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 | Ongoing |
| Reason | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
| Product | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 |
| Quantity | 1910 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Singapore. |
| Initiated | 2026-04-24 |
| Classified | 2026-05-27 |
| Recall number | Z-2239-2026 |
| 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-2239-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98843/
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