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Official recall record

HydroMARK™ Breast Biopsy Site Marker

Health Canada — Medical Devices · 2026-05-01 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2026-05-01
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

Devicor Medical Products, Inc. is initiating a voluntary medical device recall for certain HydroMARK™ Breast Biopsy site markers due to incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. Users should immediately remove from use any devices labeled as 4010-02-15-T4 from lot F12607207D.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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