Olympus recalls NEEDLEMASTER 1.8MMx26G Lower (model NM-610U-1826) due to inadequate sterile packaging 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 certain NEEDLEMASTER 1.8MMx26G Lower surgical needles because some packages have poor seals that might let bacteria in. Using these could lead to infections during medical procedures.
The sterile packaging may not seal properly, allowing bacteria to enter the needle. If the needle is used without a proper seal, it could cause infections during medical procedures.
Healthcare professionals using these needles for endoscopic procedures in the GI tract. Patients receiving procedures with the recalled needles are at risk of infection.
Check for model number NM-610U-1826. The product was sold in specific batches labeled 01K through 9ZK and 05V through 09V.
Inspect the packaging for signs of a partial heat seal that might allow bacteria entry.
The recall is for a small percentage of packages with inadequate seals. If you can't see a seal issue, you may use them safely, but Olympus recommends checking the seal.
The model number is NM-610U-1826. Look for batch labels from 01K through 9ZK and 05V through 09V on the packaging.
Olympus does not provide a specific remedy in this recall notice. Check the packaging seal for issues and 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-1049-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1049-2021 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.
