Olympus recalls GF-UM130 ultrasound endoscopes due to potential infection risks from improper cleaning steps in the device's instructions. All units sold are affected.
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Olympus is recalling all GF-UM13:0 ultrasound endoscopes used with their endoscopic ultrasound systems because a recent update to cleaning instructions may increase infection risks during patient procedures. This recall affects healthcare providers and facilities using the device for medical imaging.
The device's instructions for cleaning and disinfection were updated to reduce infection risks, but improper following of these steps could lead to patient infections. This is a procedural risk rather than a physical hazard.
Healthcare providers and medical facilities that use Olympus Ultrasound Endoscopes (model GF-UM130) for endoscopic ultrasound imaging are affected. The risk is highest for professionals handling the device daily.
Check for the model number GF-UM130 on the endoscope. All units sold by Olympus Corporation of the Americas are affected, regardless of serial or lot numbers.
Check the device's Instructions For Use (IFU) for updated cleaning steps to ensure proper disinfection.
No, only the specific model GF-UM130 used with Olympus Endoscopic Ultrasound systems is affected.
Look for the model number GF-UM130 on the endoscope. All units sold by Olympus Corporation of the Americas are affected.
Review the updated cleaning instructions in the device's Instructions For Use (IFU) to ensure proper disinfection.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0502-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0502-2021 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.
