Z-2484-2025Class I

ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy...

Name: Z-2484-2025 ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy...
Creator: Olympus Corporation of the Americas
Published: 2025-08-06
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-08-06 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of 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... on 2025-08-06. FDA classified it as Class I and gives the reason as "Potential for undetected, deformed a-traumatic tips". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2484-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-08-06
Posted: 2025-09-05
Recalling firm: OLYMPUS Corporation of the Americas
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.
Product code: KTI Bronchoscope Accessory
Reason for recall: Potential for undetected, deformed a-traumatic tips.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 104,508 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
Product codes and lots: Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. Lot numbers: All lots manufactured after 7/29/2022.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2484-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2484-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-05

Product code KTI

K193517Class IIViziShot 2 FLEXOlympus Surgical Technologies America / cleared 2020-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)