Olympus recalls certain Vizishot 21G aspiration needles due to potential inadequate packaging seals, which could lead to infections if non-sterile equipment is used. Affected models include NA-201SX-4021 with specific serial numbers.
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Olympus is recalling certain Vizishot 21G aspiration needles that may have poor packaging seals. This could lead to infections if the needles are used without proper sterility.
The needles may have inadequate packaging seals, meaning the sterile packaging could be compromised. If non-sterile equipment is used, patients might develop infections during procedures.
Healthcare professionals using ultrasound endoscopes for needle procedures are most at risk. Patients undergoing these procedures with the recalled needles could face infection.
Check for the model number NA-201SX-4021 on the packaging. The product was sold with specific serial numbers including 01K through 9ZK and 95V through 9ZV.
Inspect the packaging for any signs of poor sealing, such as leaks or damage.
The recall is due to a small percentage of sterile packages having inadequate seals, which could lead to infections if non-sterile equipment is used.
The affected model is NA-201SX-4021 with specific serial numbers including 01K through 9ZK and 95V through 9ZV.
Look for the model number NA-201SX-4021 on the packaging and check the serial numbers listed in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1059-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1059-2021 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.
