Olympus (TYO:7733) is advising healthcare providers to inspect certain ultrasound endoscopes before using them due to the potential for patient infection. The global recall covers 8,522 devices distributed in the U.S., according to FDA records.
In an urgent field safety notice, the company listed 23 models of endoscopes that might contain residual blood and foreign matter in the air/water channel. These endoscopes are used in tough-to-diagnose diseases such as pancreatic cancer, according to the company. Olympus is asking medical staff to inspect each of the endoscopes before reprocessing; if they find a blockage, staff should not use the scope but contact the company for a repair.
Contaminated endoscopes have been associated with hospital- and healthcare-acquired infections, including deadly superbugs. In this latest case, Olympus reported to regulators any complaints it received about residual blood and foreign matter in the air/water channel, according to company spokesperson Jennifer Bannan. No patient injuries occurred and the FDA ruled it a Class II recall.
The recall affects 10 models in the U.S., only three of which are currently being sold, Bannan noted. Olympus declined to reveal the total number of endoscopes that might be affected by the recall, but said all were manufactured in Japan.
“Olympus has dedicated field specialists in the U.S. market deployed to help healthcare providers at all customer facilities train on and implement new inspection steps,” Bannan said.