FDA DevicesClass II
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Published: June 3, 2026Recall ID: Z-2239-2026Category: devicesCountry: US
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 |
Overview
- Recalling FirmDevicor Medical Products Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Singapore.