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.
Reported: September 17, 2025 Initiated: August 6, 2025 #Z-2484-2025
Product Description
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.
Reason for Recall
Potential for undetected, deformed a-traumatic tips.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 103,731 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Olympus Corporation of the Americas. Units affected: 103,731 units.
Why was this product recalled? ▼
Potential for undetected, deformed a-traumatic tips.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2025. Severity: Critical. Recall number: Z-2484-2025.
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