Hologic, Inc: Medical Device Recall in 2026 - (Recall #: Z-1314-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 15, 2025

Date Posted: February 18, 2026

Recall Number: Z-1314-2026

Event ID: 98172

Reason for Recall:

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

Status: Ongoing

Product Quantity: 681,870 units

Code Information:

Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated