Class II — Hologic, Inc
| Recalling firm | HOLOGIC, INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
| Product | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. |
| Quantity | 681,870 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2025-12-15 |
| Classified | 2026-02-06 |
| Recall number | Z-1314-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hologic, Inc (Z-1314-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98172/
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