---
title: "Olympus: ViziShot 2 FLEX (19G) EBUS -TBNA needles — FDA announcement Jan 16, 2026 | Is It on Recall"
description: "Device & Drug Safety - Defect"
url: https://isitonrecall.com/recall/fdapress-60e2008c315a6aaa-olympus-vizishot-2-flex-19g-ebus-tbna-needles/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Olympus: ViziShot 2 FLEX (19G) EBUS -TBNA needles — FDA announcement Jan 16, 2026

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jan 16, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: ViziShot 2 FLEX (19G) EBUS -TBNA needles
- **Reason**: Device & Drug Safety - Defect
- **Classification**: Not supplied
- **Recalling firm**: Olympus Corporation
- **Quantity**: Not supplied
- **Agency-reported status**: Company recall announcement
- **Source record identifier**: 60e2008c315a6aaa

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-expands-voluntary-recall-vizishot-2-flex-19g-ebus-tbna-needles)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Not supplied |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Jan 16, 2026
- **Company announcement date**: Jan 16, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Users are directed to cease use immediately and quarantine all ViziShot 2 FLEX devices. Customers have been instructed to return the affected devices to Olympus by following the instructions provided in the removal action communication. Patient safety is our top priority.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-expands-voluntary-recall-vizishot-2-flex-19g-ebus-tbna-needles)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Olympus Corporation records](https://isitonrecall.com/brand/olympus-corporation/)