Official recall notice

FDA DeviceClass IINotable

FDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 S

Recall date
2026-04-08
FDA class
Class II

Why it was recalled

Hazard

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

Product description

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

Verify with the official notice →
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