CLASS II ONGOING Device recall · Reported 18 Feb 2026 · FDA Enforcement Report
Brevera Breast Biopsy System Disposable Needle recalled by Hologic
Hologic is recalling Brevera Breast Biopsy System Disposable Needle, distributed nationwide in the US. The recall was initiated on 15 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1314-2026
- FDA event ID
- 98172
- Recalling firm
- Hologic, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Dec 2025
- FDA classified
- 6 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Syringes & Needles
Timeline
| 15 Dec 2025 | Recall initiated by company | |
| 6 Feb 2026 | Classified by FDA | +53 days |
| 18 Feb 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Product as listed by the FDA
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Which lots are affected?
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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