Olympus recalls NEEDLEMASTER 6MMx 23G UPPER (model NM-610L-0623) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units sold with endoscopes for GI procedures.
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 device because some sterile packages have weak seals that could allow contamination. Using these devices might cause infections in patients during medical procedures.
The sterile packages may have partial heat seals, meaning they aren't fully sealed. This could let bacteria enter the device, leading to infections if the equipment is used during medical procedures.
Healthcare professionals using the NEEDLEMASTER 6MMx 23G UPPER with endoscopes for GI procedures. Patients undergoing these procedures are at risk if non-sterile equipment is used.
Check for model number NM-610L-0623 on the device. The product was sold with endoscopes for GI procedures in specific series (05K, 06K, 07K, 08K, 09K, 0XK, 98K, 9XK, 05V, 06V, 07V, 08V, 09V, 0XV).
Inspect the sterile package for signs of partial heat sealing, which may cause leaks.
The recall indicates a small percentage of packages have inadequate seals that could lead to infections. Not all units are affected, but affected units should be checked.
Look for model number NM-610L-0623 on the device. The product was sold with endoscopes for GI procedures in specific series (05K, 06K, 07K, 08K, 09K, 0XK, 98K, 9XK, 05V, 06V, 07V, 08V, 09V, 0XV).
The recall does not specify a remedy, so check the package seal for partial heat sealing. If you find issues, 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-1038-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1038-2021 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.
