Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36471 |
| Brand Name: | Side-notch biopsy gun, single-use |
| Model: | Brevera Breast Biopsy System Disposable 9 Gauge Needle |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Hologic (Australia and New Zealand) Pty Ltd c/o Logical Freight Solutions NZ Ltd Unit 8/113 Pavilion Drive Airport Oaks Auckland 2022 |
| Contact Information: | |
| Manufacturer: | Hologic Inc |
| Issue: | 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. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 14/1/2026 |
