Worth reading
67In focus
0–100. This measures how worthwhile something is to read, not how good or bad the company is.Direction
Neutral
Direction inferred from the company’s description.Scale
—
Displayed only when the document provides numerical figures.Wording
Conditional
How definitive the wording is.Decision and Details
U.S. Food and Drug Administration (FDA)Issuance of Import Alerts by the FDA
Decision19 October 2026 U.S. time (publication date)
Period CoveredUntil further notice
ImplementationUntil further notice (in effect)
Going forwardWork with the FDA to address the findings. Import restrictions will remain in place until further notice
Quantity / scaleFacilities covered: Olympus Medical Systems Corporation (Hinode), Shirakawa Olympus Corporation, and Aomori Olympus Corporation. Imports of designated products into the United States are restricted
Reason
To work transparently and constructively with the FDA to address the FDA's findings
Impact on Business Performance
The company does not expect any additional impact on consolidated results for the fiscal year ending March 2027, and there is no change to its consolidated earnings forecast
| Item | Details |
|---|---|
| Matter Covered | Issuance of Import Alerts by the FDA |
| Decision-Making Body | U.S. Food and Drug Administration (FDA) |
| Decision Date | 19 October 2026 U.S. time (publication date) |
| Implementation Date | Until further notice (in effect) |
| Period Covered | Until further notice |
| Quantity / scale | Facilities covered: Olympus Medical Systems Corporation (Hinode), Shirakawa Olympus Corporation, and Aomori Olympus Corporation. Imports of designated products into the United States are restricted |
| Impact on Business Performance | The company does not expect any additional impact on consolidated results for the fiscal year ending March 2027, and there is no change to its consolidated earnings forecast |
| Reason | To work transparently and constructively with the FDA to address the FDA's findings |
| Related previous disclosures | Previously disclosed consolidated earnings forecast for the fiscal year ending March 2027 (specific date and title: Not disclosed) |
| Future plans | Work with the FDA to address the findings. Import restrictions will remain in place until further notice |
Items this document does not state (2)
AmountGoverning Rule
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The company stated that it will work transparently and constructively with the FDA to address the FDA's findings.
How to read this page
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Corrections happenIf the company reissues this disclosure, the page is rebuilt from the corrected version and the revision number moves up.