Z-2239-2026 Class II Ongoing
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