[pending] CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-1
Pending LLM rewrite. Source: FDA_DEVICE Z-1684-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
The recalled product
- Product
- CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI(s):10081317028427 10081317028434 10081317028458 10081317028465
Distribution
Distributed nationwide across the United States.
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