HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
USHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Recalling Firm: Devicor Medical Products Inc
Reason for Recall / Hazard
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Product Description & Identification
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Additional Source Details
| Field | Value |
|---|---|
| City | Cincinnati |
| State | OH |
| Event id | 98843 |
| Address 1 | 300 E Business Way Fl 5 |
| Code info | Lot Number: F12607207D |
| Postal code | 45241-2384 |
| Report date | 20260603 |
| Product type | Devices |
| Product quantity | 1910 units |
| Reason for recall | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260424 |
| Initial firm notification | Letter |
| Center classification date | 20260527 |
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Overview
- Recalling FirmDevicor Medical Products Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Singapore.
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🚨 SAFETY ALERT: Devicor Medical Products Inc - HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 Check if your household is affected: https://therecallfile.com/recalls/hydromark-breast-biopsy-site-marker-model-number-4010-02-15-t3/FDA-Z-2239-2026
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