Class II

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

Devicor Medical Products Inc · April 24, 2026

Reason for Recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Singapore.

States Affected

NATIONWIDE

Quantity Affected

1910 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2239-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Devicor Medical Products Inc Medical Device Recall: HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | SafeCheck