CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissu
FDA device recall Z-1681-2026 · posted 2026-03-27 · Open, Classified
Recall details
- Recalling firm
- Mentor Texas, LP.
- Reason for recall
- Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LCJ
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Albania, Australia, Austria, Belgium, Bulgaria, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Norway, Pakista
- Date initiated
- 2026-02-18
- Date posted
- 2026-03-27
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS (K130813) | Mentor Corp. | 2013-04-11 |