CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Sm
Summary
The FDA issued a Class II for CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH by Mentor Texas, LP.. Reason: Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break..
Details
Source
Device Recall
External ID
Z-1684-2026
Action Date
2026-04-08
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI(s):10081317028427 10081317028434 10081317028458 10081317028465
Reason for Recall
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-18
Company
Irving, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mentor Texas, LP. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mentor Texas, LP.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mentor Texas, LP. have FDA actions?
Mentor Texas, LP. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1684-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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