Olympus recalls some ViziShot 22G aspiration needles due to inadequate sterile packaging seals, which may lead to infections if non-sterile equipment is used. Affected models include NA-201SX-4022-B 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 22G aspiration needles that may have poor sterile packaging seals. If these needles are used without proper sterility, patients could develop infections.
The needles may have inadequate sterile packaging seals, meaning the equipment could become non-sterile. If non-sterile needles are used during medical procedures, patients might develop infections.
Healthcare professionals using ultrasound-guided fine needle aspiration procedures with these specific models are most at risk. Patients using the needles for medical procedures may be affected if the needles are not sterile.
Check for the model number NA-201SX-4022-B on the packaging. Affected units were sold with serial numbers starting with 07K, 08K, 92K, 93K, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the packaging for signs of inadequate sealing, such as leaks or damage.
Inspection confirmed a small percentage of sterile packages had inadequate seals, which could lead to infections if non-sterile equipment is used.
The model number NA-201SX-4022-B with specific serial numbers starting with 07K, 08K, 92K, 93K, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV.
No specific stop-use instruction is provided; the recall focuses on potential infection risk from poor seals, not 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-1061-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1061-2021 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.
