FDA Enforcement
Class II
Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Recall: Z-1682-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1682-2026
- Event ID
- 98482
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mentor Texas, LP.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2026
- Initiation Date
- February 18, 2026
- Classification Date
- March 27, 2026
- Address
- 3041 Skyway Cir N, Irving, TX, 75038-3524, United States
Description
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Code Info
10081317028335
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.