The Recall Desk

FDA (Devices) recall action 98482

Mentor Texas, LP. recalled 7 products on 2026-04-08

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2026-04-08
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

1–7 of 7

  • HighFDA (Devices)··2026-04-08

    Artoura textured tissue expander infusion set needles may be blunt

    Mentor is recalling textured Artoura Breast Tissue Expanders with integral injection dome because the infusion sets may contain a dull or blunt needle tip.

    Product
    Artoura 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,
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-04-08

    CPX 4 medium height tissue expander infusion needles may be blunt

    Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth medium height range because the infusion sets may contain a dull or blunt needle tip.

    Product
    CPX 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, 800cc
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-04-08

    CPX 4 tall height tissue expander infusion needles may be blunt

    Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the smooth tall height range because the infusion sets may contain a dull or blunt needle tip.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-04-08

    CPX 4 SILTEX low height expander infusion needles may be blunt

    Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the SILTEX low height range because the infusion sets may contain a dull or blunt needle tip.

    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)
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-04-08

    CPX 4 low height tissue expander infusion needles may be blunt

    Mentor is recalling the CPX 4 US Breast Tissue Expander with Suture Tabs, smooth low height 650 cc, because the infusion sets may contain a dull or blunt needle tip.

    Product
    CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-04-08

    Artoura breast tissue expander infusion set needles may be blunt

    Mentor Texas is recalling Artoura Breast Tissue Expanders because the infusion sets may contain a dull or blunt needle tip that may be difficult to advance or may break.

    Product
    Artoura 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, 850cc
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-04-08

    Artoura ultra high profile expander infusion needles may be blunt

    Mentor is recalling Artoura Breast Tissue Expanders in the smooth ultra high profile range because the infusion sets may contain a dull or blunt needle tip.

    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
    Category
    Distribution
    0 states