FDA Device recall Z-1041-2023
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
- FDA Device
- Class II
- terminated
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of Mammotome MammoStar Biopsy Site Identified, REF STAR1401 by Carbon Medical Technologies, citing 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 sha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1041-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-12-16 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carbon Medical Technologies |
| Distribution | US |
Product
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
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.
Identifiers
| code_info | UDI/DI 00858015005431, Lot Number 2201011A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1041-2023%22
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