Olympus Scope Lawsuit [2026 Update]

Olympus has received an FDA warning letter following inspections of six of its manufacturing facilities, according to a company announcement on October 13, 2026.

The letter is dated October 7 and stems from inspections carried out in late 2025 at four endoscope production sites in Japan, a manufacturing site in Hamburg, Germany, and a Gyrus ACMI facility in Brooklyn Park, Minnesota.

It primarily concerns Olympus’s quality management systems and related manufacturing processes, though the company has not publicly detailed the specific violations or identified which devices are affected.

Olympus says it has been correcting the problems since the inspections ended and plans to submit a comprehensive response to the FDA within 15 business days of receiving the letter, with periodic updates until the agency finds its corrective actions adequate.

The company also says the warning does not require a recall or restrict manufacturing, marketing or distribution, and that customers do not need to take additional action.

CEO Bob White said Olympus takes the concerns “seriously” and is “fully committed to resolving these matters.”

The letter adds to a long regulatory history for the company’s endoscopes.

The FDA first warned in 2015 that duodenoscopes have hard to clean areas where contamination can persist, and in 2018 Olympus pleaded guilty to failing to report serious duodenoscope related infections to the agency, agreeing to pay $85 million.

The FDA sent another warning letter to an Olympus facility in Japan in 2022 over quality control deficiencies involving endoscopes and reprocessing equipment, and in June 2025 it restricted imports of certain Japan made Olympus endoscopes and automated reprocessing equipment over unresolved quality control violations.

Individual lawsuits over Olympus scopes are continuing. Plaintiffs allege design defects and contamination risks that can allow bacteria to spread between patients, leading to serious infections, sepsis, organ failure and death.

A Kentucky man has filed a wrongful death lawsuit claiming his wife died of septic shock and organ failure caused by an Olympus endoscope infection.

The complaint was brought by the plaintiff on behalf of himself and his late wife in the Philadelphia Court of Common Pleas in May.

It names Olympus Medical Systems Corporation and its U.S. subsidiaries as defendants, and was removed to the U.S. District Court for the Eastern District of Pennsylvania on August 28.

The plaintiff’s wife underwent an ERCP in May 2025 using an Olympus TJF-Q190V duodenoscope.

She began experiencing severe abdominal pain that evening and was diagnosed with sepsis.

Within 36 hours, she was in septic shock and multisystem organ failure.

Cultures identified Klebsiella pneumoniae as the source, a bacteria also linked to a 2015 endoscope-related outbreak in the Netherlands.

The plaintiff’s wife underwent seven major abdominal surgeries between July 2025 and her death on November 15, 2025.

The lawsuit alleges the endoscope’s design, including deep grooves and moving parts, allowed infectious material to remain hidden during sterilization.

The case is based on claims of negligence, failure to warn, design defect, manufacturing defect, breach of warranty and wrongful death. The plaintiff seeks compensatory and punitive damages.

A federal judge will meet with attorneys for Olympus Corporation and a Chicago woman who alleges a defectively designed colonoscope caused her to develop a serious infection. 

She brought the lawsuit in the U.S. District Court for the Northern District of Illinois on July 9, naming Olympus and several subsidiaries as defendants. 

She alleges a non-sterile Olympus CF-HQ190L colonoscope used during an August 2024 procedure caused her to develop a C. diff infection that led to permanent injuries.

An initial status hearing is scheduled for September 29, with a joint status report due by September 22. 

The judge ordered all served defendants to participate regardless of whether they’ve formally responded to the complaint. 

The suit brings claims including defective design, failure to warn, manufacturing defect, and fraudulent concealment, seeking both compensatory and punitive damages.

The case follows years of scrutiny over endoscope sterilization difficulties, including a 2014-2015 outbreak of antibiotic-resistant infections tied to duodenoscope design flaws and a 2018 FDA warning over inadequate post-market surveillance of these devices. 

Several similar Olympus colonoscopy lawsuits have been filed nationwide, each alleging the company’s scopes remain difficult to fully sterilize between procedures.

A Texas woman has filed a product liability lawsuit against Fujifilm, alleging she suffered hearing damage when part of one of its endoscopes exploded during an equipment demonstration.

The complaint was filed in Texas state court for Dallas County in June, naming Fujifilm Healthcare Americans Corp. and Fujifilm employee Jeremy Roper as defendants, and was then removed to federal court late last month.

Unlike the infection-related claims currently being pursued against Olympus over its reusable duodenoscopes, the plaintiff’s case does not involve contamination or bacterial exposure.

It instead centers on an alleged equipment malfunction during a training demonstration.

