Recall Z-1314-2026

Reason for recall

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

FDA-determined cause: Under Investigation by firm

Action taken

An URGENT FIELD SAFETY NOTICE (REMOVAL) was mailed to consignees on 1/2/26. The notification instructs consignees to quarantine affected devices and return them through IQVIA per the instructions provided on the Recall Response Form. The recall notification should be forwarded within consignee locations to users and to any facility to which product was further distributed. A copy of the recall notification is to be posted for awareness at consignee locations. Questions can be directed to BreastHealth.Support@hologic.com or by phone at 1-877-371-4372. An updated FIELD TECHNICAL BULLETIN dated May 2026 was distributed to consignees. This technical bulletin provides guidance to healthcare providers on how to utilize the Brevera Breast Biopsy System without the use of the Brevera 9 Gauge Biopsy Needle. Questions can be directed to BreastHealth.Support@hologic.com or by phone at 1-877-371-4372.