HydroMARK Breast Biopsy Marker — Class II medical device recall Z-1124-2022
Terminated recall by Devicor Medical Products Inc, reported 2022-06-01, distributed nationwide. Small patient labels do not match the primary device label. The primary device label accurately identifies the
| Recall number | Z-1124-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Devicor Medical Products Inc, Cincinnati, OH, United States |
| Recall initiated | 2022-03-30 |
| Classified | 2022-05-23 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2024-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 90 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00841911102472 |
| Lot numbers | F12201281D |
| Model numbers | 4010-05-08-T4 |
Product
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1124-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.