Olympus recalls NEEDLEMASTER 5MMx 25G Lower (model NM-610U-0525) due to potential inadequate package seals that could cause infections. Affected units sold in specific batches.
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 endoscopic needle used in medical procedures because some packages may have poor seals. This could lead to infections if non-sterile equipment is used during surgery.
The sterile packages may have inadequate seals due to partial heat sealing. If the seal is compromised, the equipment could become non-sterile, increasing infection risk during medical procedures.
Medical professionals using the NEEDLEMASTER 5MMx 25G Lower for endoscopic procedures in the GI tract. Patients at risk if non-sterile equipment is used during surgery.
Check for model number NM-610U-0525 on the product. The product was sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Inspect the package for signs of inadequate sealing, such as gaps or tears.
The recall indicates a small percentage of packages may have inadequate seals, so it's not guaranteed safe. Always check the seal before use.
Look for model number NM-610U-0525 and batch codes from 01K through 9ZK or 05V through 09V.
The recall does not specify a remedy, so check the package seal before use. 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-1046-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1046-2021 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.
