Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1010-2019 — Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

U.S. FDA — Device Enforcement · United States · 2018-12-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1010-2019
Date of alert
2018-12-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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