Devicor Medical Products Inc recalls HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Recall date

April 24, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2239-2026

FDA classification

Class II

Brand / firm

Devicor Medical Products Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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