Quick Facts at a Glance
- Recall Date
- February 18, 2026
- Hazard Level
- HIGH
- Brand
- Mentor Texas
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Mentor Texas
- Product type
- Breast Tissue Expander with Suture Tabs
- Model numbers
- SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH, 10081317028427, 10081317028434, 10081317028458, 10081317028465
- Sizes
- 350cc, 450cc, 650cc, 750cc
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 18, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mentor Texas, LP. or your healthcare provider for instructions. Notification method: Letter
About This Product
Breast tissue expanders are temporary devices used in reconstructive surgery to create space for implants. The CPX 4 line offers suture tabs and comes in several sizes, including 350cc, 450cc, 650cc, and 750cc.
Why This Is Dangerous
A dull or blunt needle tip in infusion sets can be difficult to advance and may break, potentially complicating procedures or causing tissue injury.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
Patients may require additional medical procedures and potential delays in reconstruction. The recall emphasizes immediate cessation of use and following manufacturer instructions to mitigate risk.
Practical Guidance
How to identify if yours is affected
- Check for reference numbers SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH.
- Consult your surgeon if you are unsure whether your device is affected.
Where to find product info
On device packaging, labeling, and the recall notice from Mentor Texas LP. The FDA recall page provides the enforceable details.
What timeline to expect
Not specified in recall notice.
If the manufacturer is unresponsive
- File a complaint with the FDA recall program if the provider or manufacturer is unresponsive.
- Document all communications and keep copies of the recall notice and device identifiers.
How to prevent similar issues
- Ask about device sterility and needle design before implant procedures.
- Ensure appropriate training on tissue expander handling.
- Verify device recalls during preoperative planning and instrument inventory checks.
Documentation advice
Keep the recall letter, device labeling, serial numbers, UDIs, and all communications. Photograph any packaging and store for records.
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Product Details
Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Product: CPX 4 US Breast Tissue Expanders with Suture Tabs Sizes: 350cc, 450cc, 650cc, 750cc Brand: Mentor Texas, LP Sold worldwide: US nationwide and numerous countries Recall Date: 2026-02-18 Status: Active UDI: 10081317028427, 10081317028434, 10081317028458, 10081317028465
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution including US nationwide
- Four reference numbers SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH
- Sizes 350cc, 450cc, 650cc, 750cc
- Hazard: dull needle tip may be difficult to advance or break
- Status: Active recall
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Safety Guide
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