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.
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 breast reconstruction to create space for subsequent implants. They are gradually filled to stretch tissue.
A dull or blunt infusion needle tip may hinder infusion and could break, potentially compromising the reconstruction procedure.
This recall is not described as part of a broader industry pattern.
The recall affects patients undergoing breast reconstruction. Stopping use requires medical guidance and potential device replacement, which may affect treatment timelines and costs.
Manufacturer recall notice and FDA enforcement page list identification codes and steps. The FDA page linked in the recall provides official details.
4-8 weeks for refunds or replacements, depending on supplier and surgeon coordination.
Keep recall notice, correspondence with manufacturer, surgeon notes, and photos of device labels.
Product: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference numbers: SCPX-157LH Model: Smooth Low Height Tissue Expander, 650cc Sold worldwide, including US nationwide Countries involved: Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakistan, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Czech Republic Price: Unknown
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 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 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.