Brevera Breast Biopsy System Disposable 9 Gauge Needle.… recallZ-1314-2026 · Hologic, Inc · initiated Dec 15, 2025
Class II Open, Classified All recalls posted in February 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Presence of particulates in affected devices that can be deposited into breast tissue during use.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1314-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Dec 15, 2025
- Posted by the FDA
- Feb 6, 2026
- Recalling firm
- Hologic, Inc
- Quantity
- 681,870 units
- Product code
- KNW
- FDA submissions
- K163052
- Distribution
- US Nationwide distribution.
Product description
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Code information (models, lots, serial numbers)
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Other devices under the same FDA submission
5 devices cleared under K163052 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Brevera Breast Biopsy System BREVDISP09Hologic, Inc. · INSTRUMENT, BIOPSY154 reports
- Brevera Breast Biopsy System BREV100Hologic, Inc. · INSTRUMENT, BIOPSY74 reports
- Brevera Breast Biopsy System BREVDRVHologic, Inc. · INSTRUMENT, BIOPSY61 reports
- Brevera Breast Biopsy System BREV200Hologic, Inc. · INSTRUMENT, BIOPSY7 reports
- Brevera Breast Biopsy System BREV09Hologic, Inc. · INSTRUMENT, BIOPSY4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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