U.S. Customs prevent Olympus medical devices from importation following FDA's order
The Food and Drug Administration (FDA) has issued import alerts to prevent the entry of specific Olympus medical devices into the United States. The affected devices, which include bronchoscopes, laparoscopes, ureterorenoscopes, and automated endoscope reprocessors, are manufactured at the Aizu facility in Fukushima, Japan.
The FDA's action was prompted by unresolved quality system issues and compliance concerns related to Quality System Regulation (QSR), Current Good Manufacturing Practice (CGMP), and Medical Device Reporting (MDR) requirements.
Olympus, the device manufacturer, has acknowledged the FDA's import alerts and is working diligently to address the concerns. The company aims to ensure that its products meet the highest quality standards. However, as of June 2025, Olympus has not yet resolved the compliance issues. The FDA continues to engage with Olympus to implement corrective actions and may take further action as necessary.
The affected devices represent a small portion of Olympus' revenue, accounting for about 1% of its consolidated revenue for the fiscal year ending March 2025. The import block does not impact the sale of these devices in other countries.
Healthcare providers are advised that they can continue using existing devices unless they experience issues. The FDA does not recommend canceling procedures without discussing the benefits and risks with patients. Providers are also advised to follow labeling and reprocessing instructions for the devices.
The FDA's concerns stem from outstanding Quality System regulation violations by Olympus, a fact that has not been revised. The FDA issued the import alerts on Tuesday to prevent these devices from reaching customers in the U.S.
Since November 2022, the FDA has sent three warning letters to Olympus. No new warning letters have been sent since March 2023. Yasuo Takeuchi, the former CEO of Olympus, stated during a May earnings call that the company expects to complete its commitments to the FDA by the end of its 2026 fiscal year, with the fiscal year ending March 31.
Olympus spent 11 billion yen on its regulatory transformation project in fiscal 2025. It's important to note that the FDA advises against using damaged devices or those that fail a leak test, a recommendation that remains unchanged.
The FDA maintains its oversight to ensure compliance and safety standards are met for medical devices entering the U.S. market. The agency continues to work with Olympus to accelerate corrective actions related to ongoing violations and minimize risk to patients. As of now, the FDA has not issued any new import alerts affecting Olympus devices since the ones mentioned earlier.
- The Food and Drug Administration (FDA) has issued import alerts to prevent certain Olympus medical devices from entering the United States.
- The affected devices, like bronchoscopes, laparoscopes, ureterorenoscopes, and automated endoscope reprocessors, are manufactured at Olympus' Aizu facility in Fukushima, Japan.
- The FDA's action was due to unresolved quality system issues and compliance concerns related to Quality System Regulation (QSR), Current Good Manufacturing Practice (CGMP), and Medical Device Reporting (MDR) requirements.
- Olympus, the device manufacturer, is diligently addressing the FDA's concerns, aiming to ensure its products meet the highest quality standards.
- As of June 2025, Olympus has not yet resolved the compliance issues, with the FDA continuing to engage with the company to implement corrective actions.
- The affected devices account for about 1% of Olympus' consolidated revenue for the fiscal year ending March 2025, with the import block not affecting the sale of these devices in other countries.
- Healthcare providers are advised to continue using existing devices unless they encounter issues and to follow labeling and reprocessing instructions for the devices.
- The FDA maintains its oversight to ensure compliance and safety standards are met for medical devices entering the U.S. market, working with Olympus to accelerate corrective actions related to ongoing violations and minimize risk to patients.
