HydroMARK Breast Biopsy Site Marker — Class II medical device recall Z-2239-2026
Ongoing recall by Devicor Medical Products Inc, reported 2026-06-03, distributed nationwide. Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled
| Recall number | Z-2239-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Devicor Medical Products Inc, Cincinnati, OH, United States |
| Recall initiated | 2026-04-24 |
| Classified | 2026-05-27 |
| Reported by FDA | 2026-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SG |
| Quantity | 1,910 units |
| Reason classes | labeling |
| Lot numbers | F12607207D |
| Model numbers | 4010-02-15-T3 |
Product
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Reason for recall
Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
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-2239-2026. 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.