The plaintiff alleges that in March, while she was working at Texas Health Presbyterian Hospital-Plano, Roper connected a sterile water bottle to a carbon-dioxide insufflator as part of a demonstration on new Fujifilm endoscope equipment.

She claims he clamped the tubing, preventing the bottle from venting excess pressure, causing it to burst.

The plaintiff was wearing hearing aids at the time, which she alleges amplified the sound of the explosion and caused severe hearing damage.

Fujifilm has denied responsibility for the incident.

A Chicago woman filed a new product liability lawsuit against Olympus in the U.S. District Court for the Northern District of Illinois, joining other product liability lawsuits involving reusable Olympus endoscopes.

The plaintiff alleges that a colonoscope used during her August 2024 procedure left her with a C. diff infection due to design flaws that allegedly prevented the device from being fully sterilized using Olympus’s recommended reprocessing procedures.

The plaintiff says she developed liquid diarrhea, severe cramping, and rectal bleeding within weeks of her colonoscopy, leading to a 10-day hospitalization and treatment with vancomycin and later fidaxomicin. 

She was diagnosed with C. diff a second time that October and claims she continues to suffer recurring infections and a lasting fear of future endoscopic procedures.

The complaint leans heavily on an FDA-ordered human-factors study, which found healthcare workers repeatedly failed to complete critical reprocessing steps using Olympus’s instructions. 

The complaint also cites an FDA-required postmarket study in which only 34.8% of sampled reprocessed endoscopes were free of contamination.

The plaintiff asserts claims for defective design, manufacturing defect, failure to warn, negligence, breach of warranty, fraud, and related causes of action, seeking compensatory and punitive damages.

Federal regulators continue to scrutinize reusable Olympus endoscopes as concerns persist about their design.

Certain device designs may allow bacteria and other biological material to remain inside the scopes even after recommended cleaning and high-level disinfection.

The FDA has warned for years that the complex construction of some reusable duodenoscopes can make them difficult to fully reprocess.

According to the agency, this can increase the risk of patient-to-patient transmission of serious infections even when hospitals follow the manufacturer’s reprocessing instructions.

Those concerns have remained in focus as the FDA issued import alerts in 2025 affecting dozens of Olympus medical devices manufactured at facilities in Japan after identifying quality system violations.

The agency also continues to encourage manufacturers to transition toward designs with disposable or removable components that reduce contamination risks associated with reusable scopes.

Independent studies have likewise found that some reprocessed duodenoscopes continue to show bacterial contamination, supporting ongoing efforts to improve device design and infection prevention practices.

A newly filed wrongful death lawsuit is drawing renewed attention to ongoing concerns surrounding reusable Olympus duodenoscopes and the risk of device-related infections.

The complaint, filed in federal court in Washington on June 5, alleges that a patient developed a fatal vancomycin-resistant Enterococcus (VRE) infection after undergoing an ERCP procedure with an Olympus TJF-Q190V duodenoscope.

According to the lawsuit, the patient showed no evidence of VRE infection before the procedure but developed severe complications in the days that followed, ultimately dying from septic shock and organ failure.

The complaint claims the infection was introduced through the duodenoscope and alleges Olympus failed to adequately address known contamination risks associated with reusable endoscopes.

The lawsuit points to years of research and regulatory scrutiny surrounding duodenoscope contamination, including concerns that complex device components can harbor bacteria even after recommended cleaning and disinfection procedures are followed.

It also references post-market surveillance findings that identified contamination in a significant percentage of reprocessed endoscopes, raising ongoing questions about whether current reprocessing methods are sufficient to eliminate infection risks.

While the allegations have not been proven in court, the case highlights a central issue in the Olympus scope litigation: whether reusable endoscopes can retain dangerous bacteria despite complying with the manufacturer’s cleaning instructions.

Plaintiffs nationwide continue to argue that contamination risks, including exposure to drug-resistant organisms and severe infections, were not adequately addressed or disclosed, while Olympus has maintained that its devices are safe when properly used and reprocessed.

A new study published online in Gut on June 3, 2026, examined the environmental impact of single-use and reusable duodenoscopes used during ERCP procedures, but the research also underscores why contamination concerns surrounding reusable scopes remain a significant issue for patients and healthcare providers.

Researchers compared disposable and reusable duodenoscope systems and noted that concerns about duodenoscope-associated contamination and infection continue to drive interest in single-use devices.

While the study primarily focused on sustainability, the authors acknowledged that previous research has identified persistent contamination in reusable duodenoscopes even after they have undergone standard reprocessing procedures.

The study does not prove that any patients developed infections as a result of contamination, nor did it evaluate clinical outcomes.

