Olympus® Scope Infection Lawsuit

Lawsuits have been filed against Olympus Medical Corp by people who developed severe infections after undergoing medical procedures involving reusable endoscopes, duodenoscopes, and other scopes that were allegedly contaminated with biological material from previous patients.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Olympus scope infection cases in all 50 states. If you or a loved one developed a serious bacterial infection after a colonoscopy, endoscopy, bronchoscopy, or ERCP performed with a reusable Olympus scope, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

What is the Problem?

Olympus recalled about 7,023 Olympus TJF-Q190V duodenoscopes due to continued reports of positive cultures and infections. Olympus also issued a second recall for 988,700 single-use distal covers due to problems with device design.

Olympus Duodenoscopes Recalled After Continued Reports of Infections

In November 2025, the FDA issued a recall for about 7,023 Olympus TJF-Q190V duodenoscopes due to issues with contamination. According to Olympus:

“Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing.”

The recall describes a pattern of patients who suffered infections as a result of persistent contamination on reusable Olympus scopes. These reports have surfaced more than a decade since 2015, when the FDA issued a warning letter about the issue of persistent contamination.

What Is a Duodenoscope?

A duodenoscope is a long, flexible tube with a light and a camera on the end. Doctors use these scopes to look deep inside a patient’s digestive system. The tube is inserted through through the patient’s mouth, throat, and stomach, into the upper part of the intestine.

Every year, duodenoscopes are used in over 500,000 ERCP procedures in the U.S., and after the procedure the scope is sterilized and reused. Unfortunately, the nooks and crannies on the moveable parts of the scope can potentially harbor residual microbes and contaminants.

If these contaminants survive the sterilization phase, they can infect the next patient who undergoes a procedure using the scope. According to the FDA:

“If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain in a duodenoscope when it is used on a subsequent patient.”

Sterilization is not always easy. The scopes are designed with narrow internal channels, moving parts, and a forceps elevator mechanism near the tip. These parts can be difficult to inspect and sanitize, which increases the risk that a scope that looks clean still has biological material from the last person it was used on.

What Infections Have Been Linked to Contaminated Scopes?

Contaminated reprocessed endoscopes have been linked to a wide range of health risks, including:

Carbapenem-resistant Enterobacterales (CRE)
Vancomycin-resistant Enterococcus (VRE)
Clostridioides difficile (C. diff)
Pseudomonas aeruginosa
E. coli infections
Bloodstream infections and sepsis
Pneumonia
Organ failure and septic shock
Other drug-resistant bacterial infections

Examples of Olympus Scope Products

TJF-Q190V EVIS EXERA III duodenovideoscope, subject to the open November 2025 recall
MAJ-2315 single use distal cover, used with the TJF-Q190V, subject to the July 2026 recall
CF-HQ190L colonoscope, named in a 2026 product liability complaint
TJF-Q180V duodenoscope, the model at the center of the 2018 federal criminal case
OER-Pro, OER-Elite, OER-MINI, and OER-AW automated endoscope reprocessors
Bronchoscopes, ureterorenoscopes, laparoscopes, and rhino-laryngoscopes named in the 2025 import alert

Why Did the FDA Issue an Import Alert on Olympus Devices?

On June 24, 2025, the FDA sent a letter to health care providers about an import alert on certain Olympus medical devices made at a facility in Japan.

The import alert prevented these scopes and other devices from entering the U.S., due to concerns about outstanding Quality System regulation violations by Olympus. The FDA said it issued the import alert despite extensive efforts to address compliance issues.

Import Alert 89-04 for the Aizu manufacturing site only involves specific models of bronchoscopes, ureterorenoscopes, laparoscopes, and automated endoscope reprocessors. The FDA also issued warning letters for facilities that were out of compliance with Good Manufacturing Practice (GMP) requirements, including for recalls.

What Happened in the Olympus Criminal Case?

In December 2018, Olympus Medical Systems and a former senior executive pleaded guilty to federal charges for failing to file adverse event reports as required by the FDA. These reports involved patients who developed infections after undergoing procedures with the Olympus TJF-Q180V duodenoscope. The FDA ordered Olympus to pay a civil penalty of $80 million. The company also forfeited another $5 million.

What Do Olympus Scope Lawsuits Claim?

More recently, Olympus has been hit several lawsuits involving patients who developed infections. Many of the lawsuits that were filed in 2026 claim that Olympus reusable scopes are defective because they cannot be reliably sterilized and may expose new patients to biological material from previous patients, even when hospitals follow the Olympus’s sterilization and reprocessing instructions.

For example, in June 2026 a wrongful death lawsuit was filed in the U.S. District Court for the Western District of Washington by the widow of a man who underwent an ERCP with an Olympus TJF-Q190V duodenoscope in June 2023. He died just 16 days later after developing a vancomycin-resistant Enterococcus infection that was not present on his extensive bloodwork before the procedure.

Both lawsuits involve claims of defective design, failure to warn, manufacturing defect, negligence, gross negligence, breach of warranty, negligent misrepresentation, and fraudulent concealment.

How Do I Find Out Which Scope Was Used in My Procedure?

Identifying the device used in your procedure is important for these claims. The records may name the manufacturer, model, and serial number:

The procedure report and operative report
Nursing notes and equipment logs from the day of the procedure
Endoscope tracking records, which many hospitals maintain to link a specific scope to a specific patient
Reprocessing and disinfection logs
Automated endoscope reprocessor service and maintenance records
Infection control reports from the facility

Culture results, blood work from before and after the procedure, discharge summaries, and antibiotic records also matter.

Who May Qualify for an Olympus Scope Infection Lawsuit?

Our lawyers are reviewing potential claims for people nationwide who developed a serious infection after a procedure involving a reusable medical scope. You may qualify if:

You underwent an ERCP, colonoscopy, upper endoscopy, or bronchoscopy
The procedure involved a reusable surgical scope
You developed a serious infection in the weeks following the procedure
The infection required hospitalization, IV antibiotics, intensive care, or additional procedures
Or a family member died from infection-related complications after a scope procedure

Do I Have an Olympus Scope Lawsuit?

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Olympus Scope Infection Lawsuit