Olympus Scope Lawsuit [2026 Update]

Olympus Scope Lawsuit Overview: Life-Threatening Infections

Olympus scope lawsuits allege that certain reusable Olympus Medical Devices exposed patients to bacteria after endoscopic procedures.

Claims involve contaminated Olympus endoscopes and related medical instruments that allegedly retained biological material in hard-to-clean areas after reprocessing.

Federal regulators have acknowledged that some duodenoscope contamination risks remained even when a hospital or healthcare provider followed the manufacturer’s cleaning instructions.

The reported injuries include bacterial infections caused by drug resistant organisms, including cases that led to sepsis, repeat hospitalization, and infections requiring IV antibiotics.

In 2018, Olympus pleaded guilty to federal charges for failing to report adverse events involving duodenoscope infections and paid an $85 million criminal penalty.

Lawsuits also allege that Olympus failed to warn health officials and the public about known infection risks associated with these devices.

Recent regulatory actions add detail to those allegations:

• In January 2025, the FDA classified the MAJ-891 forceps and irrigation plug action as a Class I recall, the agency’s most serious recall category, after linking the problem to 120 injuries and one death.
• In June 2025, the FDA announced import alerts affecting certain Olympus devices manufactured in Japan.
• Trade reporting stated that the import action blocked 58 Olympus device models from future importation into the United States.
• Lawsuits cite these events as part of alleged ongoing failures in reporting, warnings, and safety controls involving reusable Olympus scope systems.

Olympus duodenoscope litigation is tied to infection transmission during procedures that patients underwent for diagnosis or treatment.

The allegations focus on whether medical device manufacturers sold reusable scope systems that could not be reliably reprocessed under real clinical conditions.

Those claims involve duodenoscopes, related accessories, and other Olympus products used in invasive procedures.

Patients who developed serious infections after exposure to these devices may seek to pursue compensation for medical treatment, lost income, and other procedure-related losses.

What Are Olympus Scopes and How Are They Used in Medical Procedures?

Olympus scopes are flexible endoscopic medical instruments developed through Olympus Endoscopy, a division of the medical device company Olympus Corporation.

These devices allow physicians to view and treat internal areas of the body without open surgery by inserting a thin, camera-equipped tube through natural openings or small incisions.

Olympus produces a wide range of scopes used across specialties, including gastrointestinal, pulmonary, urological, and surgical procedures.

Among the most widely discussed in litigation are duodenoscopes, which are used during ERCP procedures to diagnose and treat conditions affecting the bile ducts and pancreas.

These procedures often involve navigating narrow anatomical pathways, which requires devices with intricate internal components and moving parts.

Olympus scopes are used in hospitals and outpatient settings as standard tools for diagnosing disease, removing blockages, taking biopsies, and guiding minimally invasive treatment.

Common procedures involving Olympus scopes include:

• Endoscopic Retrograde Cholangiopancreatography (ERCP) using duodenoscopes
• Colonoscopy and upper endoscopy procedures
• Bronchoscopy to examine the lungs and airways
• Cystoscopy and ureteroscopy for urinary tract evaluation
• Laparoscopic procedures using scope-guided surgical visualization

Why These Devices Require Reprocessing Between Patients

Reusable endoscopic devices must undergo cleaning and disinfection between each use to reduce the risk of infection and protect patient safety.

These steps include manual cleaning, high-level disinfection, drying, and storage, often supported by automated endoscope reprocessors designed to standardize parts of the process.

The effectiveness of reprocessing depends on strict adherence to proper procedures and the ability to access all internal surfaces of the device.

Olympus duodenoscopes present a known challenge because their design includes an elevator channel that is difficult to fully clean.

The geometry of this channel contains microscopic gaps and moving parts that can trap biological material and bacteria, allowing biofilms to develop and resist standard cleaning methods.

Studies and regulatory findings have shown that complete sterilization may not be achieved in some cases, even when cleaning protocols are followed correctly.

In response, regulators have required more detailed reprocessing manuals, enhanced inspection protocols, and additional safeguards to address persistent contamination risks associated with these devices.

Olympus Scopes Linked to Infection Risk

Olympus scopes have been repeatedly associated with infection events involving patients exposed to a contaminated device during endoscopic procedures.

Internal investigations and clinical findings have identified outbreaks tied to design limitations in duodenoscopes, particularly involving antibiotic resistant infections such as carbapenem-resistant Enterobacteriaceae (CRE).

These infections are difficult to treat and have been linked to severe complications, including sepsis and organ failure, in patients who underwent otherwise routine procedures.

