Brevera Breast Biopsy System Disposable 9 Gauge Needle — Class II medical device recall Z-1314-2026
Ongoing recall by Hologic, Inc, reported 2026-02-18, distributed nationwide. Presence of particulates in affected devices that can be deposited into breast tissue during use.
| Recall number | Z-1314-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2025-12-15 |
| Classified | 2026-02-06 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 681,870 units |
| Reason classes | specification failure |
| Model numbers | BREVDISP09 |
Product
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Reason for recall
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1314-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.