FDAHealthApril 24, 2026
Devicor Medical Products Inc — HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
⚠️ Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 24, 2026
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
What's affected?
- Product
- HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- Lot code
- F12607207D
Additional details
Lot Number: F12607207D
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1910 units.
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