FDA Device recall Z-1170-2025
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Descri…
- FDA Device
- Class II
- ongoing
- Published 2025-02-19
On 2025-02-19 the FDA classified a Class II recall of Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Descri… by Hologic, citing devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1170-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-15 |
| Published | 2025-02-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hologic |
| Distribution | US |
Product
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Reason
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Identifiers
| code_info | Model No- Sertera-14; UDI- 15420045504066; Lot Numbers: E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23…Model No- Sertera-14; UDI- 15420045504066; Lot Numbers: E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23D12RU, E23D27RW, E23E03RJ, E23E12RT, E23E12RU, E23E29RL, E23E30RM, E23F02RG, E23F07RL, E23F07RM, E23F27R, E23F29RL, E23F29RM, E23F29RN, E23G12RK, E23G25R, E23G31RL, E23H02R, E23H02RA, E23H02RB, E23H28RA, E23H31RF, E23H31RG, E23K02RL, E23K10R, E23K10RA, E23K10RB, E23K31RU, E23L06RK, E23L10RB, E23L22RV, E23L28RB, E23L28RD, E23M21RV, E24A08RL, E24A08RM, E24A26RD, E24B01RF, E24B07RK, E24B22RC, E24B28R, E24B28RA, E24C07RA, E24C21R, E24D26RF, E24E02RD, E24E15RA, E24E22R, E24E22RA, E24E24RB, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1170-2025%22
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