FDA Device recall Z-1124-2022
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
- FDA Device
- Class II
- terminated
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 by Devicor Medical Products, citing small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1124-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-30 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Devicor Medical Products |
| Distribution | US |
Product
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Reason
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
Identifiers
| code_info | UDI-DI: 00841911102472 Lot F12201281D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1124-2022%22
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