Olympus recalls NEEDLEMASTER 3MMx 26G LOWER (model NM-610U-0326) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units sold in specific regions and years.
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 during medical procedures.
The sterile packaging may have partial heat seals, meaning the seal could be broken during handling or storage. If the packaging is compromised, the needle might not be sterile, increasing infection risk during medical procedures.
Medical professionals using the NEEDLEMASTER 3MMx 26G LOWER needle for endoscopic procedures in the GI tract. Patients at risk if non-sterile equipment is used during surgery.
Check for the model number NM-610U-0326 on the product. The needles were sold in specific regions (01K, 02K, 04K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV) between 2000 and 2009.
Inspect the packaging for partial heat seals that may compromise sterility.
The recall indicates a small percentage of packages have inadequate seals, so it's not safe to use without checking the seal.
Look for the model number NM-610U-0326 and check the specific region codes (01K, 02K, 04K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV) on the packaging.
The recall does not specify a remedy, so check the package seal and contact Olympus for further guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1041-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1041-2021 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.
