Quick Facts at a Glance
- Recall Date
- February 18, 2026
- Hazard Level
- HIGH
- Brand
- Mentor
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- Product type
- Infusion Set for Breast Tissue Expander
- Model numbers
- SDC-100H, SDC-110H, SDC-120H, SDC-130H, SDC-135H, SDC-140H, SDC-150H, SDC-155H
- Sizes
- 225cc, 300cc, 375cc, 475cc, 500cc +3 more
- 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 15, 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
Artoura Breast Tissue Expanders are used in breast reconstruction to gradually create space for implants. They are paired with infusion sets during the procedure.
Why This Is Dangerous
A dull needle tip in infusion sets can hinder advancement or break, potentially impacting the delivery of therapeutic agents during reconstruction.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects patients undergoing breast reconstruction and may require urgent medical guidance and potential treatment changes.
Practical Guidance
How to identify if yours is affected
- Check model numbers against SDC-100H to SDC-155H list
- Confirm distribution country on recall notice
- Contact healthcare provider or Mentor for instructions
Where to find product info
Recall letter from manufacturer, FDA recall page, device packaging and labeling
What timeline to expect
Refund or replacement processing typically follows 4-8 weeks after confirmation of eligibility.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- File a complaint with the FDA if no response to the recall
- Consult your surgeon for interim safety guidance
How to prevent similar issues
- Verify recall status before any future breast reconstruction devices
- Check recall databases for updates
- Request official recall notices and replacement options before using any device
Documentation advice
Keep copies of the recall letter, model and UDI numbers, purchase records, and all correspondence with the manufacturer and healthcare providers
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Product Details
Model numbers include SDC-100H, SDC-110H, SDC-120H, SDC-130H, SDC-135H, SDC-140H, SDC-150H, SDC-155H. Infusion sets come in sizes 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc. UDI numbers include 10081317028168, 10081317028175, 10081317028199, 10081317028243, 10081317028250, 10081317028267, 10081317028274, 10081317028151. Distribution is worldwide, including 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,
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers: SDC-100H, SDC-110H, SDC-120H, SDC-130H, SDC-135H, SDC-140H, SDC-150H, SDC-155H
- Hazard: dull/blunt needle tip may be difficult to advance or break
- Distribution: Worldwide including US, Canada, and many other countries
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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