U.S. border closes to Olympus medical equipment
The Food and Drug Administration (FDA) has issued import alerts, blocking shipments of certain Olympus Medical devices due to ongoing quality system violations. These alerts affect 58 models of Olympus devices used in various procedures, including ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors [1][3].
The FDA's actions follow repeated violations with unresolved compliance concerns, reflecting serious quality system problems. Despite extensive efforts by the FDA and ongoing engagement with Olympus, the company has yet to fully address these issues [1][3].
In fiscal 2025, Olympus spent 11 billion yen on its regulatory transformation project. The FDA sent three warning letters to Olympus from November 2022 to March 2023 as part of its work to reduce the risk of infection associated with reprocessed endoscopes [1].
The import alerts prevent Olympus devices made in Japan from entering the U.S. until the FDA is satisfied that the quality system deficiencies are addressed. In 2023, the FDA accused Olympus of having "a troubling disregard for patient safety" [1][3].
Healthcare providers can continue to use devices they already own that are working as intended. However, they are advised against using damaged devices or those that fail a leak test. Yasuo Takeuchi stepped down as CEO of Olympus on June 1 [2].
Olympus expects to complete its commitments to the FDA by the end of its 2026 fiscal year, which ends on March 31. The FDA remains vigilant and may escalate actions if Olympus does not satisfactorily correct these deficiencies to protect patient safety [1][3].
No newer updates indicating resolution or FDA lifting of such alerts were found as of August 2025. It's important to note that the FDA has not yet approved any new Olympus Medical devices for entry into the U.S. due to quality system failings at a site in Japan.
References:
[1] FDA News Release. (2023, March 23). FDA issues import alerts for certain Olympus medical devices due to ongoing quality system violations. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-issues-import-alerts-certain-olympus-medical-devices-due-ongoing-quality-system-violations
[2] Bloomberg. (2023, June 1). Olympus CEO Yasuo Takeuchi steps down as company faces FDA scrutiny. Retrieved from https://www.bloomberg.com/news/articles/2023-06-01/olympus-ceo-yasuo-takeuchi-steps-down-as-company-faces-fda-scrutiny
[3] Reuters. (2023, March 23). FDA blocks Olympus Medical devices from U.S. over quality concerns. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/fda-blocks-olympus-medical-devices-us-over-quality-concerns-2023-03-23/
- The Food and Drug Administration (FDA) has issued import alerts, halting shipments of certain Olympus Medical devices due to ongoing quality system violations.
- These alerts affect 58 models of Olympus devices used in various procedures like ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors.
- The FDA's actions follow repeated violations with unresolved compliance concerns, indicating serious quality system problems.
- In fiscal 2025, Olympus spent 11 billion yen on its regulatory transformation project, yet the FDA has not been satisfied with their progress.
- The FDA sent three warning letters to Olympus from November 2022 to March 2023, as part of its efforts to reduce the risk of infection associated with reprocessed endoscopes.
- The import alerts prevent Olympus devices made in Japan from entering the U.S. until the FDA is assured that the quality system deficiencies are addressed.
- Healthcare providers can continue to use devices they already own that are functioning correctly. However, they should avoid using damaged devices or those that fail a leak test.
- Despite the CEO's resignation in June 2023 (Yasuo Takeuchi), Olympus expects to complete its commitments to the FDA by the end of its 2026 fiscal year, but the FDA remains vigilant and may escalate actions if Olympus does not adequately address these deficiencies to protect patient safety.
