Olympus recalls GF-UC160P-OL5 ultrasound endoscopes due to updated cleaning instructions that may increase 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.
Olympus is recalling ultrasound endoscopes with model number GF-UC160P-OL5 because recent changes to cleaning instructions could lead to patient infections. This affects medical professionals using the device for diagnostic imaging.
The recall involves updated cleaning instructions that may not be followed properly, potentially increasing the risk of patient infections during procedures. This is a procedural change to reduce infection risk, but improper implementation could lead to infections.
Medical professionals who use Olympus Ultrasound Endoscopes with model number GF-UC160P-OL5 for diagnostic imaging or fluid analysis are most at risk. Patients using these devices are not directly affected by the recall.
Check for the model number GF-UC160P-OL5 on the device. This ultrasound endoscope is used for diagnostic imaging or fluid flow analysis of the human body.
Check the device's Instructions For Use for updated cleaning procedures to ensure proper infection control.
The device is safe when cleaned according to the updated Instructions For Use. Improper cleaning could increase infection risk.
Look for the model number GF-UC160P-OL5 on the device, which is used for diagnostic ultrasound imaging or fluid flow analysis.
No, but you should follow the updated cleaning instructions to reduce infection risk.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0505-2021 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0505-2021 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.
