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.
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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Artoura Breast Tissue Expanders are medical devices used in breast reconstruction to prepare for future implant placement.
A dull needle tip in the infusion set can hinder administration and may risk a break, potentially affecting treatment.
Unknown; this recall notice does not state whether it is part of a broader industry pattern.
The recall could affect patients undergoing reconstruction who rely on timely infusion therapy. Immediate cessation and provider guidance are required.
UDI labels on device packaging and labeling materials; recall notice provides reference numbers
No specific timeline for refunds or replacements is provided in the recall notice
Keep the recall notice, device labeling, purchase records, and all communications with providers and the manufacturer
Product: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH, SDC-110UH, SDC-120UH, SDC-130UH, SDC-135UH, SDC-140UH UDIs: 10081317028182, 10081317028205, 10081317028212, 10081317028229, 10081317028236, 10081317028281 Sizes: 350cc, 455cc, 535cc, 650cc, 700cc, 850cc Brand/Manufacturer: Mentor Texas, LP Distribution: Worldwide, including US nationwide and numerous countries Sold by: Mentor Texas, LP 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 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.
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.