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
- Model numbers
- SCPX-107MH, SCPX-117MH, SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH, 10081317028359, 10081317028366 +4 more
- Sizes
- 275cc, 350cc, 450cc, 550cc, 650cc +1 more
- 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 implanted devices used during reconstruction to create space for a future implant. They come in various sizes and are attached via sutures. This recall concerns CPX 4 US models with suture tabs.
Why This Is Dangerous
A dull needle tip in infusion sets can be hard to advance or may break, potentially complicating procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate stoppage of device use and follow-up with the physician for monitoring and guidance on replacement or alternative options.
Practical Guidance
How to identify if yours is affected
- Look for model numbers SCPX-107MH, SCPX-117MH, SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH on the device or documentation.
- Check internal codes 10081317028359 through 10081317028403 if listed in your records.
- Review the recall letter or FDA notice for details.
Where to find product info
FDA enforcement page for recall Z-1683-2026; manufacturer notification letters.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks after confirmation.
If the manufacturer is unresponsive
- Escalate to your surgeon or hospital risk management.
- File a complaint with the FDA if the manufacturer is uncooperative.
How to prevent similar issues
- Verify device model before use in future surgeries.
- Ask about suture-tab features and infusion-set compatibility.
- Keep all recall documentation and serial codes for reference.
Documentation advice
Keep recall letters, purchase records, device serial numbers, and all correspondence with the manufacturer.
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Product Details
Brand: Mentor Texas, LP. Models: SCPX-107MH, SCPX-117MH, SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH. Description: CPX 4 US Breast Tissue Expander with Suture Tabs. Sizes offered: 275cc, 350cc, 450cc, 550cc, 650cc, 800cc. Sold worldwide, including US nationwide and the listed countries. Price: Not disclosed. Note: Inner model numbers include 10081317028359, 10081317028366, 10081317028373, 10081317028380, 10081317028397, 10081317028403 (internal codes). Recall date: 2026-02-18. Status: Active.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- SCPX-156MH used worldwide from 275cc to 800cc
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Safety Guide
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