Mentor Texas LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs on February 18, 2026. Infusion sets may have dull or blunt needle tips that can be difficult to advance or break. Health facilities and patients should stop using the device immediately and follow the recall instructions.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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
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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.
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.
This recall is not indicated as part of a broader industry pattern in the provided information.
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.
Recall letter from Mentor Texas LP and the FDA recall notice at enforce_rpt-Product-Tabs.cfm?recall_number=Z-1681-2026
Remedy and replacement/reimbursement will be communicated by letter; expect several weeks to process after submission
Keep the recall letter, photograph model/reference numbers, and all correspondence with the provider and manufacturer
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
No injuries or incidents have been reported.
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