medical MODERATE Updated 2026-04-08

Mentor Texas, LP. recalls CPX 4 US Breast Tissue Expanders with Suture Tabs Reference

See all recalls from Mentor Texas, LP. →

Recalled Product

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)

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 00081317006671 00081317006794 00081317006800

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for CPX 4 US Breast →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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