Reported Aug 30, 2023 · Ongoing
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- The Air/Water Valve is provided/used
- with the following EndoscopesULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE
- ULTRASONIC COLONOVIDEOSCOPE
GF-UC140P-AL5GF-UCT140-AL5GF-UE160-AL5GF-UCT180GF-UM20GF-UM130GF-UMQ130GF-UM160GF-UC160P-OL5GF-UCT160-OL5
- Lot codes and dates
- UDI-DI04953170355929. All lot numbers
- Amount recalled
- 29590 units
Where it was sold
- Nationwide
Why it was recalled
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
This product could cause temporary or reversible health problems — stop using it.
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