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◉ Olympus Scope Claims

Exposed. Infected. Hospitalized.

The FDA has confirmed what patients already lived through: Olympus knew its reusable endoscopes harbored deadly bacteria and kept selling them anyway. If you or a loved one developed a serious infection after a routine scope procedure, you may be the victim of corporate negligence. Fill out the form below to see if you qualify for compensation.

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Legal Criteria

These Are the Injuries Linked to Contaminated Olympus Scopes.

To qualify, you must have undergone a scope or endoscopic procedure and developed a documented infection within one year. The following harms have been reported in connection with contaminated Olympus devices and are recognized in ongoing litigation.

Sepsis / Septic Shock

Bloodstream infection following a scope procedure requiring IV antibiotics or ICU care.

Bloodstream Infection (Bacteremia)

Including drug-resistant “superbug” infections that entered through a contaminated device.

Urinary Tract Infection

Linked to contaminated accessories used during cystoscopy, ureteroscopy, or related urologic procedures.

Respiratory / Lung Infection

Pneumonia or airway complications following a bronchoscopy.

Eating Disorders

Serious complications requiring repeat procedures or long-term care.

Wrongful Death

Loss of a family member following a documented scope-related infection.
To qualify, the following must generally apply:
  • You underwent an endoscopy, colonoscopy, ERCP, bronchoscopy, cystoscopy, ureteroscopy, choledochoscopy, or hysteroscopy
  • The procedure occurred on or after 2015
  • You developed a documented infection, sepsis, positive culture, or related complication generally within 30 days of the procedure
  • You were treated with IV antibiotics, hospitalized, admitted to the ICU, or suffered a lasting injury or death
  • Your procedure may have involved a duodenoscope, bronchoscope, or accessory device made by Olympus

Legal Criteria

It’s Not Your Fault.
It’s the Design.

Reusable scopes were never supposed to carry bacteria from one patient to the next, but regulators say Olympus’s own design made that nearly impossible to prevent, even when hospitals followed the cleaning instructions exactly as written.

The Defect

A Design That Traps Bacteria

Olympus scopes contain internal channels and mechanical components that can trap bacteria and biological material between uses. Standard hospital sterilization, performed correctly, could still leave the device contaminated for the next patient.
The Cover-Up

Warnings That Came Too Late

Olympus issued an urgent correction to the reprocessing instructions for its TJF-Q190V duodenoscope after post-market surveillance data raised new safety concerns and later told providers that visual inspection alone, the standard practice for years, was not enough to catch contamination, introducing a requirement for 10x magnification tools instead.
The Result

Patients Paid the Price

Between 2024 and late 2025, Olympus reported two deaths and five serious injuries tied to infections or positive bacterial cultures involving its current-generation scopes, and separately, an FDA update disclosed 120 injuries and one death connected to a contaminated Olympus endoscope accessory.

$85 M

The federal penalty a judge ordered Olympus to pay after the company admitted it hid infection risks from the FDA instead of protecting patients.

Government Actions, Verdicts & Case History

$731M+ and Counting

Federal Actions & Penalties Against Olympus

$646 Million

Washington, D.C. – March 1, 2016
Olympus Corp. of the Americas paid a record $646 million to resolve criminal and civil charges under the Anti-Kickback Statute, False Claims Act, and Foreign Corrupt Practices Act. Federal prosecutors described a years-long scheme in which Olympus paid kickbacks to doctors and hospitals to boost endoscope sales, generating over $600 million in revenue and $230 million in gross profits. The settlement remains the largest ever paid by a medical device company under the Anti-Kickback Statute.

$85 Million

Criminal Guilty Plea

Newark, NJ – December 10, 2018

Olympus Medical Systems Corporation and its former senior regulatory executive, Hisao Yabe, pleaded guilty in Newark Federal Court to three criminal counts of distributing misbranded medical devices. Olympus admitted it failed to file FDA-required adverse event reports documenting serious patient infections connected to its TJF-Q180V duodenoscope, which the company had known about since 2012. The court ordered $80 million in fines and $5 million in criminal forfeiture.

FDA Class I Recall

MAJ-891 Forceps/Irrigation Plug

FDA – January 29, 2025
The FDA classified a Class I recall, its most serious designation, for the Olympus MAJ-891, a reusable endoscope accessory linked to 120 injuries and 1 death. The FDA warned that contamination from improper reprocessing could result in infection, urinary tract infection, sepsis, and death. The device had been used with cystoscopes, ureteroscopes, choledochoscopes, and hysteroscopes.

FDA Import Alert

58 Device Models Blocked

FDA – June 24, 2025
The FDA issued import alerts blocking 58 models of Olympus medical devices manufactured in Japan from entering the United States, citing ongoing violations of quality system regulations. Affected devices included ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. The agency stated it “continues to have concerns related to outstanding Quality System regulation violations by Olympus.”

FDA Class I Recall

ViziShot 2 FLEX Needle

FDA – September 19, 2025
The FDA posted a Class I recall for the Olympus ViziShot 2 FLEX (19G) EBUS-TBNA needle after device components were found to detach during procedures, potentially ejecting into patients’ airways. The recall was linked to 40 reported injuries and 1 death.

FDA Warning Letters

Endoscope Manufacturing Failures

FDA – January 10, 2023
The FDA issued 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. This followed previous warning letters raising safety concerns about endoscope reprocessing.
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