FDA-Device2019-03-20Class II
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Hazard
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
Sold states
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Affected count
1
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2019More Olympus Corporation of the Americas recalls
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- FDA-Device2026-07-22Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
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