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 | Terminated |
| Reason | Incorrect label on the Sertera Biopsy Kit |
| Product | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. |
| Quantity | 570 units |
| Distribution | Nationwide. |
| Initiated | 2016-08-22 |
| Classified | 2016-09-21 |
| Terminated | 2017-02-03 |
| Recall number | Z-2869-2016 |
| 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-2869-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74989/
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