Class II U.S. Food and Drug Administration

Mentor Texas, LP. CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers 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

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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-1684-2026
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):10081317028427 10081317028434 10081317028458 10081317028465
UPC codes
10081317028427, 10081317028434, 10081317028458, 10081317028465

Products covered by this recall

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

Check your product

The notice names 4 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.

  • 10081317028427
  • 10081317028434
  • 10081317028458
  • 10081317028465

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. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  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.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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 10081317028427, 10081317028434, 10081317028458. 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls