Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
FDA Recall Z-1314-2026 · Posted 2026-02-06
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Recalling FirmHologic, Inc
Recall StatusOpen, Classified
Product CodeKNW
Date Initiated2025-12-15
Product Quantity681,870 units
Reason for Recall
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Firm Action
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 [email protected] 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 [email protected] or by phone at 1-877-371-4372.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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