Class II U.S. Food and Drug Administration

Mentor Texas, LP. Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H recall: Infusion sets may contain dull/blunt needle tip

Recall published 7 months ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1686-2026
Published
April 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Mentor Texas, LP.
Product type
Medical devices
Distribution
Nationwide
Made in
United States
Lot / code info
UDI(s): 10081317028168 10081317028175 10081317028199 10081317028243 10081317028250 10081317028267 10081317028274 10081317028151
UPC codes
10081317028168, 10081317028175, 10081317028199, 10081317028243, 10081317028250, 10081317028267, 10081317028274, 10081317028151

Products covered by this recall

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

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10081317028168
  • 10081317028175
  • 10081317028199
  • 10081317028243
  • 10081317028250
  • 10081317028267
  • 10081317028274
  • 10081317028151

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Mentor Texas, LP. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Mentor Texas, LP. — 3041 Skyway Cir N, Irving, TX, 75038-3524

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Mentor Texas, LP. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10081317028168, 10081317028175, 10081317028199. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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