FDA issues import alert on Olympus endoscopic devices over quality violations

The U.S. Food and Drug Administration has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries.

The alert applies to a range of products, including ureterorenoscopes, bronchoscopes, laparoscopes, automated endoscope reprocessors, ingestible telemetric gastrointestinal capsule imaging systems, and enteroscopes.

The action follows ongoing concerns about unresolved Quality System regulation violations at Olympus, and the FDA will refuse entry of the listed devices into the United States.

Health care providers are advised to review their inventories for the affected models and be aware that shipments of these devices will be denied entry.