Olympus Corp of the Americas recalled 103,731 ViziShot 2FLEX single-use aspiration needles worldwide after officials flagged potential undetected, deformed atraumatic tips. The recall covers the NA-U403SX-4019 model. Healthcare providers must halt use immediately and follow manufacturer instructions for recall. Manufacturers say notification was by letter.
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 ViziShot 2FLEX is a single-use aspiration needle used in tissue biopsy procedures. It comprises a handle, sheath, needle and removable stylet. It is intended for professional medical use.
The device poses a risk of undetected, deformed atraumatic tips which could compromise biopsy outcomes or cause tissue injury.
This recall is not described as part of a broader industry pattern in the provided data.
Immediate halt of use; potential impact on biopsy procedure safety and need for device replacement in clinical settings.
FDA enforcement recall page linked in official notices; manufacturer communications
Recall processing timelines vary; follow Olympus instructions for refunds or replacements, typically weeks
Retain recall notices, correspondences, and replacement receipts; document device lot numbers and usage histories
Model: NA-U403SX-4019. Product: ViziShot 2FLEX tissue biopsy device. Parts: handle, sheath, needle, stylet. Sold worldwide including US, Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore. Status: Active recall dated 2025-08-06; report dated 2025-09-17.
No specific injuries or incidents are detailed in the provided data. This section notes the hazard and class I classification but does not enumerate injuries.
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