Mentor Texas LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs sold worldwide, including US nationwide, after determining infusion sets may contain a dull needle tip. The defect may hinder needle advancement or cause breakage during use. Patients and providers should stop using the device immediately and follow recall instructions from the manufacturer.
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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Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Product: CPX 4 US Breast Tissue Expanders with Suture Tabs Sizes: 350cc, 450cc, 650cc, 750cc Brand: Mentor Texas, LP Sold worldwide: US nationwide and numerous countries Recall Date: 2026-02-18 Status: Active UDI: 10081317028427, 10081317028434, 10081317028458, 10081317028465
Infusion sets may contain a dull or blunt needle tip, which may be difficult to advance and may break during use.
No injuries or incidents have been reported.
1. Stop using the product immediately. 2. Contact Mentor Texas, LP or your healthcare provider for instructions. 3. Follow the recall notification for next steps provided by the manufacturer. 4. If you are a clinician, consult your hospital’s risk management and coordinate with the surgeon. 5. Await recall remedy instructions and potential refunds/replacements.
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