Olympus Scopes Lawsuit: Endoscope and Duodenoscope Infections and Injuries

On June 24, 2025, the FDA issued import alerts for dozens of Olympus products manufactured at a facility in Japan, citing persistent violations of quality regulations and reporting requirements. The alerts block 58 particular ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors from entering the United States.

In a November 2022 warning letter, the FDA detailed investigative findings that a facility that manufactures Olympus devices, run by subsidiary Aizu Olympus Co., Ltd., violated multiple “Quality System” regulations. The violations included the following:

• Failure to fully test and validate the designs of its products
• Failure to properly document and test all steps of the manufacturing process to ensure they are safe
• Failure to enact written procedures for reporting issues and adverse effects related to its medical devices

The FDA’s Center for Devices and Radiological Health explained in a January 2023 release that the warning letters issued to Olympus and its subsidiaries were part of an effort to ensure manufacturers of reprocessed endoscopes followed new guidelines instituted in response to infections caused by the re-use of these devices.

Now, the import alerts specifically mention the Aizu facility for ongoing failures to meet FDA requirements. Issues with the manufacturing process may have led to additional infections, and a lack of proper reporting may have hindered efforts to implement changes that could have protected patients.