FDA restricts imports of certain Olympus medical devices made in Japan

The FDA has issued an import alert to prevent future shipments of certain medical devices made in Japan by Olympus Medical Systems Corporation and its subsidiaries from entering the United States. The agency is alerting health care providers because it continues to have concerns about outstanding Quality System regulation violations, despite Olympus’ extensive and ongoing efforts to address compliance issues.

The FDA said it has issued warning letters and import alerts over current good manufacturing practice requirements and reporting requirements, including recalls the agency identified as the most serious type of recall. It is monitoring corrective actions related to the ongoing device quality violations. The agency encourages providers to report adverse events or suspected adverse events involving Olympus devices, and said it will keep providers and the public informed if new information becomes available.