Olympus recalls specific NEEDLEMASTER 4MMx 26G UPPER models due to inadequate sterile packaging seals, which could lead to infections if non-sterile equipment is used. Affected units were sold in certain regions and models.
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. This could lead to infections if the equipment is not sterile. Patients using these needles should contact Olympus for guidance.
The sterile packaging may have partial heat seals, meaning the equipment could become non-sterile. If non-sterile equipment is used during medical procedures, patients may develop infections.
Healthcare professionals using the NEEDLEMASTER 4MMx 26G UPPER for endoscopic procedures in the GI tract. Patients receiving these procedures are at risk if the equipment is not properly sterile.
Check for model number NM-610L-0426 on the packaging. The product was sold in certain regions with specific model codes like 01K through 9ZK and 05V through 0XV.
Inspect the packaging for partial heat seals that may compromise sterility.
The recall indicates a small percentage of packages have inadequate seals, so it may not be sterile. Contact Olympus for specific guidance.
Look for model number NM-610L-0426 on the packaging. The product was sold with specific model codes like 01K through 9ZK and 05V through 0XV.
The recall does not specify a remedy, so contact Olympus directly for instructions.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1033-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1033-2021 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.