United StatesThe affected product is the Olympus EVIS EXERA III duodenovideoscope, model/catalog number TJF-Q190V (UDI: 04953170405563 / 04953170452024; serial numbers: all). The device was recalled after continued reports of positive cultures and infections led Olympus to update reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing; Olympus is informing users, reminding them to closely follow the operation and reprocessing instructions, and providing updated materials.
What's being recalled
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model/Catalog Number: TJF-Q190V; UDI: 04953170405563 / 04953170452024; Serial Numbers: All;
The hazard
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)