FDA Enforcement
Class II
Ongoing
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Recall: Z-2239-2026
·
Reported June 3, 2026
Enforcement
- Recall Number
- Z-2239-2026
- Event ID
- 98843
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Devicor Medical Products Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 3, 2026
- Initiation Date
- April 24, 2026
- Classification Date
- May 27, 2026
- Address
- 300 E Business Way Fl 5, Cincinnati, OH, 45241-2384, United States
Description
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Reason
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Code Info
Lot Number: F12607207D
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Quantity
1910 units