Z-1681-2026 Class II Ongoing
FDA device recall Z-1681-2026 was initiated by Mentor Texas, LP. on February 18, 2026 and is designated Class II. Reason for recall: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. The recall status is 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: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
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
00081317006671 00081317006794 00081317006800