Olympus recalls NEEDLEMASTER 4MMx 25G UPPER (model NM-610L-0425) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units were sold with specific model codes.
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 in medical procedures because some packages may have inadequate seals. This could lead to infections if the equipment is not sterile. Patients using this product should contact Olympus for details.
The sterile packages may have partial heat seals, meaning the seal isn't fully closed. If the seal is compromised, the equipment could become non-sterile, increasing the risk of infections during medical procedures.
Healthcare professionals using the NEEDLEMASTER 4MMx 25G UPPER for endoscopic procedures. Patients receiving these procedures are at risk if the equipment is not sterile.
Check for the model number NM-610L-0425 on the product. Affected units were sold with specific model codes: 02K, 03K, 05K, 07K, 08K, 0XK, 98K, 99K, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Look for the model number NM-610L-0425 on the product to confirm if it is affected.
The recall indicates a small percentage of packages may have inadequate seals, so it could lead to infections if non-sterile. Affected units should be checked and handled according to the recall instructions.
Check for the model number NM-610L-0425 and the specific model codes listed in the recall: 02K, 03K, 05K, 07K, 08K, 0XK, 98K, 99K, 9YK, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
The recall does not specify a remedy, so contact Olympus directly for guidance on whether to stop using or return 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-1032-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1032-2021 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.