However, the authors specifically referenced existing evidence showing that contamination can remain present in “patient-ready” duodenoscopes despite cleaning and disinfection efforts.

Those contamination concerns remain at the center of ongoing Olympus scope infection litigation, where plaintiffs allege that certain reusable duodenoscope designs were difficult to adequately disinfect, allowing bacteria to persist inside the devices and potentially expose patients to harmful infections.

Although contamination alone does not establish that an infection occurred, any level of residual contamination is a potential concern because it may create an opportunity for bacteria to be transmitted between patients during subsequent procedures.

The study ultimately concluded that reusable duodenoscopes had a lower environmental footprint than disposable alternatives under the conditions examined, but researchers noted that single-use devices may still be appropriate in certain infection-control situations where contamination risks are a heightened concern.

A new study is adding to the growing discussion over how hospitals can reduce the infection risks historically linked to reusable duodenoscopes during ERCP procedures.

Researchers from the Indiana University School of Medicine reported a 94% technical success rate for single-use duodenoscopes across 267 procedures performed between 2020 and 2023 at a high-volume tertiary care center.

The study found that use of disposable scopes gradually increased over the three-year period, rising from 2.6% of ERCP procedures in 2020 to 4.7% in 2023.

Researchers noted that the devices were most commonly used in patients considered at higher risk of infection complications, including immunocompromised individuals and those at risk of harboring drug-resistant organisms.

Investigators reported that technical failures requiring a switch to reusable duodenoscopes occurred in about 6% of cases, with the most common issues involving poor visualization and maneuverability.

However, the study found that newer versions of the disposable scopes showed improvements in image stability, scope stiffness, and elevator functionality over time.

The findings come as Olympus and other endoscope manufacturers continue to face scrutiny and litigation over contamination risks associated with reusable duodenoscopes.

Federal regulators and researchers have increasingly focused on whether single-use devices may help reduce the transmission of dangerous bacteria linked to prior outbreaks and patient infections.

The findings come as Olympus and other endoscope manufacturers continue to face scrutiny and litigation over contamination risks associated with reusable duodenoscopes.

Federal regulators and researchers have increasingly focused on whether single-use devices may help reduce the transmission of dangerous bacteria that has been linked to prior outbreaks and patient infections.

New research is adding to growing concerns about infection risks associated with reusable Olympus scopes and other gastrointestinal endoscopes used in colonoscopy and ERCP procedures.

Studies now suggest that nearly 1 in 5 reprocessed endoscopes may still carry harmful bacteria even after hospitals follow manufacturer cleaning and disinfection instructions.

Researchers reviewing contamination data found that colonoscopy scopes showed the highest contamination rates, with bacteria detected in nearly one-third of devices tested.

Upper endoscopy scopes also showed significant contamination levels, while duodenoscopes used in ERCP procedures continued to raise concerns over persistent bacterial transmission and “superbug” outbreaks.

The findings are particularly concerning because reusable endoscopes contain narrow internal channels and complex components that may be difficult to fully disinfect.

Prior FDA investigations into Olympus duodenoscopes have already linked contaminated devices to outbreaks involving carbapenem-resistant Enterobacteriaceae (CRE), E. coli, bloodstream infections, sepsis, and other serious complications.

Some outbreaks occurred even when healthcare facilities reported following approved reprocessing procedures.

As a result, attorneys nationwide continue investigating Olympus scope infection lawsuits on behalf of patients who developed severe infections after colonoscopy, ERCP, bronchoscopy, and related procedures.

Lawsuits are expected to allege that certain reusable endoscopes were defectively designed, allowing bacteria to remain trapped inside the devices and creating ongoing risks of cross-contamination between patients.

Researchers and regulators continue to push for improved sterilization protocols, enhanced surveillance testing, and broader adoption of disposable or redesigned scopes to reduce infection risks associated with reusable endoscopic devices.

A new analysis of the FDA’s MAUDE database is raising additional concerns about the safety and reliability of endoscopic ultrasound (EUS) devices, including Olympus scope systems frequently used in gastrointestinal procedures.

Researchers reviewed more than 7,600 adverse event reports tied to EUS devices between 2000 and 2025, identifying thousands of device failures and patient complications.

The study found that peeling or delaminating scope components, device breakage, microbial contamination, and inadequate cleaning were among the most commonly reported device problems.

Investigators also documented hundreds of contamination reports involving bacteria such as Pseudomonas aeruginosa and coagulase-negative staphylococci, organisms that can survive inside damaged or difficult-to-clean endoscopes.

Researchers noted that reports involving EUS devices increased sharply between 2020 and 2023, with Olympus devices accounting for the majority of reports in the database.

