Olympus Ultrasound Endoscope Recall for Infection Risk Mitigation
Olympus is recalling ultrasound endoscopes to reduce the risk of patient infections by adding a new inspection step to the cleaning and disinfection instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, which is a high-risk hazard, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Olympus Corporation of the Americas is recalling specific models of the Olympus Ultrasound Endoscope, including the GF-UCT160-OL5. The recall involves 49 units of the GF-UCT160-OL5 model, along with other related models distributed in the United States and worldwide.
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.
Healthcare facilities and users of these devices should review the updated Instructions For Use to ensure proper cleaning and disinfection protocols are followed to mitigate infection risks.
The recalled product
- Product
- Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 49
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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