United StatesThe Olympus Single Use Distal Cover (Catalog Number MAJ-2315; UDI/DI 04953170441271; Lot numbers H2530 or later), used with the EVIS EXERA III Duodenovideoscope TJF-Q190V, is being recalled nationwide in the United States (988,700 units distributed). Olympus has developed and released a newly designed version of the Distal Cover to replace the previous design, and initiated this recall to replace the earlier Single Use Distal Covers.
What's being recalled
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
UDI/DI: 04953170441271, Lot Numbers: H2530 or later
The hazard
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
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)