Skip to main content
Recall Canary
HydroMARK Breast Biopsy Site Marker
← Back to all recalls
MEDICAL DEVICE RECALLMODERATE

HydroMARK Breast Biopsy Site Marker

Devicor Medical is recalling HydroMARK breast biopsy site markers due to incorrect inner package labeling.

What to do

Check the inner package labeling of your HydroMARK breast biopsy site markers to ensure it matches the outer box labeling. If you identify a discrepancy, contact Devicor Medical Products for further instructions.

Posted
Updated
Recall No.
Z-2239-2026
Agency
Firm
Devicor Medical Products Inc
Recall ID
98843
Status
ONGOING

Why it was recalled

Devicor Medical Products is recalling specific breast biopsy site markers due to incorrect inner package labeling. Boxes labeled as model 4010-02-15-T3 may contain individual packages that are incorrectly labeled as T4 markers.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

HydroMARK Breast Biopsy Site Marker

Model
4010-02-15-T3

Where it was sold

Distributed nationwide.

← Back to all recalls

Editorial summary by Recall Canary · last updated 2026-05-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification