FDA Device recall Z-2869-2016
Sertera Biopsy Device, Sterile
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of Sertera Biopsy Device, Sterile by Hologic, citing incorrect label on the Sertera Biopsy Kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2869-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-22 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hologic |
| Distribution | US |
Product
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Reason
Incorrect label on the Sertera Biopsy Kit
Identifiers
| code_info | Lot number: 15C10RA. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2869-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.