Olympus recalls NEEDLEMASTER 6MMx 25G LOWER (model NM-610U-0625) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units were sold in specific regions and models.
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 could allow contamination. Using these needles without proper sterility could lead to infections in patients.
The sterile packages may have partial heat seals, meaning they aren't fully sealed. If the package isn't properly sealed, the equipment could become contaminated, increasing the risk of infection for patients during medical procedures.
Healthcare professionals using the NEEDLEMASTER 6MMx 25G LOWER model for endoscopic procedures in the GI tract. Patients at risk if non-sterile equipment is used during procedures.
Check for the model number NM-610U-0625 on the product. The needles are used with endoscopes for GI procedures and were sold in specific regions and model codes listed in the recall notice.
Inspect the sterile package for signs of partial heat sealing, which may indicate inadequate sterility.
The recall indicates a small percentage of packages have inadequate seals, so it's not safe to assume all units are sterile. Use only units confirmed to be sealed properly.
Look for the model number NM-610U-0625 on the product, which is used for endoscopic procedures in the GI tract.
The recall does not specify a remedy, so contact Olympus directly for guidance on handling the product.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1048-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1048-2021 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.
