FDA recall Z-1314-2026

Product

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Reason for recall

Presence of particulates in affected devices that can be deposited into breast tissue during use.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2025-12-15

Report date

2026-02-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1314-2026