HIGH

Olympus Recalls ViziShot 2FLEX Needle Over Hazard Risk

Olympus Corporation of the Americas recalled 103,731 units of the ViziShot 2FLEX aspiration needle on August 6, 2025. The recall stems from a risk of undetected, deformed a-traumatic tips that could affect patient safety. The product is distributed worldwide, including the US, Australia, and Germany.

Quick Facts at a Glance

Recall Date
August 6, 2025
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Potential for undetected, deformed a-traumatic tips.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter

Product Details

The recalled product is the ViziShot 2FLEX aspiration needle, model number NA-U403SX-4019. It consists of a handle, sheath, needle, and removable stylet. The device was sold globally between August 4, 2022, and April 25, 2025.

The Hazard

The device poses a high hazard risk due to the potential for undetected, deformed a-traumatic tips. This defect could lead to serious complications during medical procedures.

Reported Incidents

There are no specific reports of incidents or injuries associated with this recall. The recall follows a precautionary measure due to the potential risks identified.

What to Do

Patients and healthcare providers should stop using the ViziShot 2FLEX immediately. Follow the recall instructions provided by Olympus and contact your healthcare provider for further guidance.

Contact Information

For more information, contact Olympus Corporation of the Americas or visit their website. Additional recall details are available at the FDA website.

Key Facts

  • Recall date: August 6, 2025
  • Units recalled: 103,731
  • Distributed worldwide
  • Potential for deformed tips
  • Follow recall instructions immediately
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeAspiration Needle
Sold At
Multiple Retailers

Product Details

Model Numbers
NA-U403SX-4019
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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