Olympus Corporation — the world's largest manufacturer of endoscopes — has faced more than a decade of FDA enforcement actions, Senate investigations, and a federal criminal guilty plea for concealing contamination risks in its duodenoscope and bronchoscope lines. Patients at hospitals across the United States were exposed to drug-resistant superbugs through scopes that Olympus knew could not be reliably sterilized.
Legally Reviewed by Nick Reyes, Partner, The Alvarez Law Firm
If you had an ERCP, bronchoscopy, or upper endoscopy and later developed a serious infection, a contaminated Olympus scope may be the source — and you may have a legal claim against Olympus, the hospital, or both.
Olympus Corporation is a Japanese medical device manufacturer that, for years, supplied roughly 70 to 80 percent of the duodenoscopes used in U.S. hospitals. Duodenoscopes are long, flexible cameras used in a procedure called ERCP (endoscopic retrograde cholangiopancreatography) to diagnose and treat conditions of the bile duct and pancreas. Olympus also manufactures bronchoscopes used in lung procedures and a range of other endoscopes.
Beginning in the early 2010s, hospitals began tracing deadly superbug outbreaks back to contaminated Olympus scopes. Patients who underwent routine ERCP procedures left hospitals with drug-resistant infections they had not arrived with. Many were hospitalized for weeks. Some died.
An Olympus scope lawsuit is a legal claim by a patient — or the family of a patient who died — alleging that Olympus designed and sold scopes it knew could not be safely reprocessed, and that the company concealed or minimized those risks from hospitals and the FDA. See our page on ERCP scope infection lawsuits for the procedure-specific record.
The primary models involved in documented outbreaks and litigation are:
On June 24, 2025, the FDA issued an import alert blocking 58 Olympus device models from entering the United States, citing quality system violations at the Aizu, Japan facility where most Olympus endoscopes are made.
The TJF-Q180V and Q190V duodenoscopes have a hinged elevator mechanism at their tip — a tiny lever that steers instruments into the bile duct. The FDA's own testing found that approximately 1 in 20 duodenoscopes remained contaminated with patient material even after following Olympus's cleaning instructions exactly. Bacteria form a biofilm inside the elevator channel that resists standard liquid disinfection. For a detailed breakdown, read about the Olympus endoscope design defect.
The federal record on Olympus spans more than a decade of adverse event reports, safety communications, warning letters, a criminal conviction, and an active import alert. This is not a dispute about whether the scopes caused infections — the government has documented it in detail.
First documented U.S. outbreaks linked to Olympus TJF-Q180V duodenoscopes. Virginia Mason Medical Center in Seattle traces 39 patient infections to contaminated Olympus scopes; 18 patients die. Hospitals follow Olympus cleaning instructions throughout.
UCLA Ronald Reagan Medical Center discloses 179 patients potentially exposed to CRE superbugs; 7 confirmed infections, 2 deaths. Cedars-Sinai Medical Center discloses approximately 68 additional exposures. Both hospitals used Olympus duodenoscopes and followed manufacturer instructions.
FDA issues Safety Communication on duodenoscope reprocessing. The U.S. Senate HELP Committee publishes its Preventable Tragedies report, documenting Olympus's failure to report known contamination problems to the FDA and its years of inaction.
Olympus issues a voluntary recall of the TJF-Q180V and begins distributing a redesigned model. FDA requires post-market surveillance studies, which continue to find contamination after reprocessing.
Olympus Medical Systems Corp. pleads guilty in U.S. federal court to failing to report required safety information to the FDA. The company enters an $85 million resolution with the Department of Justice — the largest criminal fine in FDA history at the time for a medical device company.
FDA pushes Olympus and other duodenoscope makers toward disposable elevator caps and single-use scopes. Post-market surveillance continues to identify contamination risk in reusable models. ECRI Institute names duodenoscope reprocessing among its top hospital hazard lists multiple years running.
