Olympus Corporation of the Americas recalled 103,731 units of the ViziShot 2FLEX aspiration needle on August 6, 2025. The recall stems from a risk of undetected, deformed a-traumatic tips that could affect patient safety. The product is distributed worldwide, including the US, Australia, and Germany.
Potential for undetected, deformed a-traumatic tips.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the ViziShot 2FLEX aspiration needle, model number NA-U403SX-4019. It consists of a handle, sheath, needle, and removable stylet. The device was sold globally between August 4, 2022, and April 25, 2025.
The device poses a high hazard risk due to the potential for undetected, deformed a-traumatic tips. This defect could lead to serious complications during medical procedures.
There are no specific reports of incidents or injuries associated with this recall. The recall follows a precautionary measure due to the potential risks identified.
Patients and healthcare providers should stop using the ViziShot 2FLEX immediately. Follow the recall instructions provided by Olympus and contact your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas or visit their website. Additional recall details are available at the FDA website.
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