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

Recall Z-1911-2025 — Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

U.S. FDA — Device Enforcement · United States · 2025-05-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1911-2025
Date of alert
2025-05-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Olympus Corporation of the Americas
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04953170405563
Reported risk: Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.