FDA Update – June 25, 2025

Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers

We are seeing more and more regulatory actions against foreign companies because of lack of FDA QSR compliance. When a company has a violative inspection, and the FDA does not accept their corrective actions, the FDA can impose an import alert on all shipments entering the country.

This is a recent example:

The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus. Therefore, the FDA has issued import alerts to prevent future shipments of certain devices from entering the United States, including specific models of:

• Ureterorenoscopes, which are used to perform various diagnostic and therapeutic procedures within the urinary tract
• Bronchoscopes, which are used to perform various diagnostic and therapeutic procedures in the respiratory tract  
• Laparoscopes, which are used to perform various diagnostic and therapeutic procedures in the abdomen and pelvis  
• Automated endoscope reprocessors, which are used to reprocess various endoscopes

Recommendations

The FDA recommends that health care providers:

• Be aware of the FDA import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries, under which the devices will be refused entry into the U.S.:
  • Import Alert 89-04 for failure to meet quality system regulation requirements at Aizu, an Olympus manufacturing site in Japan
  • Be aware that the import alert does not apply to related products (such as replacement parts, connectors, or single use consumables) used with the devices subject to import alert.  
• If you are currently using devices subject to the import alert, you may continue using these devices if you are not experiencing any problems with the devices.
  • Follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components.
  • Do not use damaged devices or those that have failed a leak test, as they could be a potential source of contamination.
  • Develop schedules for routine inspection and periodic maintenance in accordance with manufacturer’s instructions.
• Discuss the benefits and risks associated with procedures involving these devices with your patients. 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.
• Complete prompt reporting of adverse events to help us identify and better understand the risks associated with these devices.

Background

The FDA has issued warning letters and import alerts where the FDA has determined that certain facilities were not in compliance with current good manufacturing practice (CGMP) requirements and various reporting requirements, including for recalls that the FDA identified as the most serious type of recall.

FDA Actions

The FDA has taken several actions related to quality system requirements and compliance concerns with Olympus.

The FDA is continuing to engage with Olympus to accelerate corrective actions related to ongoing violations and minimize risk to patients, and may take further action as appropriate. FDA takes seriously its role in assuring patients that medical devices are safe and effective.

The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.

Unique Device Identifier

The FDA established the unique device identification system (UDI) to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.

Reporting Problems to the FDA

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with medical devices manufactured by Olympus:

• You can submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

By promptly reporting adverse events, you can help the FDA identify and better understand the risks associated with medical devices.

If you have any questions on the above or need assistance in dealing and FDA upcoming inspection or responding to a 483 or Warning Letter and/or wants to be removed from an IMPORT ALERT list, mdi has extensive experience in helping companies addressing these areas.

Contact Information

For more information on this Import Alerts for Olympus Medical Devices or other FDA regulatory issues, please email us at: info@mdiconsultants.com and

ref: Import Alerts for Olympus Medical Devices.