Olympus recalls NEEDLEMASTER 3MMx 23G LOWER (model NM-610L-0523) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units sold in specific years and regions.
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 inadequate seals, which could cause infections if the equipment is used without proper sterility. This affects medical professionals using the product for GI procedures.
The sterile packages may have partial heat seals, meaning the equipment might not be sterile when opened. If non-sterile equipment is used during procedures, patients could get infections.
Medical professionals who use the NEEDLEMASTER 3MMx 23G LOWER endoscopic needle during GI procedures are most at risk. Patients could develop infections if non-sterile equipment is used.
Check for the model number NM-610L-0523 on the product label. The product was sold in specific years: 01K, 98K, 99K, 9YX, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV.
Inspect the sterile package for adequate heat sealing; if the seal appears damaged or incomplete, do not use the product.
The product may have inadequate package seals, so it is not guaranteed to be sterile. Always check the seal before use.
Check the package seal; if it appears damaged, do not use it. Olympus does not provide a replacement or refund for this specific recall.
The product was sold in specific years: 01K, 98K, 99K, 9YX, 9ZK, 05V, 06V, 07V, 08V, 09V, 0XV. The exact regions are not specified in the recall notice.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1035-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1035-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
