FDA-Device2026-02-18Class IIPROCESSING DEFECT
Hologic Brevera 9 Gauge biopsy needle recalled for particulate contamination risk
What this means
Hologic's Brevera Breast Biopsy System disposable 9 gauge needles may contain tiny particles that could be deposited into breast tissue during a biopsy procedure. This affects approximately 681,870 units distributed nationwide. No injuries have been reported so far.
- If you use this device in a medical facility, stop using affected needles immediately
- Check your inventory for Model No. BREVDISP09 with UDI 1540045512863
- Contact Hologic or your device supplier for instructions on affected lots and replacements
- Consult with your healthcare provider if you have had a recent biopsy with this needle
The agency's original wording
Hazard
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
681,870 units
Manufactured in
250 Campus Dr, N/A, Marlborough, MA, United States
Products
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1314-2026Want us to check the next one for you?
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