Olympus recalls NA-401D-1521 aspiration needles due to inadequate sterile packaging seals, which may lead to infections if used improperly.
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 model of aspiration needle used with endoscopes because some packages have poor seals that could cause infections. This affects patients who might use the needle without proper sterility.
The needle packaging may have a partial heat seal, meaning the sterile contents could be contaminated. If the needle is used without proper sterility, patients might develop infections.
Healthcare professionals and patients using the NA-401D-1521 aspiration needle for endoscopic procedures. Those most at risk are individuals who have used the needle without verifying the seal.
Check for the model number NA-401D-1521 on the needle packaging. The product was sold in specific batches labeled 01K through 9ZK.
Inspect the needle packaging for a partial heat seal that may indicate contamination.
The recall indicates a small percentage of packages have inadequate seals, so it's not safe to use without checking the seal first.
Look for the model number NA-401D-1521 on the packaging, which was sold in batches labeled 01K through 9ZK.
Inspect the packaging for a partial heat seal; if you find it, stop using the needle and 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-1055-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1055-2021 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.
