FDA Device recall Z-2035-2023
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14 by Hologic, citing the inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2035-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-02 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hologic |
| Distribution | US |
Product
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Reason
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Identifiers
| code_info | UDI-DI: 15420045504066 Lot Number: E22H19RM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2035-2023%22
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