Olympus recalls NEEDLEMASTER 4MMx 21G UPPER (model NM-610L-0421) due to potential inadequate package seals that could lead to infections if non-sterile equipment is used. Affected units were sold in specific 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 endoscopic needle device because some sterile packages may have inadequate seals, increasing infection risk during medical procedures. This affects healthcare providers using the product in GI tract procedures.
The sterile packages may have partial heat seals, meaning the equipment could become non-sterile. If non-sterile equipment is used during endoscopic procedures, patients might develop infections.
Healthcare professionals using the NEEDLEMASTER 4MMx 21G UPPER for endoscopic procedures in the GI tract are most at risk. Patients using non-sterile equipment could develop infections.
Check for the model number NM-610L-0421 on the product. This device was sold in specific regions with codes 03K, 04K, 08K, 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 device.
The recall indicates a small percentage of packages may have inadequate seals, so it is not safe to use without checking the seal first.
Look for the model number NM-610L-0421 and the specific region codes 03K, 04K, 08K, 05V, 06V, 07V, 08V, 09V, 0XV on the product label.
The recall does not specify a remedy, so check the package seal before use. If the seal appears damaged, do not use the device.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1030-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1030-2021 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.
