Recall Z-1314-2026 ยท KNW Instrument, Biopsy
Hologic, Inc
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
| Date | Feb 6, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| 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 |
| Quantity | 681,870 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163052 | Brevera Biopsy System with Corlumina Imaging Technology Hologic, Inc., Mar 29, 2017 |