ProductGuru Recalls

Official recall record

Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V

US FDA — Medical Devices · 2025-05-05 · United StatesClass II
Issuing authority
US FDA — Medical Devices
Recall initiated by firm
2025-05-05
Country of alert
United States
Alert level
Class II
Alert type
recall
Barcode (EAN/GTIN)
04953170405563
Brand on record
Olympus Corporation of the Americas

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

Other recalls from this brand

All 8 official recall notices naming Olympus Corporation of the Americas on this site →

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.