# FDA recall Z-1124-2022

> **Devicor Medical Products Inc** · Class II · device recall initiated 2022-03-30.

## Product

HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4

## Reason for recall

Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label  incorrectly identifies the product as 4010-05-08-T3.

## Distribution

US Nationwide distribution in the states of DE, KY, NY, OH, WV.

## Key facts

- **Recall number:** Z-1124-2022
- **Recalling firm:** Devicor Medical Products Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-30
- **Report date:** 2022-06-01
- **Termination date:** 2024-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cincinnati, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1124-2022

## Citation

> AI Analytics. FDA recall Z-1124-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1124-2022. Source: US FDA. Licensed CC0.

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