Olympus recalls SD-400 single-use 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 (SD-400U-10) because small holes in the packaging during shipping or handling could compromise sterility. This risk means the devices might not be sterile when used, potentially causing infections during medical procedures.
Small holes may form in the packaging during shipping or handling, which could allow contaminants to enter the sterile device pouch. This compromises sterility, meaning the device might not be sterile when used during medical procedures.
Medical professionals using Olympus Single Use Electrosurgical Snare SD-400 devices for gastrointestinal procedures are affected. Patients undergoing these procedures with compromised sterility could face infection risks.
Check for the model number SD-400U-10 on the device. Affected units include specific lot numbers: 27V, 28V, 29V, 2XV, 2YV, 2ZV, 31V, 32V, 33V, 34V, 35V, 36V, 37V, 38V, 39V, 3XV, 3YV, 3ZV, 41V, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 51V, 52V, 53V, 54V, 55V, 56V, 57V.
Look for the lot number on the device packaging to determine if it is affected. Affected lot numbers are listed in the recall notice.
The recall is due to potential sterility compromise from small holes that may occur during packaging or transportation, which could allow contaminants to enter the device pouch.
The recall notice does not specify a remedy, so affected users should check the lot number and contact Olympus for further instructions.
Check the lot number on the device packaging. Affected units include specific lot numbers: 27V, 28V, 29V, 2XV, 2YV, 2ZV, 31V, 32V, 33V, 34V, 35V, 36V, 37V, 38V, 39V, 3XV, 3YV, 3ZV, 41V, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 51V, 52V, 53V, 54V, 55V, 56V, 57V.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0482-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0482-2026 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.
