Mentor Texas, LP. recalls CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113

Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)

On March 2, 2026, Mentor Worldwide LLC issued a updated "Urgent Medical Device Recall (Removal). The initial notification was issued on February 18, 2026. Mentor is asking consignees to take the following actions: 1. Examine your inventory and quarantine immediately any affected products. 2. Please maintain a copy of the notice with the quarantined product. 3. Notify all personnel who need to be made aware of the recall. 4. Complete the Business Reply Form of this notice and fax 877-223-7559 or email ethicon3910@sedgwick.com to Sedgwick within 3 business days. 5. If you require any assistance with returning product, please contact Sedgwick at 877-546-7680 and reference Event # 3910

• FDA enforcement recordOfficial FDA database entry for Z-1681-2026
• FDA 510(k) clearance · K130813The device's official FDA premarket clearance record
• FDA device classification · LCJOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Mentor Texas, LP.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.