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Lower risk Medical device recall · FDA · Published September 4, 2024

Olympus Electrosurgical Generator Model ESG-410 (SEP) Version WA91327U: Audio Buffer Error

Olympus recalls ESG-410 (SEP) Version WA91327U due to system error E1226 "Could not write to Audio Buffer" during surgical procedures. Affected units have specific serial numbers and UDI-DI codes.

🇺🇸 FDA recall #Z-0264-2025Medical deviceOlympus ›
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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer

What happened, in plain English

Olympus is recalling certain Electrosurgical Generators (ESG-410 SEP) with version WA91327U because they may cause audio buffer errors during surgical procedures. This could lead to communication issues between the device and surgical equipment, potentially affecting patient safety. Read more at govinfonow.com/recall/54071-olympus-electrosurgical-generator-model-esg-410-sep-version-wa91327u-audio.

Source Summary by GovInfoNow · govinfonow.com/recall/54071-olympus-electrosurgical-generator-model-esg-410-sep-version-wa91327u-audio · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0264-2025

Cite this page

“Olympus Electrosurgical Generator Model ESG-410 (SEP) Version WA91327U: Audio Buffer Error.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54071-olympus-electrosurgical-generator-model-esg-410-sep-version-wa91327u-audio. Based on FDA recall #Z-0264-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0264-2025%22&limit=1).

Why it’s dangerous

The device may experience system error E1226, which prevents it from writing to the audio buffer during procedures. This could cause communication issues between the surgical team and the device, potentially affecting patient safety during surgery.

Who’s affected

Medical professionals using the Olympus ESG-410 (SEP) version WA91327U for surgical procedures are most likely affected. Patients using this device during surgery may be at risk if audio communication fails.

How to tell if you have this one

Check for the model number ESG-410 (SEP) with version WA91327U. Affected units have specific serial numbers listed in the recall notice and a UDI-DI code of 04042761087698.

  • Brand
    Olympus
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Version

    Verify your device's version code is WA91327U by checking the label on the device.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Sep 4, 202412. FDA classified it Class II: Oct 30, 202423. Published in FDA’s Enforcement Report: Nov 6, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this device dangerous?

The recall indicates a potential audio buffer error during procedures, but the device is not considered dangerous under normal use. Olympus has not specified a risk of injury.

What should I do if I have this device?

Olympus has not provided a remedy for this recall. Affected users should check their device version and contact Olympus if they have concerns.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0264-2025 (September 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0264-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA