Olympus Corporation announced on October 13, 2026, that it has received a warning letter from the U.S. Food and Drug Administration dated October 7, 2026. The company said the letter follows FDA inspections of its facilities in the United States, Japan and Europe conducted in late 2025.
According to Olympus, the items in the warning letter primarily concern its quality management system and related processes. The company said it would submit a comprehensive response within 15 business days of receiving the letter and provide periodic updates until the FDA determines that its actions are adequate.
Olympus also said that customers do not need to take any additional action because of the letter, and that the letter does not restrict its ability to produce, market or distribute products, does not require a recall, and does not restrict its ability to seek FDA 510(k) clearance for new products. Those statements are the company’s own. This article is based on the company’s announcement; CBW will update it if the FDA publishes the letter.
Which Olympus Facilities Were Inspected?
Olympus listed six facilities in its announcement:
- Olympus Medical Systems Corporation in Hachioji, Japan
- Olympus Medical Systems Corporation in Hinode, Japan
- Aomori Olympus Co., Ltd., in Japan
- Shirakawa Olympus Co., Ltd., in Japan
- Olympus Winter & IBE GmbH in Hamburg, Germany
- Gyrus ACMI, Inc., in Brooklyn Park, in the United States
How the Letter Fits Olympus’s Regulatory History
The October 2026 letter is not the first FDA compliance action involving Olympus. In January 2023, the FDA announced two warning letters to Olympus Medical Systems Corporation and its subsidiary Aizu Olympus Co., Ltd., citing violations of medical device reporting requirements and quality system regulations for endoscopes and endoscope accessories. The agency said adequate reporting is necessary so that infections or reprocessing failures involving reusable devices reach the FDA for evaluation.
In June 2025, the FDA told health care providers it had issued import alerts for certain Olympus devices manufactured in Japan, citing outstanding quality system violations. The alerts covered specific models of ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors. The FDA said facilities already using those devices could continue to use them if they were not experiencing problems.
Duodenoscopes, the specialized scopes used in ERCP procedures on the bile and pancreatic ducts, have their own history. In December 2018, Olympus Medical Systems Corporation pleaded guilty to distributing misbranded medical devices after failing to file required reports about infections in Europe connected to its TJF-Q180V duodenoscope. The court fined the company $80 million and ordered $5 million in criminal forfeiture. That money was a criminal penalty, not compensation for patients.
In July 2023, Olympus began a corrective action for its TJF-Q190V duodenoscope after reports of infections and positive cultures. FDA’s recall record says the notice reminded facilities to follow the reprocessing instructions, pointed them to an updated reprocessing manual and emphasized required inspections. The record lists the recall as open.
What the Warning Letter Does Not Show
A warning letter describes regulatory concerns about a company’s systems and processes. Based on what Olympus has disclosed, the October 2026 letter is about quality management, and nothing in the announcement links it to a particular infection or a particular device model.
The FDA has also said that the risk of infection from inadequate reprocessing is relatively low, and that procedures should not be canceled or delayed without a discussion of the benefits and risks between a patient and their health care provider. Anyone with a procedure scheduled should raise questions with their own doctor.
None of these actions, on its own, establishes that a specific patient’s infection was caused by a contaminated scope. That question turns on the procedure records, the device used, the organism identified and the timing of the illness.
Developed an Infection After a Scope Procedure?
A serious infection or sepsis after an ERCP or another endoscopic procedure can raise hard questions about what happened. Our Olympus scope infection lawsuit page explains how these claims are reviewed, the difference between duodenoscopes and other endoscopes, and which records can help.
You do not need to know the scope’s model number or have every medical record before reaching out. Request a free case review.
Submitting information does not create an attorney-client relationship. Each potential claim is evaluated individually, and no outcome can be promised.
This article is general information about how these cases work. It is not legal advice, it does not create an attorney-client relationship, and no two claims are alike. If something here sounds like your situation, the useful next step is a conversation about the facts.