FDA Medical Device Recalls (openFDA)
Hologic, Inc: Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Recall number
- Z-1314-2026
- Recalling firm
- Hologic, Inc
- Product
- Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Status
- Open, Classified
- Initiated
- 2025-12-15
- Posted
- 2026-02-06
- Terminated
- not on file
- Reason
- Presence of particulates in affected devices that can be deposited into breast tissue during use.
- 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 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.
- Quantity
- 681,870 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
- 510(k) numbers
- ["K163052"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 1000120743
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28