The authors warned that structural damage and contamination issues may contribute to infection risks even when standard cleaning protocols are followed, echoing concerns raised in prior Olympus duodenoscope litigation and FDA safety alerts.

A newly published study is raising fresh concerns about whether current duodenoscope testing methods can reliably detect dangerous contamination linked to reusable endoscopes, including Olympus scopes used during ERCP procedures.

Researchers analyzed more than seven years of duodenoscope surveillance data from a major hospital in the Netherlands, reviewing 556 duodenoscope cultures and more than 5,200 ERCP procedures.

The study found that up to 23.7% of procedures may have involved contaminated duodenoscopes carrying microorganisms of gut or oral origin.

Investigators also found that current culture testing methods may miss contamination at concerning rates.

According to the study, the sensitivity of duodenoscope cultures may be as low as 82.2%, meaning contaminated scopes could potentially test negative and be cleared for continued patient use.

The researchers identified repeated contamination involving genetically related bacteria across multiple scopes, including clusters of Pseudomonas aeruginosa contamination that persisted over long periods.

Some contaminated duodenoscopes continued to be used on patients between testing intervals because hospitals generally rely on a single negative culture result before returning devices to service.

The study warned that biofilm buildup inside reusable endoscope channels may shield bacteria from detection during cleaning and sampling, potentially contributing to false-negative test results and prolonged contamination.

Researchers concluded that the current practice of relying on a single negative culture to clear quarantined duodenoscopes for reuse “should be re-evaluated,” adding to ongoing concerns about Olympus scope infections, endoscope reprocessing failures, and the risk of undetected bacterial transmission associated with reusable duodenoscopes.

A newly published study is raising fresh concerns about the ability of hospitals to detect dangerous endoscope contamination, after researchers identified a prolonged “silent” transmission of Pseudomonas aeruginosa linked to contaminated duodenoscopes at a French hospital.

According to the study, eight patients developed infections or colonization after undergoing ERCP procedures with a contaminated duodenoscope between 2021 and 2022, despite the device repeatedly passing routine microbiological testing earlier in the outbreak.

Researchers later discovered persistent contamination in two separate duodenoscopes, with whole genome sequencing confirming that all patient infections were part of the same clonal bacterial cluster.

The authors warned that the outbreak went undetected for months, even though the hospital followed standard cleaning and reprocessing procedures.

Researchers also noted that some patients developed infections outside the biliary tract, suggesting transmission routes that are often overlooked in investigations.

The study concluded that current testing and reprocessing methods may fail to detect ongoing contamination in reusable duodenoscopes, particularly when the bacteria involved are not multidrug-resistant.

Researchers called for enhanced surveillance strategies, improved endoscope designs, and broader post-procedure monitoring to help prevent future infections tied to contaminated scopes.

Olympus has issued a new global corrective action involving certain bronchoscopes used during airway procedures, following additional reports of endobronchial combustion linked to the devices.

The updated safety communication expands on a prior 2023 warning that was issued after reports of severe patient injuries and one death.

According to Olympus, investigations conducted after the original corrective action revealed the need for additional instructions involving the use of bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment.

Since 2023, the company says it has received four additional reports of serious injuries, including one in the United States.

The company now recommends several additional precautions during procedures, including maintaining more than 4 centimeters of separation between the endoscope and endotracheal tube, keeping oxygen concentrations below 40%, limiting energy output to less than 40 watts, avoiding prolonged energy application at a single location, and using suction to evacuate smoke.

Olympus warned that failure to follow the updated instructions could result in combustion inside the airway, potentially causing severe burns to the lungs or airways, prolonged hospitalization, ICU admission, surgical intervention, or death.

The company also noted that device components damaged during combustion could break apart and remain inside the patient.

The latest corrective action adds to the ongoing scrutiny surrounding Olympus endoscopes and bronchoscopes, which have been linked to prior recalls, outbreaks of infections, contamination concerns, and multiple FDA warning letters regarding quality control and patient safety issues.

A new October 2025 commentary continues concerns about deadly infections linked to contaminated endoscopes and duodenoscopes, arguing that hospitals are still failing to detect many outbreaks until patients are seriously harmed.

The article points to the case of California patient Aaron Young, who developed a severe antibiotic-resistant infection after undergoing a routine procedure involving a contaminated duodenoscope.

His case was part of the broader wave of endoscope-related outbreaks that led to a 2016 Senate investigation, which found that more than 250 drug-resistant infections and multiple deaths were linked to contaminated scopes used in hospitals nationwide.

According to the commentary, many hospitals still rely on outdated infection-detection methods that treat cases as isolated incidents rather than identifying broader transmission patterns.

