The Recall Desk
HighFDA (Devices)·Z-2447-2023·Announced 2023-08-30

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.

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: 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, GF-UCT160-OL
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscope / Reprocessing
Hazard
  • valve-malfunction
  • contamination

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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