Olympus recalls some ViziShot 22G aspiration needles due to inadequate package seals that could lead to infections if non-sterile equipment is used. Affected models were sold 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 because some packages have poor seals that might allow contamination. Using these needles could lead to infections in patients.
The needles' sterile packages may have partial heat seals, meaning they could become non-sterile. If non-sterile equipment is used during procedures, patients might get infections.
Healthcare professionals using ultrasound endoscopes for needle procedures are most at risk. Patients receiving these needles could develop infections if the equipment isn't sterile.
Check for model number NA-201SX-4022-C. These needles were sold with specific serial numbers: 03K, 04K, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the needle package for a partial heat seal that might indicate non-sterility.
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.
Model number NA-201SX-4022-C with serial numbers 03K, 04K, 95V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV.
Check for the model number NA-201SX-4022-C and the specific serial numbers listed in the recall.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1062-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1062-2021 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.