Between 2013 and 2024, contaminated Olympus duodenoscopes were connected to infections in hundreds of patients across the United States, with reports attributing at least 35 deaths to drug-resistant bacteria.

Hospitals involved in these outbreaks faced reputational harm, regulatory scrutiny, and, in some cases, significant legal settlements tied to patient exposure.

Clinical testing has also identified positive bacterial cultures in reprocessed scopes, including findings showing contamination rates of approximately 4.1% with high-concern organisms.

In response to infection concerns, Olympus issued an urgent field safety notice addressing risks associated with scope components and reprocessing limitations.

Infections linked to Olympus scopes can manifest as severe symptoms, including fever, chills, and abdominal pain, often developing within days or weeks after the procedure.

Types of Bacterial Infections Linked to Contaminated Scopes

Procedures involving Olympus scopes have been linked to several serious bacterial infections, especially when bacteria remain on a scope after reprocessing.

FDA and CDC materials on duodenoscopes describe how complex parts can make these devices harder to fully clean, which helps explain why contamination has remained a concern even after disinfection steps.

Olympus Scopes have been linked to infections involving CRE (carbapenem-resistant Enterobacteriaceae), a group of antibiotic-resistant bacteria that can lead to sepsis, organ failure, or other life-threatening complications.

Reports and outbreak investigations have also identified E. coli, Klebsiella, and Pseudomonas in connection with contaminated endoscopes, and a multicenter study found high-concern organisms on 4.1% of sampled Olympus duodenoscopes after reprocessing.

Unlike ordinary bacterial infections, these infections can become more serious more quickly and leave injured patients facing longer hospital stays, stronger antibiotics, and a more difficult recovery.

Severe Complications Following Infection

A bacterial infection after a scope procedure can move quickly from localized illness to a medical emergency.

Sepsis is the body’s extreme response to an infection and can rapidly lead to tissue damage, organ failure, and death without prompt treatment.

Bloodstream infections can also spread bacteria through the body, which is one reason many patients need hospitalization, IV antibiotics, repeat testing, and close monitoring after exposure to contaminated medical devices.

Severe infection may also trigger septic shock, a condition marked by dangerously low blood pressure and reduced blood flow to vital organs such as the kidneys, lungs, heart, and brain.

These complications help explain why Olympus scope claims often involve long recoveries, intensive care, or death rather than a short course of treatment.

Severe complications linked to infection can include:

• Sepsis: A life-threatening reaction to infection that can cause tissue damage, organ failure, and death.
• Bloodstream infection: Bacteria enter the blood and spread through the body, increasing the risk of systemic illness and rapid decline.
• Septic shock: An advanced form of sepsis involving dangerously low blood pressure and reduced blood flow to vital organs.
• Organ failure: Severe infection can damage the kidneys, lungs, liver, heart, or brain.
• Acute respiratory distress syndrome (ARDS): A serious lung condition that reduces oxygen in the blood and can develop during severe infection or sepsis.
• Disseminated intravascular coagulation (DIC): Abnormal clotting throughout the bloodstream that can block blood flow, damage organs, and later cause severe bleeding.
• Permanent organ damage: Some patients survive sepsis but are left with lasting kidney or other organ injury.
• Death: Overwhelming infection may become fatal, especially once sepsis or septic shock develops.

Hospitalization and Long-Term Health Consequences

Treatment for a serious infection after an Olympus scope procedure often starts in the hospital because these cases can worsen quickly and may involve sepsis, bloodstream infection, or respiratory failure.

Patients with sepsis often need ICU care, where clinicians can monitor blood pressure, breathing, oxygen levels, kidney function, and circulation while trying to stabilize the infection and prevent organ damage.

Early treatment usually includes intravenous fluids and broad-spectrum antibiotics, followed by culture-guided changes once doctors identify the specific bacteria involved.

Some patients require prolonged antibiotic treatment, especially when the infection involves resistant organisms, spreads into the bloodstream, or proves difficult to clear after the initial hospital stay.

Treatment may also require source control, which can include draining infected fluid, removing infected tissue, or addressing the underlying site of infection so antibiotics have a better chance of working.

Recovery does not always end when the infection is gone, because many patients face secondary complications such as acute respiratory distress syndrome, kidney injury, clotting problems, weakness, fatigue, memory problems, or longer-term post-sepsis symptoms that can last for months or years.

Some patients also need ventilator support, rehabilitation, follow-up imaging or lab work, and extended medical care after discharge because severe infection can leave lasting damage even after the bacteria have been treated.

