FDA-Device2026-06-03Class IIMISBRANDING
Devicor HydroMARK breast biopsy markers recalled for incorrect inner package labeling
What this means
Devicor Medical Products is recalling HydroMARK Breast Biopsy Site Marker Model 4010-02-15-T3 due to incorrect labeling on individual packages inside boxes. Some boxes labeled as T3 markers may contain packages labeled as T4 markers, which could lead to use of the wrong marker type during a breast biopsy procedure.
- Check boxes of affected markers (Model 4010-02-15-T3, Lot F12607207D) against the inner package labels before use.
- Verify that individual packages match the box labeling.
- Contact Devicor Medical Products if you have affected units and need guidance on next steps.
The agency's original wording
Hazard
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Singapore.
Affected count
1910 units
Manufactured in
300 E Business Way Fl 5, Cincinnati, OH, United States
Products
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2026Want us to check the next one for you?
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