Olympus ViziShot 2FLEX Needle Recall: Deformed Tips Risk
Olympus recalls ViziShot 2FLEX tissue biopsy needles (model NA-U403SX-4019) due to potential undetected deformed tips. Affected units were made after July 29, 2022. Consumers should check model numbers and lot dates.
Lower-risk recall
Potential for undetected, deformed a-traumatic tips.
Contact the company
What happened, in plain English
Olympus is recalling ViziShot 2FLEX single-use aspiration needles because they may have deformed tips that aren't detected during use. This could lead to injury if the needle doesn't function properly. The recall affects needles made after July 29, 2022. Read more at govinfonow.com/recall/51669-olympus-vizishot-2flex-needle-recall-deformed-tips-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/51669-olympus-vizishot-2flex-needle-recall-deformed-tips-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2484-2025
Cite this page
“Olympus ViziShot 2FLEX Needle Recall: Deformed Tips Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51669-olympus-vizishot-2flex-needle-recall-deformed-tips-risk. Based on FDA recall #Z-2484-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2484-2025%22&limit=1).
Why it’s dangerous
The needle tips may become deformed during manufacturing without being detected. This could cause the needle to malfunction during use, potentially leading to injury if it doesn't properly penetrate tissue.
Who’s affected
Medical professionals using the ViziShot 2FLEX needle for tissue biopsies are most at risk. The recall applies to all units manufactured after July 29, 2022.
How to tell if you have this one
Check for model number NA-U403SX-4019 on the needle packaging. The recall covers all units made after July 29, 2022. The lot number is listed on the packaging.
- Brand
Olympus- Category
Medical device
What to do — step by step
Check Model Number
Look for model number NA-U403SX-4019 on the needle packaging.
Verify Production Date
Ensure the needle was manufactured after July 29, 2022.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2484-2025 (August 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2484-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.