Researchers at the University of Pittsburgh Medical Center (UPMC) say they have implemented a genomic surveillance system known as EDS-HAT, which analyzes bacterial DNA in real time to identify potential outbreaks before they spread.

The researchers report that the system has already helped detect and stop multiple hospital outbreaks, including endoscope-related infections that may otherwise have gone unnoticed.

The article argues that broader adoption of genomic surveillance could help hospitals identify contaminated devices more quickly, reduce healthcare-associated infections, and prevent future outbreaks linked to reusable endoscopes and other medical equipment.

The update adds to continuing scrutiny surrounding duodenoscope safety, sterilization practices, and whether current high-level disinfection protocols are sufficient to prevent the spread of dangerous multidrug-resistant bacteria in healthcare settings.

Olympus has issued an urgent field corrective action for its TJF-Q190V duodenoscope, warning healthcare providers about updated reprocessing and inspection procedures in response to ongoing concerns about infection risks associated with the device.

According to the October 14, 2025, customer notice, Olympus identified changes to its cleaning and reprocessing instructions after continued assessments involving positive cultures and infection reports linked to the duodenoscope systems.

The company acknowledged that improper or incomplete reprocessing could expose patients to contaminated devices, potentially resulting in serious or life-threatening infections.

Olympus stated that from 2024 to the present, it received reports of two deaths and five serious injuries potentially associated with infections or contamination linked to duodenoscopes, although the company said there was insufficient information to definitively determine causation.

As part of the corrective action, Olympus updated its reprocessing training materials, added enhanced visual inspection guidance, and now recommends using 10x magnification tools to inspect the distal ends of the scopes for damage or irregularities before use.

The company is also requiring facilities to complete updated training modules and review revised operating and reprocessing manuals.

The notice adds to years of ongoing scrutiny involving Olympus duodenoscopes and broader concerns about whether current endoscope cleaning and high-level disinfection protocols are sufficient to prevent contamination and dangerous patient infections.

Olympus has issued another major medical device recall involving its endoscope products, this time affecting certain ViziShot 2 FLEX endoscopic needles after reports that device components could detach during procedures and enter a patient’s airway.

According to a recent FDA safety notice, the recall involves Olympus ViziShot 2 FLEX (19G) EBUS-TBNA needles manufactured before May 12, 2025.

The specialized needles are commonly used during endoscopic procedures to collect tissue samples from the lungs and surrounding airways, often to help diagnose cancer or other abnormalities.

Federal regulators warn that if the device sheath becomes damaged during use, internal components such as the hypotube and plastic pieces may separate and eject into the patient’s airway.

The FDA indicates Olympus has already received multiple adverse event reports linked to the issue, including several injuries and at least one patient death.

Olympus has since updated its manufacturing process, replacing prior visual inspections with an automated inspection system intended to better identify defects during assembly.

The company has also instructed healthcare providers to quarantine and return affected devices immediately.

The recall adds to growing scrutiny surrounding Olympus endoscope products and device safety concerns over the last several years.

Earlier this year, Olympus recalled certain single-use endoscope guide sheath kits after detached tips allegedly caused dozens of patient injuries. In 2024, Olympus also faced warnings tied to bacterial contamination involving endoscope components linked to more than 120 injuries and one reported death.

Federal regulators have repeatedly raised concerns about Olympus quality control practices in recent years.

In 2023, the FDA issued warning letters regarding unresolved duodenoscope contamination issues and failures involving bronchoscope equipment that had reportedly caught fire during procedures.

The latest recall is expected to add to ongoing concerns surrounding reusable and specialized endoscope systems, particularly as hospitals and regulators continue debating whether current cleaning, inspection, and sterilization protocols are sufficient to prevent device-related injuries and infections.

A new multisociety guidance document published in Infection Control & Hospital Epidemiology aims to clarify longstanding questions about endoscope sterilization, high-level disinfection (HLD), and infection prevention practices for reusable medical devices.

The guidance was developed by the Society for Healthcare Epidemiology of America (SHEA) in collaboration with several major healthcare organizations, including the American Society for Gastrointestinal Endoscopy (ASGE), the Society of Gastroenterology Nurses and Associates (SGNA), and The Joint Commission.

The recommendations follow the CDC’s 2024 update to its disinfection and sterilization guidelines and address issues ranging from manufacturer instructions for use (IFUs) to storage, drying, microbial surveillance, and alternatives to HLD.

One of the document’s most closely watched sections concerns duodenoscope reprocessing.

Following carbapenem-resistant Enterobacteriaceae outbreaks linked to contaminated duodenoscopes in the mid-2010s, many hospitals adopted enhanced cleaning measures such as double high-level disinfection or sterilization.

