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, 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 Texas
- Product type
- Breast Tissue Expander
- Model numbers
- SDC-100UH, SDC-110UH, SDC-120UH, SDC-130UH, SDC-135UH, SDC-140UH
- Sizes
- 350cc, 455cc, 535cc, 650cc, 700cc +1 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 medical devices used in breast reconstruction to prepare for future implant placement.
Why This Is Dangerous
A dull needle tip in the infusion set can hinder administration and may risk a break, potentially affecting treatment.
Industry Context
Unknown; this recall notice does not state whether it is part of a broader industry pattern.
Real-World Impact
The recall could affect patients undergoing reconstruction who rely on timely infusion therapy. Immediate cessation and provider guidance are required.
Practical Guidance
How to identify if yours is affected
- Check Reference Numbers: SDC-100UH, SDC-110UH, SDC-120UH, SDC-130UH, SDC-135UH, SDC-140UH
- Verify device type as Artoura Breast Tissue Expander with infusion set
Where to find product info
UDI labels on device packaging and labeling materials; recall notice provides reference numbers
What timeline to expect
No specific timeline for refunds or replacements is provided in the recall notice
If the manufacturer is unresponsive
- Document all communications with the brand and healthcare providers
- Escalate to regulatory authorities if the company is unresponsive
- Consider seeking legal advice for injuries or prolonged noncompliance
How to prevent similar issues
- Verify device recalls before procedures
- Monitor physician communications for recall updates
- Keep documentation of device lot/reference numbers when undergoing treatment
Documentation advice
Keep the recall notice, device labeling, purchase records, and all communications with providers and the manufacturer
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Product Details
Product: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH, SDC-110UH, SDC-120UH, SDC-130UH, SDC-135UH, SDC-140UH UDIs: 10081317028182, 10081317028205, 10081317028212, 10081317028229, 10081317028236, 10081317028281 Sizes: 350cc, 455cc, 535cc, 650cc, 700cc, 850cc Brand/Manufacturer: Mentor Texas, LP Distribution: Worldwide, including US nationwide and numerous countries Sold by: Mentor Texas, LP Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Artoura recall includes six reference numbers (SDC-100UH through SDC-140UH)
- Global distribution including US and many countries
- Hazard rated HIGH by the FDA recall
- UDI codes listed for each model
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Safety Guide
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