Olympus recalls SD-400 electrosurgical snare devices due to potential sterility compromise from small holes in packaging during shipping. Affected units include specific lot numbers.
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Olympus is recalling single-use electrosurgical snare devices because small holes in the packaging may compromise sterility. This could lead to infections if the device is used without proper sterilization.
Small holes can form in the packaging during shipping or handling, which may allow contaminants to enter the sterile device pouch. This compromises the device's sterility, increasing infection risk during medical procedures.
Healthcare professionals using Olympus SD-400 electrosurgical snare devices for GI procedures are most at risk. Patients undergoing procedures with these devices may face infection if sterility is compromised.
Check for lot numbers 27V through 56V on the packaging. The product model is SD-400U-15 with a unique device identifier (UDI) starting with 04953170408250.
Look for lot numbers 27V through 56V on the packaging to identify affected units.
The recall is due to potential sterility compromise from small holes in the packaging that may form during shipping or handling.
Check the lot number on the packaging. If it's between 27V and 56V, contact Olympus for instructions on how to handle the device.
The device is not safe for use if sterility is compromised, which could lead to infections during medical procedures.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0483-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0483-2026 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.
