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Devicor Medical Products Inc: HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

Medical DevicesSource: FDA (device) · Date: 2026-06-03

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Devicor Medical Products Inc
Product
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Reason / hazard
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Recall initiated
2026-04-24
Code info
Lot Number: F12607207D
Product quantity
1910 units
Voluntary mandated
Voluntary: Firm initiated
City
Cincinnati
State
OH
Country
United States
Event id
98843
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