Olympus recalls GF-UM20 ultrasound endoscopes due to updated cleaning instructions that may increase infection risk during patient procedures. Affected units require review of cleaning steps to prevent patient infections.
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.
Olymp: Olympus is recalling its GF-UM20 ultrasound endoscopes because a recent update to their cleaning instructions could lead to patient infections if not followed correctly. This recall is important because improper cleaning steps might cause infections during medical procedures.
The device requires specific cleaning steps to prevent infections. If the updated cleaning instructions are not followed correctly, there is a risk of patient infections during medical procedures.
Medical professionals using Olympus GF-UM20 ultrasound endoscopes for gastrointestinal procedures are most at risk. Patients undergoing these procedures may also be affected if the device is not cleaned properly.
Check for the model number GF-UM20 on the device. The product is used for endoscopic real-time ultrasound imaging and surgery within the gastrointestinal tract. All units were sold with the same serial/lot numbers.
Check the updated cleaning and disinfection steps in the Instructions For Use (IFU) for the device to ensure proper infection prevention.
The recall is for medical professionals using the device. Patients are affected only if the device is not cleaned properly during procedures.
Look for the model number GF-UM20 on the device. The product is used for endoscopic real-time ultrasound imaging and surgery within the gastrointestinal tract.
The recall does not require returning the device. Medical professionals should follow the updated cleaning instructions to prevent infections.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0501-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0501-2021 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.
