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Artoura Breast Tissue Expanders
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MEDICAL DEVICE RECALLMODERATE

Artoura Breast Tissue Expanders

A recall was issued for Artoura Breast Tissue Expanders due to infusion sets that may contain dull or blunt needle tips.

What to do

See the official recall notice for details about this consumer action.

Recalled
Listed
Updated
Recall No.
Z-1685-2026
Agency
FDA
Firm
Mentor Texas, LP.
Recall ID
98482
Status
ONGOING

Why it was recalled

A recall was issued for Artoura Breast Tissue Expanders due to infusion sets that may contain dull or blunt needle tips. A dull or blunt needle may be difficult to advance during the filling procedure, which could lead to complications or device malfunction.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DI
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,Z-1685-202600081317009450, 00081317009467, 00081317009542, 00081317009474, 00081317009481, 00081317009498, 00081317009504
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, 750ccZ-1684-202610081317028427, 10081317028434, 10081317028458, 10081317028465
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, 850ccZ-1686-202610081317028168, 10081317028175, 10081317028199, 10081317028243, 10081317028250, 10081317028267, 10081317028274, 10081317028151
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, 800ccZ-1683-202610081317028359, 10081317028366, 10081317028373, 10081317028380, 10081317028397, 10081317028403
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, 850ccZ-1687-202610081317028182, 10081317028205, 10081317028212, 10081317028229, 10081317028236, 10081317028281
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650ccZ-1682-202610081317028335
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-1681-202600081317006671, 00081317006794, 00081317006800

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

← Back to all recalls

Editorial summary by Recall Canary · summary updated 2026-09-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification