Class II — Devicor Medical Products Inc
| Recalling firm | Devicor Medical Products, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 |
| Quantity | 90 devices |
| Distribution | US Nationwide distribution in the states of DE, KY, NY, OH, WV. |
| Initiated | 2022-03-30 |
| Classified | 2022-05-23 |
| Terminated | 2024-04-30 |
| Recall number | Z-1124-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Devicor Medical Products Inc (Z-1124-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90119/
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