Class II — Carbon Medical Technologies, Inc.
| Recalling firm | Carbon Medical Technologies, Inc. |
|---|---|
| Registered facility | CARBON MEDICAL TECHNOLOGIES, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle. |
| Product | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 |
| Quantity | 550 devices |
| Distribution | US Nationwide distribution in the state of OHIO. |
| Initiated | 2022-12-16 |
| Classified | 2023-01-30 |
| Terminated | 2023-08-09 |
| Recall number | Z-1041-2023 |
| 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 — Carbon Medical Technologies, Inc. (Z-1041-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91419/
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