Air/Water Valve Used with Olympus Endoscopes May Malfunction
Olympus air/water valves used with ultrasonic endoscopes may fail during automated reprocessing, potentially allowing body fluids to backflow into the air channel. Approximately 29,590 units nationwide are affected.
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: FDA Class II device with potential for body fluid contamination during endoscopy procedures. This qualifies as a risk-of-harm medical device where no illnesses or injuries have been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling the air/water valve (model MAJ-1444) used with several ultrasonic endoscope models, including gastrofiberscopes, gastrovideoscopes, and colonovideoscopes. Approximately 29,590 units have been distributed nationwide.
The valve may become damaged during repeated automated reprocessing in Olympus OER-Pro and OER-Elite reprocessing machines. When damaged, the valve can lose its one-way valve functionality, potentially allowing body fluids to backflow into the air/water channel during endoscopy procedures. This could expose patients to contamination during medical procedures.
The recalled product
- Product
- The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 29,590
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)
- UDI-DI: 04953170355929. All lot numbers
Distribution
Distributed nationwide across the United States.
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