Documented Contamination Rates in Scientific Studies

Scientific studies on reprocessed duodenoscopes found that contamination was still being detected after cleaning and disinfection, including in non-outbreak hospital settings.

The results showed that the problem was not limited to one hospital, one cleaning team, or one isolated infection cluster.

Researchers also found that contamination involved both high-concern organisms linked to disease and lower-concern organisms that still indicated incomplete reprocessing.

Federal surveillance work reached the same general conclusion and identified contamination levels that were higher than regulators had expected.

Published review data went further and showed that contamination persisted across multiple studies even after updated cleaning methods were introduced.

These findings gave regulators and hospitals measurable evidence that reusable duodenoscopes could remain contaminated after reprocessing.

Study findings include:

• 4.1% of Olympus duodenoscopes tested positive for at least one high-concern organism in a prospective multicenter study of reprocessed devices used in non-outbreak settings.
• 15.25% was the pooled contamination rate for reprocessed patient-ready duodenoscopes in a systematic review and meta-analysis of published studies.
• 21.50% was the contamination rate in non-outbreak-initiated studies within that same meta-analysis, showing that positive cultures were not limited to hospitals already dealing with a known outbreak.
• FDA said interim postmarket surveillance data showed higher-than-expected contamination rates after duodenoscope reprocessing and later pushed for contamination-rate disclosures in labeling.

Olympus Recalls and Safety Alerts

Olympus has been the subject of multiple FDA safety actions involving endoscopes and related accessories used in invasive procedures.

These actions include recalls tied to infection risk, device failure, and manufacturing issues affecting patient safety.

Several of the affected products were used repeatedly between patients, which increased the consequences of contamination or mechanical defects.

The FDA has also taken enforcement action against Olympus based on findings of violations of quality system regulations at manufacturing facilities.

Earlier regulatory scrutiny involved devices such as the TJF Q180V duodenoscope, which was associated with infection reporting failures and reprocessing concerns.

These regulatory actions required changes in how certain devices were used, cleaned, distributed, or removed from clinical settings.

Olympus recalls and safety alerts include:

• December 2024 / January 2025: The FDA posted a Class I recall for the MAJ-891 Forceps/Irrigation Plug, linked to the risk of transferring biomaterial between uses, with reports of 120 injuries and one death.
• January 2025: Olympus issued a voluntary recall for an endoscope accessory due to infection risk involving retained biological material after reprocessing.
• June 24, 2025: The FDA issued import alerts for certain Olympus devices manufactured in Japan, citing ongoing violations of quality system regulations, with reporting indicating 58 affected models.
• September 30, 2025: The FDA issued a Class I recall for certain ViziShot 2 FLEX endoscopic aspiration needles due to a design defect linked to patient injury and at least one reported death.

FDA actions required hospitals and medical professionals to stop using certain devices, follow updated instructions, or transition to alternative products.

These events remain part of the regulatory history cited in Olympus scope litigation.

Olympus Devices Involved in Infection Lawsuits

Olympus infection lawsuits focus first on duodenoscopes used in ERCP procedures, because those devices were repeatedly tied to contamination concerns, FDA action, and infection-reporting failures.

The TJF-Q180V duodenoscope appears most often in the public regulatory record, alongside older Olympus ERCP models that FDA placed under postmarket surveillance in 2015.

Olympus safety actions also involve other reusable scope categories and accessories used in pulmonary, urological, gynecological, and surgical procedures.

The FDA’s June 24, 2025 import-alert letter identified specific Olympus bronchoscopes, ureterorenoscopes, laparoscopes, and automated endoscope reprocessors manufactured in Japan.

The MAJ-891 recall involved an accessory used with compatible cystoscope, ureteroscope, choledochoscope, and hysteroscope lines.

Specific Olympus devices and product lines involved in infection lawsuits or related safety actions include:

• TJF-Q180V duodenoscope: the Olympus model most closely associated with the federal infection-reporting case and FDA surveillance orders.
• JF-140F duodenoscope: one of the Olympus ERCP models included in FDA’s 2015 postmarket surveillance order.
• PJF-160 duodenoscope: another Olympus ERCP model placed under FDA surveillance because infection could result in serious adverse health consequences.
• TJF-160F duodenoscope: included in the same FDA order covering Olympus ERCP scope models.
• TJF-160VF duodenoscope: also named in FDA’s 2015 postmarket surveillance order.
• MAJ-891 Forceps/Irrigation Plug: a reusable accessory attached to certain Olympus scopes, including CYF, URF, CHF, and HYF series devices.
• Certain Olympus bronchoscopes, ureterorenoscopes, laparoscopes, and automated endoscope reprocessors: device categories identified in FDA’s June 24, 2025 import-alert action.

