Olympus received a warning letter from the US Food and Drug Administration on 7 October (US time), covering six facilities in Japan, Germany and the US, including Olympus Winter & IBE GmbH and Gyrus ACMI, Inc. On 19 October the FDA published an import alert on certain products made at three of the Japanese plants. According to Olympus's half-year report, imports of those designated products into the US are restricted until further notice.
The import alert is narrower than the warning letter and covers designated products, not all Olympus exports to the US. The company said in its earnings presentation that it has submitted its response to the warning letter and is continuing corrective work on its quality systems. It does not foresee additional impact on this year's consolidated results from the import alert, or a significant effect on customers.
What the restrictions have cost so far
Olympus's profit bridge puts the sales reduction from FDA-related import alerts and voluntary shipment halts at about ¥9bn in the July to September quarter and about ¥21bn for the half. The figure combines the two causes. An earlier import alert, published on 24 June 2025, covers certain products from a separate Japanese plant: some bronchoscopes, laparoscopes, ureteroscopes and endoscope reprocessors.
The company's own risk disclosure warns that slow or insufficient remediation could bring further FDA action and affect product supply. Management has added a new chief quality officer, who took the post on 1 August, and says it now uses company-wide, evidence-based criteria to judge when a corrective action is complete. The disclosures give no date for lifting the alerts or closing out the warning letter.
A refund flatters the numbers
For the six months to September, Olympus reported revenue of ¥509.6bn, up 12.2%, and operating profit of ¥85.0bn, up 84.2%. Part of that comes from a US tariff refund. Olympus Corporation of the Americas received a portion of the duties charged under the International Emergency Economic Powers Act after the US Supreme Court ruled them invalid. The company cut ¥17.1bn of tariff principal from cost of sales and booked ¥713mn of interest as finance income. Without the refund, operating profit was ¥67.8bn and profit attributable to owners was ¥39.4bn, against a reported ¥52.1bn.
The earnings release's adjusted operating profit of ¥95.8bn includes the refund. The presentation's adjusted figures strip it out.
Guidance: raised range, one-off inside
Olympus revised its full-year forecast from the previous version. The revenue range is now ¥1.0645tn to ¥1.076tn, with the floor raised from ¥1.055tn. Operating profit is guided at ¥155.0bn to ¥167.5bn and adjusted operating profit at ¥186.5bn to ¥199.0bn, both including the refund.
The presentation puts the full-year refund at about ¥20.3bn: ¥19.6bn in cost of sales and about ¥0.7bn in finance income. Excluding it, adjusted operating profit guidance is ¥167.0bn to ¥179.5bn. The earlier range was ¥160.5bn to ¥179.5bn, so the floor rose and the ceiling did not.