Mentor Texas recalls CPX 4 US Breast Tissue Expanders with Suture Tabs (reference numbers 354-9113, 3549313, 354-9314) due to potential needle breakage during use.
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Mentor Texas is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs because the infusion sets may contain dull or blunt needle tips that could be difficult to advance or break. This could lead to complications during medical procedures.
The infusion sets used with these expanders may have dull or blunt needle tips. This can make it harder to advance the needle during medical procedures and increase the risk of the needle breaking, potentially causing complications.
Patients who have received the CPX 4 US Breast Tissue Expanders with Suture Tabs (reference numbers 354-9113, 3549313, 354-9314) are affected. Medical professionals using these expanders for breast tissue procedures are most at risk.
Check for reference numbers 354-9113, 3549313, or 354-9314 on the expanders. These are SILTEX Low Height Tissue Expanders with Suture Tabs (9100, 450cc; 9300, 450cc; 9300, 550cc).
Look for reference numbers 354-9113, 3549313, or 354-9314 on the expanders.
The infusion sets may contain dull or blunt needle tips that could be difficult to advance or break during medical procedures.
The recall record does not specify a remedy or action steps for affected users.
Yes, the reference numbers 354-9113, 3549313, and 354-9314 are associated with this recall.
We’ve drafted a message you can send Mentor Texas to request your refund or repair — edit it as you like.
Subject: Recall Z-1681-2026 — Mentor Texas Mentor Texas Hello, I own a Mentor Texas that is covered by recall Z-1681-2026 from Mentor Texas. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
