The FDA has barred the import of multiple medical devices manufactured by Olympus Medical Systems and its subsidiaries in Japan, citing ongoing violations of federal quality system regulations.
Despite efforts to correct compliance issues, the agency said it remains concerned over deficiencies at the company’s Aizu manufacturing site, according to a June 24 FDA news release.
The agency has issued Import Alert 89-04, which prevents Olympus devices including ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors from entering the U.S.
The FDA said the alert does not apply to related products such as connectors, single-use parts or replacement components used with impacted devices. Healthcare providers are advised that they may continue using the affected devices already in circulation if no issues have been identified.
