# FDA recall Z-1170-2025

> **Hologic, Inc** · Class II · device recall initiated 2025-01-15.

## Product

Brand Name: Sertera Biopsy Device  Product Name: Sertera Biopsy Device  Model/Catalog Number: Sertera-14  Software Version: N/A  Product Description: Instrument, Biopsy  Component: N/A

## Reason for recall

Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

## Distribution

Domestic: Nationwide Distribution

## Key facts

- **Recall number:** Z-1170-2025
- **Recalling firm:** Hologic, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-15
- **Report date:** 2025-02-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1170-2025

## Citation

> AI Analytics. FDA recall Z-1170-2025. Retrieved 2026-09-15 from https://api.ai-analytics.org/recall/Z-1170-2025. Source: US FDA. Licensed CC0.

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