Z-1314-2026Class II

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument

Name: Z-1314-2026 Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument
Creator: Hologic, Inc
Published: 2025-12-15
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2025-12-15 / Open, Classified

FDA source

Hologic, Inc began a recall of Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument on 2025-12-15. FDA classified it as Class II and gives the reason as "Presence of particulates in affected devices that can be deposited into breast tissue during use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1314-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-15
Posted: 2026-02-06
Recalling firm: Hologic, Inc.
Product: Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Product code: KNW Instrument, Biopsy
Reason for recall: Presence of particulates in affected devices that can be deposited into breast tissue during use.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 681,870 units
Distribution: US Nationwide distribution.
Product codes and lots: Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1314-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1314-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-06

Product code KNW

K163052Class IIBrevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc. / cleared 2017-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)