CLASS I ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report

ViziShot 2FLEX recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling ViziShot 2FLEX, distributed nationwide in the US. The recall was initiated on 6 Aug 2025 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel Number: NA-U403SX-4019. UDI-DI: 00821925043060. Lot numbers: All lots manufactured after 7/29/2022.

Quantity recalled104,508 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2484-2025
FDA event ID: 97303
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class I
Status: Ongoing
Recall initiated: 6 Aug 2025
FDA classified: 5 Sep 2025
Reported: 17 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Syringes & Needles

Timeline

6 Aug 2025	Recall initiated by company
5 Sep 2025	Classified by FDA	+30 days
17 Sep 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for undetected, deformed a-traumatic tips.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.

Nationwide

Questions about this recall

Why was it recalled?

Potential for undetected, deformed a-traumatic tips.

Which lots are affected?

Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. Lot numbers: All lots manufactured after 7/29/2022.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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