Quick Facts at a Glance
- Recall Date
- February 18, 2026
- Hazard Level
- HIGH
- Brand
- Mentor Texas LP
- 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 LP
- Product type
- Breast Tissue Expander
- Model numbers
- 00081317006671, 00081317006794, 00081317006800
- 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 reconstructive breast surgery to gradually create space for a final implant. They are attached to a tissue expander system and filled over weeks. This recall concerns the infusion sets used with CPX 4 tissue expanders.
Why This Is Dangerous
A dull needle tip in infusion sets can be difficult to advance or may break during a procedure. This can complicate procedures and pose injury risks to patients and healthcare staff.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided information.
Real-World Impact
For patients, the recall requires immediate cessation of use with affected devices. Medical facilities must review inventory and coordinate with surgeons on next steps, which could affect treatment timelines and scheduling.
Practical Guidance
How to identify if yours is affected
- Verify device is a CPX 4 US Breast Tissue Expander with Suture Tabs
What timeline to expect
Remedy and replacement/reimbursement will be communicated by letter; expect several weeks to process after submission
If the manufacturer is unresponsive
- Follow up with the company directly
- If the company is unresponsive, file a complaint with the CPSC
- Consult your healthcare provider or attorney if necessary
How to prevent similar issues
- Ask surgeons to confirm device compatibility before procedures
- Verify recall status before any device implantation or replacement
- Monitor recall notices from manufacturers and FDA for medical devices
- Keep records of device lot numbers and reference numbers for future recalls
Documentation advice
Keep the recall letter, photograph model/reference numbers, and all correspondence with the provider and manufacturer
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Product Details
Product: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference numbers: 354-9113, 354-9313, 354-9314 Style: SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc) Brand: Mentor Texas LP Distribution: Worldwide, including US nationwide and many countries Recall date: 2026-02-18 Model numbers: 00081317006671, 00081317006794, 00081317006800 Hazard: Infusion sets may contain dull/blunt needle tips that may be difficult to advance or break Remedy: Stop using the device and follow recall instructions from the manufacturer Notified by: Letter
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: Mentor Texas LP
- Product: CPX 4 US Breast Tissue Expanders with Suture Tabs
- Hazard: dull/blunt needle tip in infusion sets; may be difficult to advance or break; HIGH hazard
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