Olympus recalls GF-UCT140P-AL5 ultrasound endoscopes due to updated cleaning instructions that may increase infection risk during use. All units 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.
Olymp: Olympus is recalling ultrasound endoscopes (model GF-UCT140P-AL5) because their cleaning instructions could lead to patient infections if not followed correctly. This affects all units sold for gastrointestinal procedures.
The device requires specific cleaning steps to prevent infections. If the cleaning instructions are not followed correctly, it could lead to patient infections during medical procedures.
Healthcare professionals using these endoscopes for gastrointestinal procedures are affected. Patients undergoing procedures with this equipment face the lowest risk of infection.
Check for the model number GF-UCT140P-AL5 on the device. All units sold for endoscopic ultrasound imaging and surgery in the gastrointestinal tract are affected.
Check the device's Instructions For Use for the updated cleaning steps to ensure proper infection control.
Yes, but only if cleaned according to the updated Instructions For Use to reduce infection risk.
Look for the model number GF-UCT140P-AL5 on the device. All units used for gastrointestinal procedures are affected.
No, but you must follow the updated cleaning instructions to prevent infection risks.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0498-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0498-2021 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.
