| Date Initiated by Firm | December 15, 2025 |
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| Date Posted | February 06, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1314-2026 |
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| Recall Event ID |
98172 |
| 510(K)Number | K163052 |
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| Product Classification |
Instrument, biopsy - Product Code KNW
|
| Product | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. |
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| Code Information |
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
|
| FEI Number |
1000120743
|
Recalling Firm/
Manufacturer |
Hologic, Inc
250 Campus Dr
Marlborough MA 01752-3020
|
| For Additional Information Contact | Breast Health Customer Support
+1-877-3714372 |
|---|
Manufacturer Reason
for Recall | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Quantity in Commerce | 681,870 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = KNW
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