Olympus recalls specific endoscopic injectors due to potential inadequate sterile packaging, which could lead to infections if non-sterile equipment is used. Affected models include NM-400U-0525 with certain serial numbers.
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 injector model because some sterile packages have poor seals, increasing infection risk during medical procedures. Patients using these injectors could face infections if the equipment isn't properly sterile.
The sterile packaging for some units has a partial heat seal, meaning the equipment might not be properly sterile. If non-sterile equipment is used during medical procedures, patients could develop infections.
Healthcare professionals using the recalled injector model for endoscopic procedures are most at risk. Patients receiving treatments with this device may face infection if the equipment isn't sterile.
Check for the model number NM-400U-0525 with serial numbers starting with 01K, 02K, 03K, 05K, 06K, 09K, 0XK, 98K, 99K, 9YK, 05V, 06V, 07V, 08V, 09V, or 0XV. These injectors are used for endoscopic treatments of esophageal and gastric varices.
Inspect the sterile packaging for a partial heat seal, which may indicate inadequate sterility.
The recall indicates a small percentage of units have inadequate seals, so not all units are unsafe. Only those with partial heat seals should be checked.
Look for the model number NM-400U-0525 with serial numbers starting with 01K, 02K, 03K, 05K, 06K, 09K, 0XK, 98K, 99K, 9YK, 05V, 06V, 07V, 08V, 09V, or 0XV.
The recall does not specify a remedy, so contact Olympus directly for guidance on handling the product.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-1021-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-1021-2021 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.
