FDA Device recall Z-2239-2026
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
- FDA Device
- Class II
- ongoing
- Published 2026-06-03
On 2026-06-03 the FDA classified a Class II recall of HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 by Devicor Medical Products, citing incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2239-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-24 |
| Published | 2026-06-03 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Devicor Medical Products |
| Distribution | US |
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.
Identifiers
| code_info | Lot Number: F12607207D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2239-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.