# FDA recall Z-1041-2023

> **Carbon Medical Technologies, Inc.** · Class II · device recall initiated 2022-12-16.

## 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.

## Distribution

US Nationwide distribution in the state of OHIO.

## Key facts

- **Recall number:** Z-1041-2023
- **Recalling firm:** Carbon Medical Technologies, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-12-16
- **Report date:** 2023-02-08
- **Termination date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2023

## Citation

> AI Analytics. FDA recall Z-1041-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1041-2023. Source: US FDA. Licensed CC0.

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