FDA Medical devices recall ·
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers:… recall
- Recall number
- Z-1683-2026
- Date
- (initiated February 18, 2026)
- Company / brand
- Mentor Texas, LP.
3041 Skyway Cir N, Irving, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
10081317028359 10081317028366 10081317028373 10081317028380 10081317028397 10081317028403
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1683-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.