Olympus recalls NA-401D-1321 aspiration needles due to inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected units include specific model numbers sold in certain regions.
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. This could let infections enter the body if the needle isn't properly sterile.
The needle's packaging may not seal properly, allowing contaminants to enter the sterile package. If the needle is used without being sterile, it could cause infections during medical procedures.
Healthcare professionals using the needle for endoscopic procedures in respiratory organs are most at risk. Patients receiving the procedure with this needle could be affected if the seal fails.
Check for model number NA-401D-1321 on the needle packaging. The product was sold in specific regions with codes like 01K through 9ZK.
Inspect the needle packaging for signs of a partial heat seal that might compromise sterility.
The recall states that a small percentage of packages have inadequate seals, so it's not safe to use without checking the seal.
Look for model number NA-401D-1321 on the packaging, and check the region codes like 01K through 9ZK.
The recall doesn't specify a remedy, so check the package seal for proper sterility before use.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1054-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1054-2021 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.
