FDAFebruary 18, 2026device
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)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
What to do
FDA enforcement status: Ongoing
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAArtoura 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, 850cc2026-02-18
- FDACPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 550cc, 650cc, 800cc2026-02-18
- FDACPX 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, 750cc2026-02-18
- FDAArtoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,2026-02-18
- FDACPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc2026-02-18
- FDAArtoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc2026-02-18
- CPSCNazzaro Recalls Children Bowling Pin Sipper Cups Due to Risk of Lead Poisoning; Violation of Federal Lead Content Ban2025-02-20
- FDA1lb and 8oz bags include Apricots, Whole Dates, golden Raisins, Mangos, Currants, Blueberries, Cranberries, Prunes, Raw Sunflower Seeds, Raw Pumpkin Seeds, Pecan Medium Pieces, Blanched Sliced Almonds, Natural Sliced Almonds, Blanched Slivered Almonds, Blanched Whole Almonds and Raw Blanched Peanuts2024-05-08
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