Olympus recalls NEEDLEMASTER 6MMx 25G UPPER (model NM-610L-0625) due to potential inadequate sterile packaging seals that could lead to infections if non-sterile equipment is used.
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 poor seals, which could lead to infections if the equipment isn't properly sterile. This affects medical users who perform endoscopic procedures with this product.
The sterile packages may have partial heat seals, meaning they aren't fully sealed. If the packaging isn't airtight, the equipment could become contaminated, leading to infections in patients during procedures.
Medical professionals using this endoscopic needle for procedures in the GI tract. Patients at risk if the equipment is not sterile due to the packaging issue.
Check for the model number NM-610L-0625 on the product. This needle is used with endoscopes for GI procedures and was sold in versions 05V through 09V and 0XV.
Inspect the sterile packaging for proper heat sealing; if the seal appears damaged or incomplete, do not use the product.
The recall indicates a small percentage of packages have inadequate seals, so it's not guaranteed to be safe. Always check the seal before use.
Look for the model number NM-610L-0625 on the product, which is used with endoscopes for GI procedures and was sold in versions 05V through 09V and 0XV.
Check the packaging seal; if it appears damaged, do not use it. The recall does not require immediate disposal or return as the remedy is not specified.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1039-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1039-2021 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.