However, the new guidance concluded that current evidence does not support requiring double HLD or mandatory sterilization for duodenoscopes when standard reprocessing is properly performed.

Instead, the panel stated that healthcare facilities may evaluate transitioning toward sterilization or consider alternatives such as sterile single-use duodenoscopes.

The guidance emphasized that consistent adherence to manual cleaning, inspection, and standard HLD protocols remains the most important factor in reducing contamination risk.

The recommendations also acknowledge several unresolved issues.

The panel declined to issue formal recommendations on routine microbial culturing, maximum storage times for processed scopes, or the effectiveness of specialized drying cabinets due to limited evidence.

Additional knowledge gaps identified in the appendix include questions about borescopes, lubricating agents, the use of simethicone, and optimal retraining practices for staff responsible for endoscope reprocessing.

Not all experts agreed with the document’s conclusions.

Medical device safety researcher Lawrence Muscarella, PhD, raised concerns about the guidance’s handling of rinse water contamination and its decision not to recommend routine water-quality testing.

Muscarella noted that waterborne organisms, such as Pseudomonas, have previously been linked to true patient infections involving contaminated endoscopes, despite guidance suggesting that some rinse-water contamination events were not clinically significant.

The publication comes as hospitals, regulators, and manufacturers continue facing scrutiny over reusable endoscope contamination risks and the effectiveness of current cleaning protocols.

A recent study published in Gastrointestinal Endoscopy is raising additional concerns about contamination risks tied to reusable duodenoscopes, finding that patients may still be exposed to dangerous bacteria even when hospitals follow microbiological surveillance protocols.

Researchers at Erasmus MC in the Netherlands analyzed more than seven years of duodenoscope surveillance data involving Olympus and Pentax scopes used during ERCP procedures.

The study found that contamination persisted despite routine culturing and reprocessing measures, with investigators estimating that between 12.3% and 23.7% of ERCP procedures may have involved contaminated duodenoscopes.

The paper also questioned the reliability of current surveillance testing methods. Researchers reported that duodenoscope culture sensitivity may be as low as 82.2%, meaning contaminated devices could incorrectly test negative and be returned to clinical use.

In several instances, false-negative cultures allegedly allowed scopes contaminated with microorganisms to remain in circulation and continue to be used on patients.

Investigators identified repeated contamination involving microorganisms of gut or oral origin, including Pseudomonas aeruginosa, Klebsiella pneumoniae, and yeast species.

The study noted that contaminated scopes were sometimes used dozens or even hundreds of times before contamination patterns were fully recognized.

The findings add to growing scrutiny surrounding reusable duodenoscope systems and the effectiveness of current cleaning protocols.

Separate recent research published in the American Journal of Infection Control similarly reported that high-level disinfection frequently failed to eliminate microorganisms from patient-ready endoscopes, including multidrug-resistant organisms and fungi.

As concerns over reusable scope contamination persist, hospitals and manufacturers have increasingly explored disposable or partially disposable duodenoscope designs to reduce the risk of infection transmission.

A separate 2025 study found growing adoption of single-use duodenoscopes at a major U.S. medical center, where physicians reported improved performance with newer disposable models over time.

A newly published review in the American Journal of Infection Control is renewing concerns over infection risks linked to reusable Olympus duodenoscopes and other flexible endoscopes, warning that high-level disinfection (HLD) may not reliably eliminate dangerous bacteria in real-world healthcare settings.

The June 2025 review examined studies, FDA reports, and outbreak investigations published between 2019 and 2024, concluding that contamination of patient-ready endoscopes remains a widespread problem despite adherence to current cleaning standards.

Researchers found that many endoscopes continued to harbor multidrug-resistant organisms, fungi, and other potentially dangerous pathogens even after undergoing high-level disinfection procedures.

According to the review, dozens of outbreaks linked to contaminated endoscopes have been reported in recent years, including infections involving drug-resistant bacteria such as carbapenem-resistant Enterobacteriaceae (CRE), Pseudomonas aeruginosa, and multidrug-resistant E. coli.

Several outbreaks were tied to Olympus scopes and accessories, with some cases resulting in sepsis and death.

The article also highlights FDA findings that many hospitals and clinics failed to fully follow manufacturers’ cleaning instructions, with investigators documenting repeated breaches involving delayed cleaning, improper drying, skipped leak testing, and contaminated storage conditions.

In some cases, patients were notified of potential exposure after hundreds or even thousands of procedures had been performed using improperly reprocessed scopes.

