Olympus is recalling approximately 26,000 disposable EndoTherapy devices because of a packaging defect that could compromise their sterility.
The announcement affects113 models distributed in the U.S.since early 2019, with different numbers of SKUs available in different regions worldwide. The company is asking customers to quarantine the devices until they can be shipped back to Olympus.
The field safety notice said the defective seal may be difficult to detect with the naked eye but that the company had not received any complaints of injuries related to the problem. Recalled items include balloon catheters, forceps, knives, needles and stents.
“Olympus has taken this necessary voluntary product recall in the interest of patient safety,” company spokesperson Jennifer Bannan said in an email to Medical Design & Outsourcing. “Olympus continually reviews and assesses the safety of our medical devices and takes field action when necessary. As always, patient safety is our highest priority.”