Olympus recalls NEEDLEMASTER 4MMx23G Upper (model NM-610L-0423) due to inadequate sterile package seals that could lead to infections if non-sterile equipment is used. Affected units were 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 certain NEEDLEMASTER 4MMx23G Upper endoscopic needles because some sterile packages have poor seals. This could lead to infections if the needles are used without proper sterility. Patients using these needles should stop using them immediately.
The sterile packages for these needles sometimes have partial heat seals, meaning they aren't fully sealed. If the package isn't sealed properly, the needles could become contaminated, leading to infections for patients during medical procedures.
Healthcare professionals using the NEEDLEMASTER 4MMx23G Upper with endoscopes for GI procedures are most at risk. Patients receiving these procedures may be affected if the needles are not properly sterilized.
Check for the model number NM-610L-0423 on the needle package. Affected units were sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Inspect the sterile package for partial heat seals that may indicate inadequate sealing.
If the package shows signs of poor sealing, do not use the needle and contact Olympus for a replacement.
Inspection confirmed a small percentage of sterile packages have inadequate seals, which could lead to infections if non-sterile equipment is used.
Look for the model number NM-610L-0423 on the package and check the batch codes (01K through 9ZK and 05V through 09V).
Inspect the package seal; if it appears unsealed, stop using it and contact Olympus for a replacement.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1031-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1031-2021 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.
