Olympus Medical Device Warning Letter Follows FDA Inspections of Six Manufacturing Facilities

FDA cites manufacturing quality concerns at six Olympus facilities, adding to years of regulatory problems involving the company’s endoscopes and other medical devices.

Federal regulators have renewed scrutiny of Olympus’ medical device manufacturing practices, adding to longstanding safety concerns involving the company’s endoscopes and other medical equipment.

In a press release issued on October 13, Olympus announced it had received a warning letter from the U.S. Food and Drug Administration (FDA) following inspections of six manufacturing facilities in the United States, Japan and Europe.

According to Olympus, the latest warning primarily concerns quality management systems and related manufacturing processes at facilities that include endoscope production sites in Japan and company subsidiaries in Minnesota and Germany.

Endoscope Risks

Endoscopes are medical instruments equipped with miniature cameras, lights and narrow internal channels that allow doctors to examine and treat internal organs without open surgery. They are used during procedures such as endoscopic retrograde cholangiopancreatography (ERCP), colonoscopies, upper endoscopies and bronchoscopies.

Because many endoscopes are reused on multiple patients, they must undergo thorough cleaning and disinfection between procedures. However, the FDA has repeatedly warned that the complex designs of certain scopes can make it difficult to eliminate potentially dangerous bacteria.

These longstanding safety concerns have become central to Olympus scope infection lawsuits, which allege the manufacturer failed to adequately address design defects and contamination risks that may allow dangerous bacteria to spread between patients during certain medical procedures.

2026 Olympus Warning Letter

The warning letter, dated October 7, stems from inspections conducted in late 2025 and primarily involves deficiencies in the company’s quality management systems and related manufacturing processes.

The facilities include four locations in Japan, a manufacturing site in Hamburg, Germany, and a Gyrus ACMI facility in Brooklyn Park, Minnesota. Olympus did not disclose the specific violations cited in the warning letter or identify whether particular medical devices were affected.

Olympus indicated that it has been working to correct the problems since the inspections concluded and plans to submit a comprehensive response to the FDA within 15 business days of receiving the warning. The company will also provide periodic updates until regulators determine that its corrective actions are adequate.

“We take the concerns identified in the Warning Letter seriously and are fully committed to resolving these matters with urgency and rigor.”

— Bob White, Olympus CEO

The company emphasized that the warning does not require any product recalls or restrict its ability to manufacture, market or distribute medical devices. Olympus also maintains that customers do not need to take additional action and that its products remain safe when used according to instructions.

Olympus Medical Device Warnings

The latest warning letter is part of a broader history of FDA regulatory actions involving Olympus endoscopes, including earlier investigations into whether certain reusable medical scopes can be adequately disinfected between patients.

In 2015, the FDA warned that duodenoscopes contain small moving parts and hard-to-reach areas where contamination may persist despite recommended disinfection procedures. The agency subsequently ordered Olympus, Fujifilm and Pentax to study contamination rates, issuing warning letters in 2018 after the manufacturers failed to provide sufficient data.

Results released by the FDA in December 2018 indicated that some duodenoscopes continued to test positive for contamination after undergoing the cleaning procedures intended to make them safe for reuse.

Olympus agreed to pay $85 million in criminal penalties that same year after pleading guilty to failing to report serious duodenoscope-related infections to the FDA, including an $80 million fine and $5 million in criminal forfeiture.

The FDA later recommended transitioning to duodenoscopes with improved designs in 2019 and issued another warning letter to an Olympus manufacturing facility in Japan in 2022 over quality control deficiencies involving endoscopes and reprocessing equipment.

In June 2025, the FDA restricted imports of certain Olympus medical devices manufactured in Japan, citing unresolved quality control violations. The restrictions affected specific endoscopes and automated reprocessing equipment, preventing new shipments of those devices from entering the United States.

Olympus Scope Lawsuits

Individuals have also filed Olympus scope infection lawsuits claiming contaminated endoscopes can cause serious infections, sepsis, organ failure and death.

Olympus endoscope lawyers are investigating potential claims nationwide on behalf of patients who developed serious infections or families who lost loved ones following an ERCP or another medical procedure involving a potentially contaminated reusable endoscope.

Individuals may qualify to pursue an Olympus endoscope lawsuit if they or a loved one experienced any of the following complications after a colonoscopy, endoscopy, ERCP or bronchoscopy:

Contaminated scope infection product liability lawsuits are pursued on a contingency fee basis, meaning individuals pay nothing upfront for an attorney to evaluate and investigate their case. Legal fees and expenses are only collected if compensation is recovered through a settlement or other successful outcome.

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