Texas Olympus Scope Infection Lawsuit

Lawsuits are being filed by patients who were injured by Olympus duodenoscopes and other scopes that were contaminated with biological material from previous patients.

Need a Texas Olympus Scope Infection Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you developed a serious injury or infection from a reusable Olympus scope that was contaminated with a “superbug” or other disease, contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.

Do I Have a Lawsuit?

Our law firm is reviewing cases for people who had any of the following endoscopic procedures from 2018 to the present day:

• Laparoscopy
• Colonoscopy
• ERCP
• Bronchoscopy
• Upper Endoscopy
• Ureteroscopy
• Hysteroscopy
• Sinus Endoscopy
• Cystoscopy

You (or your loved one) must have suffered a serious injury, infection, or complication due to a scope that was contaminated with biological material, failed due to a design flaw, or medical errors.

Here are some examples of serious injuries:

• Diagnosis of a “superbug” infection (for example: drug-resistant infection such as CRE or E. coli) within 180 days of procedure
• Organ damage or perforation
• Tissue damage or perforation
• Dislodging or breaking of endoscopic device
• Severe bleeding (hemorrhaging) resulting in major complications, hospitalization, or blood transfusion
• Sepsis or bacteremia
• Bacterial infection requiring hospitalization within 90 days of procedure
• Pneumonia or severe pulmonary infection within 90 days of procedure
• Tuberculosis within 90 days of procedure
• HIV diagnosis within 90 days of procedure
• Death from infection due to a contaminated scope, or component failure

Olympus Duodenoscopes Remain Under an Open FDA Recall

In November 2025, the FDA issued a Class II recall for 7,023 Olympus TJF-Q190V duodenoscopes due to “continued reports of positive cultures and infections” on reusable scopes that had been reprocessed (which means they were supposedly “sterilized” between patients).

Olympus issued the recall to update the instructions for reprocessing “to minimize potential deviations” in response to reports of scopes that were still contaminated after reprocessing.

In July 2026, Olympus announced another Class II recall for 988,700 Olympus single-use distal covers that were used with Olympus TJF-Q190V duodenoscopes. These covers are designed to be attached to the scope to cover the distal end of the insertion tube and around the forceps elevator, duodenoscope and accessories.

Long History of Olympus Scope Infection Reports

Federal health officials have been aware of issues with contaminated scopes for over a decade. In 2013, the CDC alerted the FDA to a possible connection between duodenoscopes and an outbreak of multi-drug-resistant bacterial infections. Alarmingly, these infections occurred at facilities that confirmed they were following Olympus’s reprocessing instructions for disinfecting the scopes.

In February 2015, the FDA issued a Safety Communication to warn health care facilities about the challenges of sterilizing scopes with complex designs.

In October 2015, the FDA ordered Olympus, Fujifilm, and Pentax to conduct post-market surveillance studies to evaluate real-world contamination rates. Early results in December 2018 showed contamination rates that were higher than expected.

Olympus Pays $85 Million for Failing to Report Serious Infections

In December 2018, Olympus and a former senior executive were ordered to pay $85 million in fines and criminal forfeiture for “failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the duodenoscopes in the U.S. despite those failures.”

What Is the Risk?

A duodenoscope is a medical device that looks like a long tube with a light and a camera on the end. It is inserted through the patient’s mouth and threaded into their intestines. The FDA reports these scopes are used in more than 500,000 ERCP procedures in the U.S. each year. The scopes are reprocessed and reused. If the reprocessing step fails, biological material from on one patient can travel to the next patient. This may result in a severe infection.

Types of Infections Linked to Contaminated Scopes

Contaminated medical scopes may lead to serious infections, for example:

• Carbapenem-resistant Enterobacterales (CRE)
• Vancomycin-resistant Enterococcus (VRE)
• Clostridioides difficile, commonly called C. diff
• Pseudomonas aeruginosa
• E. coli
• Bloodstream infections, sepsis, and septic shock
• Pneumonia and organ failure
• And more

Types of Olympus Endoscopes

Here are some examples of scopes manufactured by Olympus:

• TJF-Q190V EVIS EXERA III duodenovideoscope
• MAJ-2315 single use distal cover
• CF-HQ190L colonoscope
• TJF-Q180V duodenoscope
• OER-Pro, OER-Elite, OER-MINI, and OER-AW automated endoscope reprocessors
• Bronchoscopes, ureterorenoscopes, and laparoscopes named in the 2025 import alert

FDA Import Restriction for Olympus Scopes

In June 2025, the FDA issued Import Alert 89-04 for certain Olympus scopes that were manufactured at the Aizu facility in Japan, including bronchoscopes, ureterorenoscopes, laparoscopes, and automated endoscope reprocessors. According to the FDA:

“Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus.”

In a letter to health care providers, the FDA said it issued warning letters and import alerts when it determined that “certain facilities were not in compliance with current good manufacturing practice (CGMP) requirements and various reporting requirements, including for recalls that the FDA identified as the most serious type of recall.”

Olympus Scope Lawsuits

Lawsuits have been filed against Olympus by people who developed serious infections after undergoing endoscopic procedures. These lawsuits claim that Olympus’s reusable scopes cannot always be sterilized reliably, even when hospital staff follow the Olympus’s reprocessing instructions exactly as written.

One example is a wrongful death lawsuit that was filed by the widow of a man who underwent an ERCP with an Olympus TJF-Q190V duodenoscope in June 2023. He developed a VRE infection that was not on his bloodwork before the procedure, and died 16 days later of organ failure and septic shock. The lawsuit was filed in June 2026 in the U.S. District Court for the Western District of Washington.

Legal Help for Scope Infection Victims in Texas

Texans who were harmed by contaminated medical scopes and other devices may be eligible to seek justice thought a lawsuit. Filing deadlines apply, so do not wait to have your case reviewed.

Need a Texas Olympus Scope Lawsuit?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years of experience, participation in over 600 jury trials, and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.