Olympus recalls NEEDLEMASTER 4MMx 25G Lower (model NM-610U-0425) due to potential inadequate sterile package seals, which could lead to infections if non-sterile equipment is used. 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 endoscopic needle model because some sterile packages have weak seals that might not be sterile. Using these could cause infections in patients during medical procedures.
The sterile packaging may have partial heat seals, meaning the equipment could become contaminated. If non-sterile needles are used during endoscopic procedures, patients might develop infections.
Healthcare professionals using the NEEDLEMASTER 4MMx 25G Lower with endoscopes for GI procedures. Patients at risk if non-sterile equipment is used during surgery.
Check for model number NM-610U-0425. Affected units were sold in batches labeled 01K through 9ZK and 05V through 09V.
Inspect the sterile packaging for partial heat seals that may compromise sterility.
The recall indicates a small percentage of packages have inadequate seals, so it's not safe to use without checking the seal.
The official notice does not specify a remedy, so check the package seal for partial heat seals before use.
Look for model number NM-610U-0425 and batch labels from 01K through 9ZK or 05V through 09V.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1043-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1043-2021 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.
