Olympus recalls NA-601D-1519 aspiration needles due to inadequate sterile packaging seals, which may lead to infections if non-sterile equipment is used. 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 could allow infections. This is a serious risk for patients during medical procedures.
The needle packaging may have a partial heat seal, meaning the sterile packaging isn't fully intact. If the needle is used without proper sterility, patients could develop infections during medical procedures.
Patients undergoing endoscopic procedures using this needle model are most at risk. Healthcare providers who use the product may also be affected if they have the recalled item.
Check for the model number NA-601D-1519 on the needle packaging. The product was sold in specific model ranges including 01K through 9ZK.
Look for the model number NA-601D-1519 on the packaging to confirm if it's affected.
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.
The affected model is NA-601D-1519, sold in specific ranges including 01K through 9ZK.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1058-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1058-2021 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.
