FDA recall Z-2239-2026

Product

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Singapore.

Key facts

Status

Ongoing

Initiation date

2026-04-24

Report date

2026-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2239-2026