Reported Apr 8, 2026 · Ongoing
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H…
Mentor Texas, LP.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mentor Texas, LP. · 3041 Skyway Cir N · Irving, TX · 75038-3524
Is this the product you have?
- Artoura Breast
- Tissue Expanders Reference NumbersSmooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
SDC-100HSDC-110HSDC-120HSDC-130HSDC-135HSDC-140HSDC-150HSDC-155H
- Lot codes and dates
- UDI(s)
1008131702816810081317028175100813170281991008131702824310081317028250100813170282671008131702827410081317028151
- UDI(s)
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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