Lower risk Medical device recall · FDA · Published February 18, 2026

Mentor Artoura Breast Tissue Expanders Recall: Dull Needle Tip Risk

Mentor recalls Artoura Breast Tissue Expanders with dull needle tips that may break or be hard to advance. Affected models include TEXP110RH to TEXP140RH. Contact for replacement.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1685-2026Medical device Mentor ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmMentor Texas, LP.3041 Skyway Cir N · Irving, TX 75038-3524

✎ GovInfoNow plain-language explainer

Mentor is recalling Artoura Breast Tissue Expanders that may have dull or blunt needle tips. This could make the needles difficult to advance or break, potentially causing complications during use. Read more at govinfonow.com/recall/49956-mentor-artoura-breast-tissue-expanders-recall-dull-needle-tip-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49956-mentor-artoura-breast-tissue-expanders-recall-dull-needle-tip-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1685-2026

Cite this page

“Mentor Artoura Breast Tissue Expanders Recall: Dull Needle Tip Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49956-mentor-artoura-breast-tissue-expanders-recall-dull-needle-tip-risk. Based on FDA recall #Z-1685-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1685-2026%22&limit=1).

The FDA announced on Feb. 18, 2026, that Mentor Texas LP is recalling Artoura Breast Tissue Expanders due to infusion sets with dull or blunt needle tips that may be difficult to advance and could break. The agency issued recall number Z-1685-2026 for the Class II voluntary recall.

How to tell if you have it

Brand: Mentor
Product: Artoura Breast Tissue Expanders
Reference Numbers: TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH
Profiles: Textured, High & Ultra High Profile
Dome: Integral Injection Dome
Sizes: 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc
UDIs: 00081317009450, 00081317009467, 00081317009542, 00081317009474, 00081317009481, 00081317009498, 00081317009504
Distribution: Worldwide, including US, Canada, and multiple European and Asian countries

The hazard

According to the FDA, the infusion sets associated with these expanders may contain dull or blunt needle tips. This defect can make the needles difficult to advance and may cause them to break during use.

Context

GovInfoNow's records show Mentor Texas LP has two other recalls on file since Sept. 30, 2021. On April 28, 2026, the company recalled Mentor Syringe Luer Lok 10cc-200 Box units due to expired syringes distributed via a control failure. On Sept. 30, 2021, Mentor issued a recall for saline-filled breast implants citing potential leakage from manufacturing issues. Other recent recalls of similar products include B. Braun 21G Winged Infusion Needle Recall (Feb. 2, 2026), B. Braun 21GA Winged Infusion Needle Recall (Feb. 2, 2026), and B. Braun 21GA Winged Inf Set Recall (Feb. 2, 2026).

How to tell if you have this one

Check the reference numbers on the expanders: TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH, or TEXP150RH. These models have textured, high and ultra high profile designs with specific capacities.

Brand
Mentor
Category
Medical device

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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.

Recall number	Product, codes & lots	Quantity
Z-1681-2026	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); 00081317006671 00081317006794 00081317006800	—
Z-1682-2026	CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc; 10081317028335	—
Z-1683-2026	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; 10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403	—
Z-1684-2026	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(s):10081317028427 10081317028434 10081317028458 10081317028465	—
Z-1685-2026	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(s): 00081317009450 00081317009467 00081317009542 00081317009474 00081317009481 00081317009498 00081317009504	—
Z-1686-2026	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(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151	—
Z-1687-2026	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(s): 10081317028182 10081317028205 10081317028212 10081317028229 10081317028236 10081317028281	—

Based on the official FDA remedy

What to do — step by step

Check Reference Numbers
Look for the reference numbers TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH, or TEXP150RH on the expanders.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 49 days after the firm started it.

Feb 18, 2026Firm started the recall
Mar 27, 2026FDA classified it Class II
Apr 8, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49956-mentor-artoura-breast-tissue-expanders-recall-dull-needle-tip-risk">Mentor Artoura Breast Tissue Expanders Recall: Dull Needle Tip Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1685-2026 (February 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1685-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.