Recall Z-1681-2026 ยท LCJ Tissue Expander And Accessories
Mentor Texas, LP.
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)
| Date | Mar 27, 2026 (initiated Feb 18, 2026) |
| Status | Open, Classified |
| Reason | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. |
| Root cause | Under Investigation by firm |
| Action | 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 assista |
| Distribution | Worldwide distribution - US Nationwide and the countries of 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, Tai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS Mentor Corp., Apr 11, 2013 |