Olympus Ultrasound Endoscope Recall for Updated Cleaning Instructions
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 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling specific models of ultrasound endoscopes, including the GF-UM20, GF-UC140P-AL5, and others. The recall involves a total of 8,901 devices distributed in the United States, with worldwide distribution also noted.
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 agency has classified this as a Class II recall.
Healthcare facilities and users of these devices should stop using the affected endoscopes and contact Olympus Corporation of the Americas for further instructions on how to proceed with the updated cleaning protocols.
The recalled product
- Product
- Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 27
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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