Olympus recalls NA-411D-1321 aspiration needles due to inadequate sterile packaging seals that could lead to infections. Affected units were 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 might let bacteria in. This could cause infections if the needle isn't properly sterile.
The needle packages sometimes have partial heat seals, meaning the sterile packaging isn't fully closed. If the seal breaks, bacteria could enter the needle, leading to infections during medical procedures.
Healthcare professionals using endoscopes for respiratory tissue sampling are most at risk. Patients using these needles could get infections if the seal fails.
Check for the model number NA-411D-1321 on the needle packaging. These needles were sold with specific model codes like 01K through 9ZK.
Inspect the needle packaging for a partial heat seal that might be visible as a gap or uneven line.
The recall is because a small percentage of sterile packages have inadequate seals, which could allow bacteria to enter the needle and cause infections.
Look for the model number NA-411D-1321 on the packaging. These needles were sold with model codes 01K through 9ZK.
Inspect the packaging for a partial heat seal. If you find a seal issue, contact Olympus for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1056-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1056-2021 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.
