FDAFDA · Food and drugs·Recall number Z-2239-2026
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Published June 3, 2026 · Recall initiated: April 24, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Devicor Medical Products Inc
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
- Lot
- Lot Number: F12607207D
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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