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Recall Observatory FDA recall evidence

Device product

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)

Z-1681-2026

February 18, 2026

Class II

Product summary

Firm
Mentor Texas, LP.
Event
Event 98482
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1681-2026

Official wording

Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Code information: 00081317006671 00081317006794 00081317006800

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.