by
Gus Iversen, Editor in Chief | July 02, 2025
The U.S. FDA has issued import alerts on certain medical devices produced by Olympus Medical Systems Corporation and its subsidiaries in Japan, citing ongoing quality system violations.
According to the agency’s June 24 letter to health care providers, the restrictions apply to specific models of ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors manufactured at Olympus’ Aizu facility. The devices will be refused entry into the U.S. under Import Alert 89-04, which covers failures to meet Quality System Regulation requirements.
The FDA is providing a
list of impacted devices, which shows 58 individual items.
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While the FDA has been in extended discussions with Olympus to resolve compliance issues, it determined that violations remain unresolved and significant enough to warrant the import alerts. The action does not apply to related accessories, such as replacement parts or single-use consumables, used with the affected devices.
The agency advises that facilities may continue using Olympus devices already in inventory, provided no problems have been reported. Health care providers are instructed to adhere to all cleaning and reprocessing protocols, avoid using damaged or leaking devices, and follow manufacturer-recommended inspection and maintenance schedules.
“The FDA does not recommend that procedures be canceled or delayed without discussion of the benefits and risks between the health care provider and patient,” the agency stated.
Olympus has previously received warning letters and has been subject to regulatory scrutiny for noncompliance with current good manufacturing practices and recall reporting standards. The FDA noted that it continues to engage with the company to expedite corrective actions and mitigate patient risk.
Healthcare providers are encouraged to review the list of impacted models and Unique Device Identifiers (UDI), and to promptly report adverse events linked to these devices to improve postmarket surveillance.
The FDA said it will provide further updates if new information becomes available.
