ViziShot 2FLEX. Single Use Aspiration Needle. Model Number:… recallZ-2484-2025 · Olympus Corporation of the Americas · initiated Aug 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for undetected, deformed a-traumatic tips.
FDA root cause category: Process design
What the company is doing
Olympus notified consignees on about 08/06/2025 via letter. Consignees were instructed to examine inventory and quarantine any affected units, ensure all users of the device carefully read the content of this notification, including the reinforced text from the IFU and the product removal information, arrange for the return of affected units, and acknowledge receipt of the recall notification via the Olympus web portal. Consignees were also instructed to notify customers if the affected units were further distributed. ***Update 12/31/2025*** URGENT MEDICAL DEVICE RECALL letters were sent to additional customers on January 9, 2026 with identical instructions. ***Edit 3/23/26: January 9, 2026 letters users were instructed to return all affected devices.
Recall details
- Recall number
- Z-2484-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2025
- Posted by the FDA
- Sep 5, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 104,508 units
- Product code
- KTI
- FDA submissions
- K193517
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
Product description
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.
Code information (models, lots, serial numbers)
Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. Lot numbers: All lots manufactured after 7/29/2022.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ViziShot 2 FLEX NA-U403SX-4019Gyrus ACMI, LLC · Bronchoscope accessory1 recall349 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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