Z-1682-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2026
- Initiation Date
- February 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Reason for Recall
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Distribution Pattern
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.
Code Information
10081317028335