Olympus Ultrasound Endoscope Recall for Infection Risk Reduction
Olympus is recalling ultrasound endoscopes to update cleaning instructions and reduce the risk of patient infections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall addresses a risk of patient infection (a high-risk hazard) without reported illnesses, fitting the criteria for a High severity score.
Plain-English summary
Olympus Corporation of the Americas is recalling Olympus Ultrasound Endoscopes, including Model GF-UE160-AL5 and other listed models. The recall involves a total of 2,691 units of the specific model mentioned in the product name, with a wider distribution of over 8,000 devices across various models in the United States.
The recall was initiated because a new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU). This update is intended to reduce the risk of causing patient infections. The source text does not report any specific illnesses or injuries associated with this recall.
The devices are distributed worldwide and nationwide in the US. Consumers and healthcare facilities should refer to the updated Instructions For Use to ensure proper cleaning and disinfection procedures are followed to mitigate infection risks.
The recalled product
- Product
- Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 2,691
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Serial/Lot Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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