Recall Z-2484-2025
Olympus Corporation of the Americas · initiated August 6, 2025
Class I – dangerous or defective products that could cause serious health problems or death
Product
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.
Codes / lots: Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. Lot numbers: All lots manufactured after 7/29/2022.
Reason for recall
Potential for undetected, deformed a-traumatic tips.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-2484-2025
- Initiated
- August 6, 2025
- Posted by FDA
- September 5, 2025
- Product code
- KTI – Bronchoscope Accessory
- Quantity
- 104,508 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA