January 17, 2026
Olympus Corporation has expanded its global medical device removal action for ViziShot 2 FLEX (19G) EBUS-TBNA needles, citing continued reports of device components detaching during procedures. The original recall, issued in August 2025, only applied to specific lots of the device.
Key points:
- Olympus is expanding its recall of ViziShot 2 FLEX needles due to reports of device components detaching during procedures.
- The recall affects all lots of the device and supersedes the August 2025 notice.
- Potential consequences of a detached component include the risk of unintended device components within the tracheobronchial tree, requiring bronchoscopic extraction or surgical removal.
In this article:
- Background on the ViziShot 2 FLEX recall
- Cause of the recall and affected lots
- Instructions for users and return procedures
- Frequently Asked Questions
- Conclusion and implications for users
- Disclaimer for professionals
- FDA announcement and link
What led to the ViziShot 2 FLEX recall?
The ViziShot 2 FLEX needles are designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration and fine needle biopsy of submucosal and extramural lesions of the tracheobronchial tree.
However, Olympus received and investigated complaints of device components ejecting or detaching during procedures, including adverse event reports of patient injury and one death.
What is the cause of the recall and which lots are affected?
The complaints included reports of device components detaching due to hypotube component ejection, which can be caused by device heat-shrink material degradation and use errors.
As a result, Olympus is recalling all lots of the ViziShot 2 FLEX needles, superseding the August 2025 notice that only applied to specific lots.
What should users do with the recalled needles?
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.
Frequently Asked Questions
- What is the ViziShot 2 FLEX needle used for?
The ViziShot 2 FLEX needle is designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration and fine needle biopsy of submucosal and extramural lesions of the tracheobronchial tree. - What is the cause of the recall?
The recall is due to reports of device components detaching during procedures, caused by hypotube component ejection, device heat-shrink material degradation, and use errors. - How can I identify affected lots?
Customers can contact the Olympus Technical Assistance Center (TAC) at 1-800-848-9024, Option 1, Monday-Friday between 7:00 AM and 8:00 PM ET, or by email at complaints@olympus.com.
Conclusion and implications for users
The expanded recall of ViziShot 2 FLEX needles underscores the importance of prioritizing patient safety and taking prompt action in response to adverse event reports.
Users are advised to follow the instructions provided by Olympus and return the affected devices as directed.
Disclaimer for professionals
This article is not intended to provide medical or legal advice.
Professionals should consult the FDA announcement and Olympus's instructions for further guidance.
FDA announcement and link
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-expands-voluntary-recall-vizishot-2-flex-19g-ebus-tbna-needles