Official recall notice

FDA DeviceClass IINotable

HydroMARK Breast Biopsy Site Marker Recall (Jun 2026)

Product: HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Recall date
2026-06-03
FDA class
Class II

Why it was recalled

Hazard

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

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Product description

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

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