This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

• Product Name: ViziShot 2 FLEX (19G) 
• Unique Device Identifier (UDI): 00821925043060
• Lot Numbers: Full list of affected devices. Distributed August 4, 2022, to April 25, 2025, with expiration date March 25, 2028, or earlier.

What to Do

• Do not use any ViziShot 2 FLEX (19G) devices from affected lots.
• Review and be aware of existing warnings included in the device instructions for use (IFU).

On August 6, 2025, Olympus sent all affected customers an Urgent Medical Device Removal letter recommending the following: 

• Do not use any ViziShot 2 Flex (19G) devices with a lot number listed in Attachment 1. 
• Olympus is also reinforcing existing warnings from the IFU, including: 
  • Warnings from Section 11 of the current IFU, ref: PN0008807_AH) for all users of the ViziShot 2 FLEX (19G).
    • If you feel excessive resistance while operating the needle, do not push the needle slider forcibly.
    • Do not force the instrument if resistance to insertion is encountered. Confirm the endoscope is straight and in the neutral position. Attempting to force the instrument could cause patient injury, such as perforation, bleeding, or mucous membrane damage. It could also damage the endoscope and/or the instrument.
  • Cautions and warnings from Section 6 and Section 11 of the IFU:
    • If using the same instrument several times during an operation, confirm there is no irregularity of the instrument before inserting it into the endoscope.
    • Prepare and inspect the instrument as instructed [in Section 11], should any irregularity be observed, do not use the instrument; use a spare instead. Damage or irregularity may compromise patient or user safety, such as posing an infection control risk causing tissue irritation, perforation, bleeding, or mucous membrane damage, and may result in more severe equipment damage.
    • Do not use an aspiration needle that has an irregularly bent or deformed needle tube.
• Actions Required:
  • If resistance is encountered, do not continue using the device and do not forcibly attempt to insert the device or push the needle slider forcibly.
  • Confirm the device is free of any irregularity after each pass.
  • Do not continue to use a device with any irregularity or deformity. In the event a device from an affected lot number was inadvertently used, ensure the device is inspected after use for any damage or missing components.
  • Examine inventory and quarantine any identified devices with the affected lot numbers. 
  • Ensure all users of the device carefully read the notification, including the reinforced text from the IFU and the product removal information.
  • Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will issue a credit to the facility upon return of affected product(s).
  • Acknowledge receipt of the letter through the Olympus web portal:
    • Enter the recall number "0473.”
    • Complete the form as instructed.
  • Forward this notification to any customers who may have received this product.

Reason for Recall

Olympus is recalling certain ViziShot 2 FLEX (19G) products due to a potential patient safety issue caused by a potentially deformed a-traumatic tip. Devices manufactured before May 12, 2025, with this defect could cause hypotube component ejection and/or detached plastic components, both of which could enter the airways of the lungs (tracheobronchial tree) and require intervention for removal.

The use of affected product may cause serious adverse health consequences, including mucosal injury and bleeding from loose components entering the tracheobronchial tree or additional procedures for removal, infection, and death.

There have been 14 reported injuries and one death related to this issue.

Device Use

The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. It is designed for use with ultrasound endoscopes for ultrasound guided fine needle aspiration and fine needle biopsy of abnormal structures under the mucosal layer (submucosal) or originating outside (extramural) of the tracheobronchial tree.

Contact Information

Customers in the U.S. with questions about this recall should contact Olympus Customer Service at 1-800-848-9024, option 2.

Additional FDA Resources  

Additional Company Resources

Company provided information on a recall is posted here by the FDA as a public service.

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.  

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.