Olympus recalls NEEDLEMASTER 4MMx23G Lower (model NM-610U-0423) due to potential inadequate package seals that could cause 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 in medical procedures because some packages may have poor seals. This could lead to infections if the equipment is not sterile. Patients using these needles should check their model number and contact Olympus if they have the recalled item.
The sterile packages may have partial heat seals, meaning the equipment could become non-sterile. If non-sterile needles are used during procedures, patients might develop infections. This is a small percentage of units but requires careful handling.
Medical professionals using the NEEDLEMASTER 4MMx23G Lower with endoscopes for GI procedures. Patients who have received this specific needle during procedures are at risk if the seal was inadequate.
Check for model number NM-610U-0423 on the product. Affected units were sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Look for model number NM-610U-0423 on the needle packaging or label.
The recall indicates a small percentage of units may have inadequate seals, so it's not guaranteed to be safe. Affected users should check their model and contact Olympus.
Check for model number NM-610U-0423 and batch codes from 01K through 9ZK or 05V through 09V.
The recall does not require immediate stop use; affected users should check their model and contact Olympus for guidance.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1042-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1042-2021 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.
