The U.S. Food and Drug Administration issued a Class 2 device recall on Olympus single-use distal covers for duodenoscopes.
The recall was posted to an FDA database May 19, though recall notification letters sent to customers were dated April 23. It instructs customers to “immediately locate and no longer use” the original design of model MAJ-2315.
“Correct application and inspection of the distal cover before the procedure is critical,” the letter also states. “In addition, inspection of the distal end after the procedure is also important.”