Olympus recalls GF-UE160-AL5 ultrasound endoscopes due to updated cleaning instructions potentially increasing infection risk during patient procedures.
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-UE160-AL5 ultrasound endoscopes because a recent update to their cleaning instructions may increase the risk of patient infections. This is a safety issue for medical professionals using the device.
The device's cleaning instructions were updated to reduce infection risks, but the change could potentially lead to patient infections if not followed correctly. This is a procedural risk rather than a physical hazard.
Medical professionals who use Olympus GF-UE160-AL5 ultrasound endoscopes for gastrointestinal imaging are most at risk. Patients using these devices may also be affected if proper infection control isn't maintained.
Check for the model number GF-UE160-AL5 on the device. This endoscope is used for imaging the gastrointestinal wall, bile ducts, and pancreatic ducts.
Check the device's current Instructions For Use for updated cleaning procedures to ensure proper infection control.
The recall is about updated cleaning instructions to reduce infection risk, not an immediate safety hazard. Proper use with current instructions should be safe.
No, but you should review the updated cleaning instructions to ensure patient safety.
Check the device's Instructions For Use for the latest cleaning procedures to minimize 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-0507-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0507-2021 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.
