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

Class II
Recalling firm
Devicor Medical Products Inc
Reason for recall
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Affected products (lot / model / serial)
Lot Number: F12607207D
Units affected
1910 units
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Firm location
Cincinnati, OH, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2239-2026
Recall initiated
April 24, 2026
FDA classification date
May 27, 2026
FDA report date
June 3, 2026
FDA event ID
98843
Last updated on HTM Vibe
July 23, 2026
View on openFDA