Olympus scope litigation includes both devices used directly during procedures and accessories or reprocessing systems tied to contamination control.

Duodenoscope claims remain the main body of the infection cases. Later safety actions expanded the device list beyond ERCP products alone.

Do You Qualify for an Olympus Scope Infection Lawsuit?

You may qualify to file a lawsuit if you underwent an endoscopy or colonoscopy involving an Olympus scope in 2015 or later and developed a serious infection shortly after the procedure.

TorHoerman Law is reviewing cases where patients were diagnosed with sepsis, a superbug infection such as CRE, or another severe bacterial illness that required hospitalization within 30 days of the scope.

In rare cases, claims may also involve HIV or tuberculosis exposure, although those conditions do not typically appear within that same time window.

Timing matters in these cases.

The infection must follow the procedure closely enough to raise concern that a contaminated scope or accessory may have been involved.

Medical records showing the procedure date, onset of symptoms, diagnosis, and hospitalization are critical when evaluating Olympus duodenoscope lawsuits and related claims.

Certain prior medical conditions can affect eligibility.

Cases are generally not accepted if the patient had dialysis, chemotherapy, recent surgery, existing infections, implants, or procedures involving orthoscopes, ureteroscopes, or cystoscopes in the 30 days before the scope, because those factors can introduce alternative sources of infection.

If your situation meets these criteria, TorHoerman Law may be able to provide legal representation and evaluate whether you have grounds to pursue a claim tied to a contaminated Olympus scope procedure.

Evidence in Olympus Scope Infection Cases

Evidence in Olympus scope cases focuses on connecting the procedure, the device used, and the onset of infection within a defined timeframe.

These claims often require a detailed review of hospital records to determine whether a contaminated scope may have been involved.

Unlike simpler injury claims, medical device litigation involving infection requires proof of both exposure and resulting harm.

Documentation must show when the procedure occurred, what device was used, and how the infection developed afterward.

Evidence in Olympus scope infection cases may include:

• Medical records identifying the type of scope used (e.g., duodenoscope, endoscope, colonoscope)
• Hospital records showing admission, diagnosis, and treatment for infection
• Laboratory results confirming bacterial infection (e.g., CRE, E. coli, Klebsiella, Pseudomonas)
• Timing records establishing infection onset within 30 days of the procedure
• Discharge summaries and physician notes documenting complications such as sepsis or organ failure
• Infection control or exposure notification letters from the hospital
• Device tracking logs or internal hospital reports identifying potentially contaminated equipment
• Billing records and treatment history showing ICU care, IV antibiotics, or extended hospitalization

Potential Compensation in the Olympus Scopes Case

Compensation in Olympus scope cases is based on the specific harm a patient experienced after the procedure, not a fixed payout amount.

In mass tort litigation, attorneys evaluate damages by reviewing medical records, treatment history, and the long-term impact of the infection on a patient’s health and daily life.

That process often includes calculating past and future medical expenses, lost income, and the extent of physical and emotional suffering tied to the infection.

Lawyers also compare similar infection-related cases and outcomes to build a claim that reflects the severity of the injury and the evidence available.

Potential compensation in an Olympus scope lawsuit may include:

• Medical expenses, including hospitalization, ICU care, surgeries, and follow-up treatment
• Costs of prolonged antibiotic therapy and ongoing medical monitoring
• Lost wages and reduced earning capacity due to time away from work or lasting health issues
• Pain and suffering related to infection, complications, and recovery
• Long-term or permanent disability caused by organ damage or severe infection
• Rehabilitation, home care, or assistive medical services
• Wrongful death damages for families who lost a loved one after infection complications

TorHoerman Law: Investigating Olympus Lawsuit Claims

Olympus scope infection cases require a careful review of medical records, procedure history, and the timing and severity of the infection.

TorHoerman Law examines whether a contaminated device may have been involved, along with the regulatory history and known risks tied to Olympus products.

These claims often involve detailed evidence and medical documentation, which is why early evaluation can make a difference in preserving records and identifying the source of infection.

If you or a family member developed a serious infection after an endoscopy or colonoscopy, TorHoerman Law is available to review your case in a free consultation.

Contact the firm to discuss your medical history, the procedure involved, and whether you may have grounds to pursue compensation related to an Olympus scope.