Quick Facts at a Glance
- Recall Date
- August 6, 2025
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus Corporation of the Americas
- Product type
- Tissue Biopsy Device
- Model numbers
- NA-U403SX-4019
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 6, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for undetected, deformed a-traumatic tips.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
The device poses a risk of undetected, deformed atraumatic tips which could compromise biopsy outcomes or cause tissue injury.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate halt of use; potential impact on biopsy procedure safety and need for device replacement in clinical settings.
Practical Guidance
How to identify if yours is affected
- Check the model NA-U403SX-4019 on the device label
- Verify serial numbers with manufacturer documentation
- Refer to FDA recall Z-2484-2025 for instructions
Where to find product info
FDA enforcement recall page linked in official notices; manufacturer communications
What timeline to expect
Recall processing timelines vary; follow Olympus instructions for refunds or replacements, typically weeks
If the manufacturer is unresponsive
- Document all communications with Olympus
- Escalate to hospital risk management or patient safety officers
- File a complaint with FDA if manufacturer does not respond
How to prevent similar issues
- Verify device model before procurement
- Keep recall notices accessible to clinical staff
- Maintain supplier alerts for medical devices
- Follow supplier recommendations for replacements and safer alternatives
Documentation advice
Retain recall notices, correspondences, and replacement receipts; document device lot numbers and usage histories
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Product Details
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.
Reported Incidents
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.
Key Facts
- Model NA-U403SX-4019
- Worldwide distribution including US, Australia, Germany, Canada, Chile, China, Hong Kong, India, and
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Safety Guide
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