Olympus recalls certain Vizishot 22G aspiration needles used with ultrasound. A small percentage have inadequate package seals, potentially causing infections if non-sterile equipment is used.
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 specific models of Vizishot 22G aspiration needles used with ultrasound. These needles may have poor seals that could lead to infections if used improperly.
The needles have a small percentage with inadequate package seals. If the seal is compromised, the equipment may not be sterile, increasing the risk of infection during medical procedures.
Healthcare professionals using ultrasound-guided fine needle aspiration procedures with these specific needle models are most at risk. Patients using non-sterile equipment could develop infections.
Check for model numbers NA-201SX-4022-A or NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G. These needles were sold with ultrasound endoscopes for procedures like lung or esophageal biopsies.
Inspect the packaging for a partial heat seal; if the seal is broken, the needle may not be sterile.
A small percentage of these needles have inadequate package seals, which could lead to infections if non-sterile equipment is used.
Look for model numbers NA-201SX-4022-A or NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G on the packaging.
The recall does not provide a remedy; users should check the seal and avoid using needles with compromised packaging.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1060-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1060-2021 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.