Researchers noted that Olympus duodenoscope surveillance studies have previously found high-concern organisms in approximately 5% of sampled devices, despite the scopes being processed according to the manufacturer’s instructions.

The review warns that the complex design of reusable scopes may make complete disinfection difficult, even when healthcare facilities attempt to comply with current protocols.

The publication adds to growing scrutiny surrounding Olympus scope infection lawsuits, which continue to allege that reusable endoscope systems were defectively designed and carried unreasonable contamination risks.

Federal regulators have increasingly encouraged healthcare providers to transition toward sterilization methods and disposable scope technologies in an effort to reduce patient exposure to dangerous infections.

A recent June 2025 article by infection prevention expert Karen Butler is drawing renewed attention to long-running concerns about Olympus duodenoscopes and other reusable endoscopes, questioning whether high-level disinfection alone is sufficient to protect patients from dangerous infections.

The report revisits the nationwide outbreaks linked to contaminated duodenoscopes over the past decade, including the 2015 superbug outbreaks involving carbapenem-resistant Enterobacteriaceae (CRE), which were tied to improperly reprocessed endoscopes and linked to approximately 250 infections and 25 deaths.

Federal regulators later acknowledged that Olympus duodenoscopes and similar devices could remain contaminated even when hospitals followed manufacturer cleaning instructions correctly.

According to Butler’s review, FDA postmarket surveillance studies found that up to 5.4% of reprocessed duodenoscope samples tested positive for high-concern organisms such as E. coli and Pseudomonas aeruginosa, despite undergoing high-level disinfection procedures.

The article notes that repeated rounds of disinfection did not significantly reduce contamination rates, adding to concerns that the complex design of reusable scopes may make complete sterilization difficult.

The update also highlights a growing shift toward sterilization and disposable scope technologies.

Since 2020, the FDA has repeatedly encouraged healthcare providers to transition toward duodenoscopes with innovative or disposable designs and to consider terminal sterilization methods instead of traditional high-level disinfection whenever feasible.

Those concerns have expanded beyond duodenoscopes.

In 2024, the FDA issued additional safety communications regarding contamination risks involving reprocessed bronchoscopes and urological endoscopes, warning that multidrug-resistant bacteria may still survive standard cleaning procedures.

The renewed focus on scope contamination comes as Olympus continues to face scrutiny over endoscope-related infection risks and recalls.

In recent months, federal regulators announced recalls involving Olympus guide sheath kits after reports that components detached inside patients, while prior FDA alerts linked Olympus endoscope accessories to more than 120 patient injuries and at least one death tied to contamination concerns.

As hospitals increasingly move toward disposable devices and enhanced sterilization protocols, plaintiffs in Olympus scope infection lawsuits continue to argue that manufacturers failed to adequately address known contamination risks associated with reusable endoscope systems.

A newly published medical review is adding to growing concerns surrounding Olympus scope infection lawsuits and other endoscope-related litigation, finding that high-level disinfection procedures frequently fail to eliminate dangerous bacteria and contamination risks from reusable medical scopes.

The study was published in the American Journal of Infection Control in April 2025.

Researchers reviewed infection reports, FDA adverse event data, hospital inspections, and outbreak investigations from 2019 through 2024 involving reusable endoscopes, including Olympus duodenoscopes, bronchoscopes, cystoscopes, and gastrointestinal scopes.

According to the paper, dozens of outbreaks tied to contaminated endoscopes were reported in recent years, including infections involving multidrug-resistant organisms and bacteria linked to sepsis and patient deaths.

The review found that high-level disinfection, commonly referred to as HLD, often failed to reliably eliminate microbial contamination in real-world clinical settings.

Researchers cited studies showing contamination remained on 6% to 72% of patient-ready endoscopes after reprocessing, with some devices testing positive for dangerous pathogens, including Pseudomonas, Klebsiella, fungi, and drug-resistant bacteria.

The paper also highlighted repeated FDA findings involving Olympus devices, including reports of hospitals skipping required cleaning steps, failing leak tests, improperly drying scopes, and continuing to use damaged equipment.

In several outbreak investigations, facilities were forced to notify hundreds or even thousands of patients about potential exposure to contaminated scopes.

Researchers concluded that current endoscope processing methods may be insufficient to fully protect patients, calling for broader adoption of sterilization rather than high-level disinfection alone.

The authors warned that reusable endoscopes continue to pose serious infection risks, particularly when they come into contact with sterile tissue or the bloodstream during procedures.

Federal regulators are warning healthcare providers about serious risks associated with certain Olympus endoscope guide sheath kits after reports that device tips detached from the kits during procedures.

