Skip to main content

FDA recall, , Moderate risk

Mentor Breast Tissue Expanders

Artoura Breast Tissue Expanders may have infusion sets with dull or blunt needle tips that may be difficult to advance and/or break.

Summary by Recall Canary from the FDA notice

What happened

Mentor Texas, LP, of Irving, Texas, recalled Artoura Breast Tissue Expanders and CPX 4 US Breast Tissue Expanders with Suture Tabs because infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. The recall began February 18, 2026, and was added to the FDA's Enforcement Report on March 27, 2026, with distribution nationwide and worldwide in multiple countries.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Product details

    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,

    UDI-DI
    • 00081317009450
    • 00081317009467
    • 00081317009542
    • 00081317009474
    • 00081317009481
    • 00081317009498
    • 00081317009504

  2. 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

    UDI-DI
    • 10081317028427
    • 10081317028434
    • 10081317028458
    • 10081317028465

  3. 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

    UDI-DI
    • 10081317028168
    • 10081317028175
    • 10081317028199
    • 10081317028243
    • 10081317028250
    • 10081317028267
    • 10081317028274
    • 10081317028151

  4. 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

    UDI-DI
    • 10081317028359
    • 10081317028366
    • 10081317028373
    • 10081317028380
    • 10081317028397
    • 10081317028403

  5. 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

    UDI-DI
    • 10081317028182
    • 10081317028205
    • 10081317028212
    • 10081317028229
    • 10081317028236
    • 10081317028281

  6. CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

    UDI-DI
    • 10081317028335

  7. 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)

    UDI-DI
    • 00081317006671
    • 00081317006794
    • 00081317006800

Recall details

Company began the recall
Sold in

Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic.

Company
Mentor Texas, LP.Irving, Texas
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98482
Recall numbers
Z-1681-2026 to Z-1687-2026

All recalls from Mentor Texas, LP.

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Other device defect recalls

See all: Other device defect recalls

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)