Z-2239-2026 Class II Ongoing

Recalled by Devicor Medical Products Inc — Cincinnati, OH

Recall Details

Product Type
Devices
Report Date
June 3, 2026
Initiation Date
April 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1910 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot Number: F12607207D