[pending] Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135U
Pending LLM rewrite. Source: FDA_DEVICE Z-1687-2026.
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
- Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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