Olympus recalls NA-411D-1521 aspiration needles due to inadequate sterile packaging seals that could lead to infections if non-sterile equipment is used. Affected units sold in specific model ranges.
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 a specific type of aspiration needle used with endoscopes because some packages have poor seals that could allow contamination. Using these needles might lead to infections if they're not properly sterile.
The needles come in sterile packages that sometimes have partial heat seals. If the seal is broken, the needles might not be sterile, increasing infection risk during medical procedures.
Healthcare professionals who use endoscopes for respiratory tissue sampling may be affected. Patients using these needles during procedures are at risk if the seal fails.
Check for the model number NA-411D-1521 on the needle packaging. These needles were sold in specific model ranges including 01K through 9ZK.
Inspect the needle packaging for partial heat seals that may indicate inadequate 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.
Look for the model number NA-411D-1521 on the packaging, which was sold in specific model ranges including 01K through 9ZK.
The recall record does not specify a remedy, so check the package seal for partial heat seals and contact Olympus if concerned.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1057-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1057-2021 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.
