# FDA recall Z-2239-2026

> **Devicor Medical Products Inc** · Class II · device recall initiated 2026-04-24.

## Product

HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3

## Reason for recall

Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Singapore.

## Key facts

- **Recall number:** Z-2239-2026
- **Recalling firm:** Devicor Medical Products Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-24
- **Report date:** 2026-06-03

- **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-2239-2026

## Citation

> MORVS. FDA recall Z-2239-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2239-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*