Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
FDA Recall Z-1010-2019 · Posted None
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Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeNWB
Date Initiated2018-12-17
Date Terminated2020-11-18
Product Quantity2
Reason for Recall
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.
Firm Action
Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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