Quick Facts at a Glance
- Recall Date
- February 18, 2026
- Hazard Level
- HIGH
- Brand
- Mentor Texas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Model numbers
- 10081317028335, SCPX-157LH
- Sizes
- 650cc
- Sold at
- Multiple Retailers
- 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 implanted devices used in breast reconstruction to create space for subsequent implants. They are gradually filled to stretch tissue.
Why This Is Dangerous
A dull or blunt infusion needle tip may hinder infusion and could break, potentially compromising the reconstruction procedure.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall affects patients undergoing breast reconstruction. Stopping use requires medical guidance and potential device replacement, which may affect treatment timelines and costs.
Practical Guidance
How to identify if yours is affected
- Check if your device has SCPX-157LH and is labeled 650cc Smooth Low Height Tissue Expander.
- Verify the Reference Number SCPX-157LH on the device or packaging.
- Confirm the product is within the recall distribution.
Where to find product info
Manufacturer recall notice and FDA enforcement page list identification codes and steps. The FDA page linked in the recall provides official details.
What timeline to expect
4-8 weeks for refunds or replacements, depending on supplier and surgeon coordination.
If the manufacturer is unresponsive
- Document all contact attempts with Mentor Texas, LP.
- File a recall complaint with the FDA if the manufacturer is unresponsive.
- Consult your surgeon for interim guidance on reconstruction planning.
How to prevent similar issues
- Always verify recall status before proceeding with breast reconstruction devices.
- Ask surgeons or vendors for current recall status and replacement options.
- Avoid using second-hand devices or previously implanted devices without clearance.
Documentation advice
Keep recall notice, correspondence with manufacturer, surgeon notes, and photos of device labels.
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Product Details
Product: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference numbers: SCPX-157LH Model: Smooth Low Height Tissue Expander, 650cc Sold worldwide, including US nationwide Countries involved: 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 Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- SCPX-157LH reference number
- Worldwide distribution including US
- High hazard recall
- Infusion set needle-tip risk
- Active recall as of 2026-02-18
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Safety Guide
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