FDA Enforcement
Class II
Ongoing
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
Recall: Z-1683-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1683-2026
- 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-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Code Info
10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403
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.