FDA issues an import alert blocking 58 Olympus device models from entering the United States. The alert cites quality system violations at Olympus's Aizu, Japan manufacturing facility. As of mid-2026, the import alert remains in place. Three additional Olympus recalls followed in 2026 across insufflation units, disposable accessories, and the OER-Pro automated endoscope reprocessor. See our full FDA warnings page for the complete regulatory timeline.
There is no single checklist that answers this for every patient — case facts vary too much. But the patterns below describe who typically has grounds for a case review. The review itself is free, confidential, and takes about 15 minutes.
Use our 3-part qualification test to check your situation in about 60 seconds, or call for a free, no-obligation case review. Our medical-legal team — which includes Herb Borroto, M.D., J.D., a physician and attorney who reviews the actual medical records — will tell you honestly whether we believe a case can be built.
The core product liability theory is that Olympus designed a scope — specifically the TJF-Q180V and Q190V duodenoscopes — with a closed elevator channel that could not be reliably decontaminated between patients. Olympus knew this from its own engineering data, from European outbreak reports beginning in 2012, and from the growing U.S. outbreak record. Instead of redesigning the scope or issuing a clear warning, the company continued marketing the product and, as the 2018 federal guilty plea established, failed to file required adverse event reports with the FDA.
A design defect claim does not require showing that the hospital did anything wrong. It only requires showing the product was unreasonably dangerous in its design and that Olympus knew — or should have known — of the risk.
Separately from Olympus's liability, a hospital may be liable if it failed to take steps the FDA and ECRI Institute had specifically recommended to reduce contamination risk — steps beyond Olympus's own cleaning instructions. Those additional measures included microbiological surveillance culturing of scopes, double high-level disinfection, and, after 2019, mandatory implementation of disposable elevator caps or single-use scopes where available.
Our team reviews both theories in every case. The hospital records, scope service logs, and reprocessing documentation are the key evidence. Learn more about hospital reprocessing negligence claims and the specific standards hospitals were expected to meet.
Every state sets its own filing deadline for personal injury and product liability cases. Missing that deadline generally ends the right to recover. Here is what you need to understand.
State statutes of limitations for product liability and personal injury cases vary widely, but most fall in the 2-to-4-year range. Critically, most states start that clock on the date of discovery — the date a patient knew or reasonably should have known that a contaminated scope caused the infection — not the date of the original procedure. Because most scope infection patients were never told the scope was the source of their illness, and because the contamination story did not reach ordinary consumers in any meaningful way until the FDA's June 2025 import alert and subsequent mainstream news coverage, many patients' discovery clocks started in 2025 or 2026.
The interaction between the discovery rule, the date of the procedure, and state-specific tolling provisions is fact-specific and requires a legal analysis. Patients who had procedures in 2019, 2020, 2021, or even earlier may still have viable cases under the discovery rule — but only if they act before the applicable deadline. Our litigation update from mid-June 2026 explains why the filing clock is the most urgent issue for patients still on the fence. A free case review will include a preliminary assessment of your state's applicable deadline.
If a family member died as a result of a scope-acquired infection, a wrongful death claim may be available to surviving family members. Wrongful death statutes have their own filing deadlines, which are often shorter than personal injury statutes. If the patient died within the past two to four years, the family should seek a case review promptly.
Our team includes Herb Borroto, M.D., J.D. — a physician and attorney who personally reviews medical records in scope infection cases. The ability to read a culture result, evaluate a reprocessing log, and connect a clinical infection to a contaminated device is not something most law firms can offer. It is the reason our case evaluations carry more weight.
We represent patients in all 50 states. The contaminated scope problem was national in scope — hospitals from Seattle to Miami to Boston used the same Olympus equipment, and patients across the country were harmed. Your state of residence and the state where the procedure occurred both matter for filing purposes; we evaluate both.
The initial case review is free and confidential. If we take your case, we work on a contingency basis — no fees unless we recover compensation for you. Patients harmed by defective medical devices should not have to pay upfront to access legal help.
