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# FDA Olympus Scope Import Alerts
- URL: https://www.fdaweb.com/fda-olympus-scope-import-alerts/
- Published: 2025-06-24T12:00:00.000Z
- Updated: 2026-09-14T15:15:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159406

FDA has alerted healthcare providers to agency import alerts for certain medical devices manufactured by Olympus Medical Systems and its subsidiaries. An online [notice](https://www.fda.gov/medical-devices/letters-health-care-providers/import-alerts-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the alerts apply to specific models of the firm’s uteroenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors.

“Despite extensive and ongoing efforts to address compliance issues,” the notice says, “FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus.”

The notice says the agency has taken several actions related to quality system requirements and compliance concerns with the company. It says FDA is continuing to engage with Olympus to accelerate corrective actions related to ongoing violations and minimize the risk to patients.