In a recall announcement issued earlier this year, the U.S. Food and Drug Administration said certain single-use Olympus guide sheath kits may separate during insertion or when excessive force is applied.

The detached components can remain inside a patient’s airway or lungs, potentially causing internal bleeding, additional procedures, or other serious complications.

According to the FDA, at least 26 injuries have been linked to the issue so far, though no deaths have been reported.

The recall affects Olympus Single Use Guide Sheath Kits with model numbers K-201, K-202, K-203, and K-204, including sheath models SG-200C and SG-201C.

Olympus instructed customers to immediately stop using the affected products and remove them from circulation.

The company first issued an urgent medical device removal notice to healthcare providers in January.

The recall adds to mounting scrutiny surrounding Olympus’s endoscope safety and contamination concerns.

In December 2024, the FDA issued a separate safety alert regarding Olympus MAJ-891 endoscope forceps and irrigation plug components following reports of infections, sepsis, urinary tract infections, and one death allegedly linked to inadequate cleaning and disinfection procedures.

Olympus has also faced prior regulatory criticism over contamination risks associated with reusable duodenoscopes.

In 2023, the FDA issued a warning letter citing unresolved quality-control problems with Olympus duodenoscopes, specialized scopes used in gastrointestinal procedures.

Regulators previously reported that nearly 7% of reusable duodenoscopes tested positive for high-risk bacteria even after reprocessing, contributing to a broader industry push toward disposable endoscope systems.

The latest recall is expected to further intensify concerns about reusable endoscope safety, device durability, and infection risks associated with gastrointestinal and pulmonary procedures.

A new study published in the Journal of Hospital Infection is adding to ongoing concerns about infection risks tied to reusable endoscopes and duodenoscopes.

Researchers investigated an outbreak of drug-resistant Klebsiella pneumoniae linked to contaminated gastrointestinal endoscopes at a German hospital, where 32 patients were affected, and six died.

According to the study, investigators found that contaminated endoscopes continued testing positive for dangerous bacteria even after undergoing standard cleaning and disinfection procedures.

Researchers identified residual moisture, scratches inside device channels, and biofilm buildup that may have allowed bacteria to survive reprocessing.

The outbreak strain was recovered from multiple patients and from reprocessed endoscopes themselves, supporting concerns that reusable scopes can transmit infections between patients despite compliance with manufacturer instructions.

The findings echo longstanding allegations raised in Olympus duodenoscope lawsuits and other endoscope litigation, where patients claim device designs made the scopes difficult to fully clean and disinfect.

Federal regulators and researchers have spent years investigating contamination risks tied to reusable duodenoscopes used during ERCP procedures.

Researchers concluded that biofilm formation and persistent moisture inside endoscope channels remain major patient safety concerns and warned that the “margin of safety” in endoscope reprocessing may be very small.

A newly published study is raising renewed concerns about Olympus duodenoscope contamination risks, suggesting that current testing methods may fail to reliably detect dangerous bacteria on reusable scopes used during ERCP procedures.

The research, published in Gastrointestinal Endoscopy in 2025, analyzed seven years of microbiologic surveillance data involving reusable duodenoscopes used at a major medical center in the Netherlands.

Researchers reviewed 556 duodenoscope cultures and found that 33.3% tested positive for microorganisms of gut or oral origin, including bacteria linked to serious infections.

More concerning, the study concluded that current duodenoscope culturing methods may miss contamination at a significant rate.

Depending on the testing scenario, researchers estimated that culture sensitivity may be as low as 82.2%, meaning contaminated scopes could be cleared for continued patient use after false-negative test results.

The researchers estimated that between 12.3% and 23.7% of ERCP procedures during the study period may have involved contaminated duodenoscopes.

The study warned that reliance on a single negative culture result to return a duodenoscope to service “should be re-evaluated,” particularly because biofilm inside endoscope channels may prevent proper sampling and allow bacteria to evade detection.

Olympus duodenoscopes have been at the center of litigation and regulatory scrutiny for years following outbreaks of antibiotic-resistant infections linked to contaminated scopes.

Federal health agencies previously tied certain outbreaks to design features that allegedly made the devices difficult to fully clean and disinfect between procedures.

Hundreds of patients nationwide have filed Olympus duodenoscope lawsuits alleging they developed severe infections after undergoing ERCP procedures involving contaminated reusable scopes.

Plaintiffs have claimed manufacturers failed to adequately warn hospitals and physicians about contamination risks tied to the devices’ design.

The new study may add to ongoing concerns surrounding whether existing reprocessing and surveillance protocols are sufficient to prevent patient exposure to contaminated duodenoscopes, especially as researchers concluded that contaminated devices may remain in clinical use despite repeated testing.