatives
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-157LH Smooth Low Height Tissue Expander, 650cc
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1682-2026Want us to check the next one for you?
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