Olympus recalls NEEDLEMASTER 5MMx 25G UPPER (model NM-610L-0525) due to inadequate sterile packaging 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 endoscopic needle device because some packages have poor seals that might let bacteria in. Using these could lead to infections during medical procedures.
The sterile packaging has partial heat seals in some units. If the seal fails, non-sterile equipment could be used during procedures, increasing infection risk.
Healthcare professionals using this device for endoscopic procedures. Patients receiving procedures with the recalled device are at risk of infection.
Check for model number NM-610L-0525. The device was sold in batches labeled 01K through 0XK, 98K through 9ZK, 05V through 09V, and 0XV.
Inspect the packaging for partial heat seals that might indicate inadequate sterility.
The recall indicates some units have inadequate seals that could lead to infections. Not all units are affected.
Look for model number NM-610L-0525 and batch codes from 01K through 0XK, 98K through 9ZK, 05V through 09V, or 0XV.
Check the package seal. If you find partial heat seals, 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-1036-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1036-2021 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.
