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
- 00081317009450, 00081317009467, 00081317009542, 00081317009474, 00081317009481, 00081317009498, 00081317009504
- 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 textured implants used in breast reconstruction to create space for future implants. They are designed to gradually stretch tissue after mastectomy or lumpectomy and are selected by surgeons in consultation with patients.
Why This Is Dangerous
A dull needle tip in infusion sets can hinder the injection process and may break, creating a risk of incomplete administration or instrument failure.
Industry Context
This recall is not cited as part of a broader industry pattern in the provided notice.
Practical Guidance
How to identify if yours is affected
- Review the device label for Artoura Breast Tissue Expander and listed Reference Numbers.
- Compare against the recall list to determine if your device is affected.
Where to find product info
Refer to the FDA recall page for Z-1685-2026 and contact Mentor Texas, LP. for instructions.
What timeline to expect
Recall remedies typically involve replacement or guidance within weeks to a couple of months; follow manufacturer timelines in the recall letter.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Escalate to the FDA recall page or consumer safety authorities if there is no response within a reasonable period.
How to prevent similar issues
- Always verify recall status before accepting implanted devices or reusing infusion components.
- Ask healthcare providers to review UDIs and batch/lot information prior to procedures.
- Keep a record of all device identifiers for future reference.
Documentation advice
Save all recall notices, letters, and communications. Take photos of device labels and UDIs. Note dates of any clinical interactions related to the device.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: Artoura Breast Tissue Expanders. Reference numbers: TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH, TEXP150RH. Textured, high and ultra high profile with integral injection dome. Capacities listed as 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc. Manufacturer: Mentor Texas, LP. Distribution: Worldwide, including US nationwide and countries listed in the recall.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- High hazard level due to dull needle tip risk
- Model/Reference numbers: TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH, TEXP150R
- Global distribution including US and numerous countries
- Recall date: 2026-02-18; Status: Active
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.