ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is
FDA device recall Z-2484-2025 · posted 2025-09-05 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential for undetected, deformed a-traumatic tips.
- 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.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- KTI
- Quantity affected
- 104,508 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
- Date initiated
- 2025-08-06
- Date posted
- 2025-09-05
- Location
- Center Valley, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ViziShot 2 FLEX (K193517) | Olympus Surgical Technologies America | 2020-03-18 |