Olympus recalls NEEDLEMASTER 3MMx23G Lower (model NM-610U-0323) due to potential inadequate package seals that could cause infections. 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 have poor seals that might lead to infections. Patients using non-sterile equipment could face infection risks.
The sterile packages may have partial heat seals, meaning they aren't properly sealed. If the package isn't sealed correctly, the equipment could become non-sterile, increasing infection risk during medical procedures.
Medical professionals using the NEEDLEMASTER 3MMx23G Lower with endoscopes for GI procedures. Patients receiving procedures with this device are at risk if the seal is inadequate.
Check for model number NM-610U-0323. The product was sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Inspect the package for signs of partial heat sealing, which could indicate inadequate sterility.
The recall indicates a small percentage of packages have inadequate seals, so it's not guaranteed to be safe. Always check for proper sealing before use.
Look for model number NM-610U-0323 in the product's batch labels, which include codes like 01K through 9ZK and 05V through 09V.
The recall doesn't specify a remedy, so check the package seal for proper sterility before use. Contact Olympus if you have concerns.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1040-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1040-2021 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.
