FDA DeviceClass IINotable

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

Date: 2026-06-03
Brand: Devicor Medical Products Inc
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

1910 units

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