Answers to the questions we hear most often from scope infection patients and their families.
An Olympus scope lawsuit is a product liability or medical malpractice claim brought by a patient who developed a serious infection — typically a drug-resistant superbug such as CRE, VRE, ESBL, Pseudomonas, or MRSA — after an endoscopic procedure performed with an Olympus duodenoscope or bronchoscope. The lawsuits allege that Olympus designed scopes that could not be reliably sterilized between patients, failed to warn hospitals and patients about the contamination risk, and continued selling those scopes after the company knew of the danger. Some cases also name the hospital for negligent reprocessing of the scope.
The primary models at issue are the TJF-Q180V and TJF-Q190V duodenoscopes, used in ERCP procedures. Both models have a hinged elevator mechanism at the tip that the FDA has identified as the root cause of contamination — it traps biological material in a space that standard hospital reprocessing cannot reliably reach. Olympus bronchoscopes in the BF series have also been cited in FDA adverse event reports for post-procedure infections. On June 24, 2025, the FDA issued an import alert blocking 58 Olympus device models from U.S. entry pending resolution of quality system violations at the Aizu, Japan manufacturing facility.
Possibly. Every state has a statute of limitations for product liability and personal injury claims, but most states start that clock on the date the patient discovered — or reasonably should have discovered — that a contaminated scope caused the infection. Most patients were never told a scope was the source of their illness, and the full public record of Olympus scope dangers did not reach ordinary consumers until the FDA's June 2025 import alert and the wave of mainstream news coverage that followed. For many patients, that is when the discovery clock realistically starts — not the date of the original procedure. Do not assume the deadline has passed without a case review.
The most commonly documented post-procedure infections linked to contaminated Olympus scopes include: carbapenem-resistant Enterobacteriaceae (CRE), vancomycin-resistant Enterococcus (VRE), extended-spectrum beta-lactamase (ESBL) producing bacteria, Pseudomonas aeruginosa, and methicillin-resistant Staphylococcus aureus (MRSA). Sepsis, cholangitis, and bloodstream infections following an ERCP or bronchoscopy are the clinical patterns most worth reviewing. If you were hospitalized for a serious infection within weeks to months after an endoscopic procedure, that timeline and diagnosis are what a case review will examine.
Olympus scope lawsuits typically proceed on two legal theories, sometimes both. The first is product liability — specifically design defect and failure to warn. Olympus knew the elevator-channel design trapped bacteria that standard reprocessing could not eliminate, and courts have found the company continued marketing the scopes without adequate warning to hospitals or patients. The second is hospital negligence — if a hospital failed to follow enhanced reprocessing protocols recommended by the FDA or ECRI Institute, or used equipment it knew was defective, it may share liability for the infection. Our firm evaluates both theories in every case review.
Every factual claim on this page is supported by a verifiable public source. Click any source to read the original.
Browse the full library of contaminated endoscope and Olympus scope investigation pages.
Duodenoscope-linked outbreaks and ERCP claims.
Timeline of FDA recalls, warnings, and import alerts.
Find out in 60 seconds if you have a case.
The closed-channel elevator that resists sterilization.
Cleaning shortcuts that put patients at risk.
How design flaws turn scopes into superbug carriers.
CRE, MDRO, sepsis warning signs to watch for.
State-by-state filing deadlines and the discovery rule explained.
The drug-resistant bacteria documented in scope outbreaks, in plain English.
Lung procedure scope infections and BF series bronchoscope claims.
Import alert anniversary, 2026 recall pattern, and what patients should do now.
Latest FDA actions, MDL updates, and case news.
A free, confidential case review with our team includes a preliminary medical-legal assessment of your records and your state's filing deadline. There is no cost, no obligation, and no fees unless we recover compensation for you.
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What Happens Next
If your information appears to qualify you for help, a lawyer or someone from their team will reach out to you. If you don't hear back within seven days, please speak with another law firm — every legal matter has a filing deadline, and waiting too long can cost you the right to recover.
