The Recall Desk
HighFDA (Devices)·Z-1681-2026·Announced 2026-04-08

CPX 4 SILTEX low height expander infusion needles may be blunt

Mentor is recalling CPX 4 US Breast Tissue Expanders with Suture Tabs in the SILTEX low height range because the infusion sets may contain a dull or blunt needle tip.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a needle that may break or fail to advance during a procedure is a hazard, and no injuries are stated in the source.

Plain-English summary

CPX 4 US Breast Tissue Expanders with Suture Tabs, SILTEX low height, reference numbers 354-9113, 3549313 and 354-9314 in styles 9100 (450 cc) and 9300 (450 cc and 550 cc), are being recalled. The product was distributed nationwide in the United States and to Canada and more than twenty other countries. The FDA has classified this recall as Class II.

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

Affected product carries UDIs 00081317006671, 00081317006794 and 00081317006800.

Facilities can identify affected expanders by the reference number and UDI above, and may contact the recalling firm for further information.

The recalled product

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)
Manufacturer
Mentor Texas, LP.
Category
Medical Device — Tissue expander
Hazard
  • needle-defect
  • device-breakage
  • procedure-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 00081317006671 00081317006794 00081317006800

Distribution

Distributed nationwide across the United States.

Related recalls

Same category