Official recall notice
FDA DeviceClass IINotable
FDA Recall: HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Recall date
- 2026-06-03
- Category
- Medical Device
- 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.
Recommended action
What to do
1910 units
Product description
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.