Recall Z-2239-2026— Devicor Medical Products Inc
Class II · Ongoing
Class II FDA medical device recall by Devicor Medical Products Inc, initiated 2026-04-24. It names one FDA 510(k) clearance: K212158. Product: HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3. Reason: Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers..
- Recalling firm
- Devicor Medical Products Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-24
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.