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)
FDA Recall Z-1681-2026 · Posted 2026-03-27
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Recalling FirmMentor Texas, LP.
Recall StatusOpen, Classified
Product CodeLCJ
Date Initiated2026-02-18
Reason for Recall
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
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 [email protected] 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
Distribution Pattern
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, Taiwan, United Kingdom, Czech Republic.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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