Olympus recalls NEEDLEMASTER 4MMx26G Lower (model NM-610U-0426) due to inadequate package seals that 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 type of endoscopic needle used for GI procedures because some packages have poor seals that might let bacteria in. Using these needles could cause infections in patients.
The sterile packages sometimes have partial heat seals, meaning they might not stay sealed properly. If the seal breaks, bacteria could enter the equipment, leading to infections during medical procedures.
Healthcare professionals using the NEEDLEMASTER 4MMx26G Lower with endoscopes for GI procedures. Patients receiving procedures with these needles are at risk of infection if the seal fails.
Check for model number NM-610U-0426. The product was sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Inspect the package for signs of partial heat sealing, which may indicate a compromised seal.
The recall states patients may develop infections if non-sterile equipment is used, but it does not mention serious injury risks.
Look for model number NM-610U-0426 and batch codes from 01K through 9ZK or 05V through 09V.
The recall does not specify a remedy, so users should check the package seal and contact Olympus if concerned.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1044-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1044-2021 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.
