Olympus Corp shares plunged 14% Monday after the Japanese medical device maker slashed its full-year profit forecast, citing escalating costs and lingering product safety concerns. The stock tumbled to 1,603.5 yen, its lowest level since June 2025, as investors reacted to revised guidance projecting net profit between 50 billion yen and 59 billion yen—down from a prior estimate of 94 billion yen. Weak U.S. sales of key gastrointestinal endoscopes and regulatory compliance expenses further pressured margins.

The decline followed Olympus’ voluntary suspension of shipments to U.S. facilities after FDA re-inspections at eight sites in late 2025. While CEO Bob White noted most issues should resolve by the fiscal fourth quarter, the company faces ongoing costs from its 2023 Elevate compliance program, launched after FDA safety alerts. Revenue for Q4 rose marginally, but profit dipped 9% year-over-year amid higher operational expenses.

Analysts warn the FDA compliance overhaul could drag on earnings recovery, particularly if supply chain disruptions persist. The stock’s sell-off underscores market skepticism about Olympus’ ability to balance regulatory demands with profitability. Investors are now eyeing Q4 results as a potential turning point for the troubled medical giant.

Olympus’ profit warning ripples through Japan’s healthcare sector, highlighting broader challenges for firms navigating stringent U.S. medical device regulations. The 7733 ticker’s volatility signals uncertainty, with traders debating whether the revised guidance reflects temporary setbacks or deeper structural issues.