FDA Medical devices recall ·
Brevera Breast Biopsy System Disposable 9 Gauge Needle recall
- Recall number
- Z-1314-2026
- Date
- (initiated December 15, 2025)
- Company / brand
- Hologic, Inc
250 Campus Dr, Marlborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 681,870 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Why was it recalled?
Presence of particulates in affected devices that can be deposited into breast tissue during use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1314-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.