Olympus recalls ViziShot 2 21G aspiration needles due to slight resistance during needle advancement. Affected units have specific model and lot numbers. Consumers should contact Olympus for details.
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Olympus is recalling ViziShot 2 Single Use Aspiration Needles that may cause slight resistance during use. This could lead to minor discomfort or difficulty when performing ultrasound-guided procedures. The recall affects specific model and lot numbers.
The needle angle does not meet manufacturing specifications and remains unbent, causing slight resistance when advancing or retracting the needle. This may lead to minor discomfort or difficulty during procedures but does not pose a serious injury risk.
Medical professionals using ultrasound endoscopes for fine needle aspiration procedures. Patients undergoing these procedures with the recalled needles are at low risk of injury.
Check for model numbers NA-U401SX-4021 or NA-U401SX-4021-A and lot numbers listed in the recall notice. The product is used with ultrasound endoscopes for fine needle aspiration procedures.
Reach out to Olympus Corporation of the Americas for specific instructions on how to handle the recalled product.
The needles may cause slight resistance during advancement and retraction due to an angle that does not meet manufacturing specifications.
Affected models are NA-U401SX-4021 and NA-U401SX-4021-A with specific lot numbers listed in the recall notice.
No, the recall indicates a low risk of minor discomfort but does not require immediate discontinuation.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1615-2023 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1615-2023 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.
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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.
