Side-notch Biopsy Gun, Single-use
- Recalling firm
- Hologic (Australia and New Zealand) Pty Ltd
- Product
- Side-notch biopsy gun, single-use. [Device]. Model: Brevera Breast Biopsy System Disposable 9 Gauge Needle. Affected: All lots
- Reason
- The device is being removed because there is a risk of metal and plastic particles being dislodged from the device during use. An internal review of complaints received had confirmed particles in patient breast tissue and/or tissue sample post-biopsy.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-14
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/bfb2ac46-0397-478d-b3b5-235d467b03e6