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Z-2239-2026Class II

Devicor Medical Products Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Devicor Medical Products Inc
Product type
Device
Status
Ongoing
Report date
2026-06-03
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Firm state
OH
Product quantity
1910 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

Product description

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

Code / lot info

Lot Number: F12607207D

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →