FDA Device recall Z-2484-2025
ViziShot 2FLEX. Single Use Aspiration Needle
- FDA Device
- Class I
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class I recall of ViziShot 2FLEX. Single Use Aspiration Needle by Olympus, citing potential for undetected, deformed a-traumatic tips.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2484-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-08-06 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Olympus |
| Distribution | US |
Product
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Reason
Potential for undetected, deformed a-traumatic tips.
Identifiers
| code_info | Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. Lot numbers: All lots manufactured after 7/29/2022. |
|---|
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-2484-2025%22
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