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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Breast tissue expanders are temporary devices used in reconstructive surgery to create space for implants. The CPX 4 line offers suture tabs and comes in several sizes, including 350cc, 450cc, 650cc, and 750cc.
A dull or blunt needle tip in infusion sets can be difficult to advance and may break, potentially complicating procedures or causing tissue injury.
This recall is not presented as part of a broader industry pattern.
Patients may require additional medical procedures and potential delays in reconstruction. The recall emphasizes immediate cessation of use and following manufacturer instructions to mitigate risk.
On device packaging, labeling, and the recall notice from Mentor Texas LP. The FDA recall page provides the enforceable details.
Not specified in recall notice.
Keep the recall letter, device labeling, serial numbers, UDIs, and all communications. Photograph any packaging and store for records.
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
No injuries or incidents have been reported.
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Mentor Texas, LP recalled Artoura Breast Tissue Expanders worldwide after discovery of dull infusion needle tips. The issue may make it difficult to advance the infusion set or cause it to break. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.
Mentor Texas, LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs worldwide on February 18, 2026. The recall covers models SCPX-107MH, SCPX-117MH, SCPX-127MH, SCPX-135MH, SCPX-146MH and SCPX-156MH. Infusion sets may include a dull needle tip that is difficult to advance and may break. Stop using the device and follow recall instructions from the manufacturer, with recall notification by-
Mentor Texas, LP recalled CPX 4 US Breast Tissue Expanders with Suture Tabs sold worldwide, including the US. Infusion sets may have a dull or blunt needle tip that is difficult to advance or may break. Patients and healthcare providers should stop using the device immediately and contact Mentor Texas, LP for instructions.