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.
Potential for undetected, deformed a-traumatic tips.
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.
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.
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.
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.
Look for model number NA-U403SX-4019 on the needle packaging.
Ensure the needle was manufactured after July 29, 2022.
The ViziShot 2FLEX needle may have undetected deformed tips that could cause injury during tissue biopsy procedures.
Check for model number NA-U403SX-4019 and production dates after July 29, 2022.
The recall does not specify a remedy, so contact Olympus directly for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-2484-2025 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-2484-2025 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
