Reported Sep 17, 2025 · Ongoing
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is…
Olympus Corporation of the Americas
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- ViziShot 2FLEX. Single Use Aspiration Needle
- Model NumberNA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy
- device is made up of four main partsa 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
- Lot codes and dates
- Model NumberNA-U403SX-4019
- UDI-DI00821925043060
- Lot numbersAll lots manufactured after 7/29/2022
- Amount recalled
- 104,508 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential for undetected, deformed a-traumatic tips.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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