Mammotome MammoStar Biopsy Site Identified — Class II medical device recall Z-1041-2023
Terminated recall by Carbon Medical Technologies, Inc., reported 2023-02-08, distributed nationwide. The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gau
| Recall number | Z-1041-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carbon Medical Technologies, Inc., Saint Paul, MN, United States |
| Recall initiated | 2022-12-16 |
| Classified | 2023-01-30 |
| Reported by FDA | 2023-02-08 |
| Terminated | 2023-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 550 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00858015005431 |
| Lot numbers | 2201011A |
| Model numbers | TAR1401 |
Product
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Reason for recall
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.
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-1041-2023. 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.