Date: June 24, 2025
The U.S. Food and Drug Administration (FDA) has issued an import alert on select medical devices manufactured by Olympus Medical Systems Corporation in Japan. This action comes after repeated Quality System Regulation (QSR) violations at Olympus’ Aizu manufacturing site. As a result, affected devices will be detained and refused entry into the U.S.
Devices Affected by the Import Alert
The import alert applies to specific models of:
- Ureterorenoscopes – used for urinary tract procedures
- Bronchoscopes – used for diagnostic procedures in the lungs
- Laparoscopes – used in abdominal and pelvic surgeries
- Automated Endoscope Reprocessors (AERs) – used to disinfect reusable scopes
Note: The alert does not apply to replacement parts, connectors, or single-use consumables.
What Health Care Providers Should Do
- Review your inventory: Use FDA’s AccessGUDID database to confirm if your device is affected.
- Continue safe use: If devices are working properly, they may be used. Do not cancel or delay procedures without patient discussion.
- Follow cleaning and reprocessing guidelines: Use Olympus’ official instructions. Do not use damaged or leaking devices.
- Schedule routine maintenance: Perform regular inspections as recommended by Olympus.
- Report adverse events: Use FDA MedWatch or follow your facility’s MDR procedures.
Why the FDA Took This Action
Despite ongoing dialogue, Olympus failed to resolve key compliance issues at its Aizu site. This includes violations of:
- Quality System Regulation (QSR)
- Current Good Manufacturing Practice (CGMP)
- Medical Device Reporting (MDR) requirements
Import Alert 89-04 allows the FDA to stop shipments of noncompliant medical devices before they reach U.S. healthcare providers.
Understanding Unique Device Identifiers (UDI)
Each affected device has a Unique Device Identifier (UDI) printed on the label or packaging. You can use the UDI or Device Identifier (DI) to search the AccessGUDID database and confirm if your device is part of the alert.
Report Problems to the FDA
If your facility experiences issues with any Olympus devices, take these steps:
- Submit a report through MedWatch
- Follow your facility’s MDR procedures if reporting is required
Reporting helps the FDA identify and respond to potential device safety risks quickly.
Contact FDA for More Information
For questions or clarification, contact the FDA’s Division of Industry and Consumer Education (DICE):
- Email: DICE@fda.hhs.gov
- Phone: 1-800-638-2041
Stay informed: The FDA will provide updates as more information becomes available.
