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.
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 textured implants used in breast reconstruction to create space for future implants. They are designed to gradually stretch tissue after mastectomy or lumpectomy and are selected by surgeons in consultation with patients.
A dull needle tip in infusion sets can hinder the injection process and may break, creating a risk of incomplete administration or instrument failure.
This recall is not cited as part of a broader industry pattern in the provided notice.
Patients may experience delays in reconstruction, additional clinical visits, and potential changes to planned treatment timelines. The recall could entail logistical and financial implications for affected patients.
Refer to the FDA recall page for Z-1685-2026 and contact Mentor Texas, LP. for instructions.
Recall remedies typically involve replacement or guidance within weeks to a couple of months; follow manufacturer timelines in the recall letter.
Save all recall notices, letters, and communications. Take photos of device labels and UDIs. Note dates of any clinical interactions related to the device.
Product: Artoura Breast Tissue Expanders. Reference numbers: TEXP110RH, TEXP120RH, TEXP120RUH, TEXP130RH, TEXP135RH, TEXP140RH, TEXP150RH. Textured, high and ultra high profile with integral injection dome. Capacities listed as 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc. Manufacturer: Mentor Texas, LP. Distribution: Worldwide, including US nationwide and countries listed in the recall.
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 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.