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-
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 during reconstruction to create space for a future implant. They come in various sizes and are attached via sutures. This recall concerns CPX 4 US models with suture tabs.
A dull needle tip in infusion sets can be hard to advance or may break, potentially complicating procedures.
This recall is not part of a broader industry pattern.
The recall requires immediate stoppage of device use and follow-up with the physician for monitoring and guidance on replacement or alternative options.
FDA enforcement page for recall Z-1683-2026; manufacturer notification letters.
Refunds or replacements are typically processed within 4-8 weeks after confirmation.
Keep recall letters, purchase records, device serial numbers, and all correspondence with the manufacturer.
Brand: Mentor Texas, LP. Models: SCPX-107MH, SCPX-117MH, SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH. Description: CPX 4 US Breast Tissue Expander with Suture Tabs. Sizes offered: 275cc, 350cc, 450cc, 550cc, 650cc, 800cc. Sold worldwide, including US nationwide and the listed countries. Price: Not disclosed. Note: Inner model numbers include 10081317028359, 10081317028366, 10081317028373, 10081317028380, 10081317028397, 10081317028403 (internal codes). Recall date: 2026-02-18. Status: Active.
No injuries or incidents have been reported.
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Mentor Texas, LP recalled Artoura Breast Tissue Expanders sold worldwide, including the United States. The infusion sets may contain a dull or blunt needle tip, which may be difficult to advance or break. Healthcare providers and patients should stop using the affected devices and await recall instructions by letter.
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 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.
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.