Olympus recalls NEEDLEMASTER 6MMx 23G Lower (model NM-610U-0623) due to inadequate package seals that may cause infections if non-sterile equipment is used. Affected units sold in specific kits.
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 poor seals. This could lead to infections if the equipment isn't properly sterile. Affected units are identified by model number and kit types.
The sterile packages may have partial heat seals, meaning they aren't fully sealed. If the package isn't properly sealed, the equipment could become non-sterile, increasing infection risk during medical procedures.
Healthcare professionals using the NEEDLEMASTER 6MMx 23G Lower with endoscopes for GI procedures. Patients at risk if non-sterile equipment is used during procedures.
Check for model number NM-610U-0623 on the product. Affected units were sold in kits labeled 01K through 9ZK and 05V through 09V.
Inspect the package for partial heat seals that may allow contamination.
The recall indicates a small percentage of packages have inadequate seals, so it's not guaranteed safe. Always check for partial heat seals.
The recall doesn't specify a remedy, so contact Olympus directly for guidance.
Kits labeled 01K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 06V, 07V, 09V, 0XV.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1047-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1047-2021 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.
