FDA Enforcement
Class II
Ongoing
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Recall: Z-1681-2026
·
Reported April 8, 2026
Enforcement
- Recall Number
- Z-1681-2026
- 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: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Reason
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Code Info
00081317006671 00081317006794 00081317006800
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.