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Hydromark™ breast biopsy site marker

Official notice

1 May 2026

MediumHealth Canada

An official Health Canada notice concerns Hydromark™ breast biopsy site marker. 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. Published 2026-05-01.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82023

Official notice

2026-05-01

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

F12607207D

Skus

4010-02-15-T3

Other

RA RA-82023

Model Numbers

4010-02-15-T3

Recall Numbers

82023

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Affected products

Product 1

Lot or serial number - F12607207D, Model or catalogue number - 4010-02-15-T3

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Devicor Medical.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

82023

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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