Olympus Scope Lawsuit Update: Injuries, Recall Status, and Legal Options

FDA has documented infections associated with reprocessed duodenoscopes even when health care facilities reported following manufacturer cleaning and disinfection instructions. In July 2026, FDA classified an Olympus distal-cover recall involving the TJF-Q190V duodenoscope, while separate 2026 actions involved Olympus endoscope reprocessing equipment and accessories.

Patients who developed a serious infection after ERCP, endoscopy, bronchoscopy, colonoscopy, or another scope procedure should preserve medical records, procedure reports, microbiology results, hospitalization records, and information identifying the scope used.

Quick Facts

• FDA has documented infection-transmission concerns involving reusable duodenoscopes and challenges associated with effective reprocessing.
• An open 2026 FDA Class II recall involves Olympus Single Use Distal Covers used with the TJF-Q190V duodenoscope.
• Current attorney investigations are reviewing serious-infection claims involving Olympus duodenoscopes and other reusable scopes.
• Potential claims may depend on device identification, infection timing, culture results, reprocessing evidence, medical complications, and causation.

Latest Olympus Scope Recall and Lawsuit Developments

August 2026

• August 14, 2026 – A current legal-investigation update reported that attorneys are reviewing claims involving patients who developed serious infections or other complications following procedures using Olympus reusable scopes. The investigation includes duodenoscopes, bronchoscopes, colonoscopes, gastroscopes, and other endoscopic devices and does not establish liability in any individual case [1]

July 2026

• July 7, 2026 – FDA posted an open Class II recall involving Olympus Single Use Distal Cover MAJ-2315, used with the EVIS EXERA III TJF-Q190V duodenoscope. FDA identified device design as the cause, and Olympus instructed customers to remove the previous distal-cover design from inventory [2]

March 2026

• March 20, 2026 – FDA classified an open recall involving Olympus OER-Pro and OER-Elite endoscope reprocessors because certain MAJ-1443 and MAJ-1444 valves were no longer considered compatible with those automated reprocessing systems. Olympus instructed facilities to stop reprocessing the affected valves in those systems and follow updated instructions [3]

November 2025

• November 21, 2025 – FDA posted an Olympus TJF-Q190V duodenoscope recall following continued reports of positive cultures and infections. Olympus updated reprocessing materials in an effort to reduce potential deviations in cleaning and disinfection procedures [4]

What Are Olympus Scopes?

Olympus manufactures reusable medical scopes that allow physicians to view or treat areas inside the body without open surgery.

Products discussed in current litigation investigations include Olympus duodenoscopes, endoscopes, bronchoscopes, colonoscopes, and gastroscopes. These instruments may be used during ERCP and other gastrointestinal, pulmonary, or diagnostic procedures.

Because many scopes are reused, they must be thoroughly cleaned, disinfected, dried, maintained, and stored between patients.

Why Have Olympus Duodenoscopes Raised Infection Concerns?

FDA explains that duodenoscopes contain complex internal parts and narrow channels that can make complete cleaning and disinfection difficult.

If blood, tissue, fluid, or microorganisms remain inside the device after reprocessing, contamination can potentially be transferred to another patient during a later procedure.

FDA has reported infections associated with reprocessed duodenoscopes even where facilities stated that manufacturer cleaning and disinfection instructions had been followed [5]

What Is ERCP?

Endoscopic retrograde cholangiopancreatography, or ERCP, is a procedure used to diagnose and treat conditions involving the bile ducts, pancreatic ducts, gallbladder, and pancreas.

During ERCP, a duodenoscope is passed through the mouth, esophagus, and stomach into the duodenum. Instruments may then be passed through the scope to remove stones, place stents, obtain tissue, or perform other treatment.

FDA says more than 500,000 ERCP procedures are performed annually in the United States.

Why Are Duodenoscopes Difficult to Reprocess?

Duodenoscopes contain multiple internal channels and moving components that must be cleaned between procedures.

Older designs include a complex elevator mechanism near the distal end of the device. Tissue or fluid can remain in difficult-to-access spaces if reprocessing is incomplete or ineffective.

Reprocessing may include immediate pre-cleaning, leak testing, manual brushing and flushing, high-level disinfection or sterilization, drying, inspection, and appropriate storage.

Can Infection Occur Even After Reprocessing?

Yes. FDA has investigated infection clusters in which health care facilities reported following recommended reprocessing procedures.

The agency has said that contamination involving duodenoscopes can occur despite adherence to manufacturer cleaning and disinfection instructions because of the devices’ complex design.

This does not mean every infection after an endoscopy was caused by a contaminated scope. Patient-specific microbiology, timing, medical history, facility records, and device evidence are needed to evaluate causation.

What Did FDA Find About Duodenoscope Contamination?

FDA’s postmarket surveillance work found higher-than-expected contamination rates in certain reusable duodenoscopes following reprocessing.

These findings led FDA and manufacturers to pursue design changes, revised reprocessing instructions, postmarket studies, increased servicing requirements, and disposable-component technologies.

FDA has continued encouraging movement toward duodenoscope designs with disposable components or fully disposable systems where appropriate.

What Is the 2026 Olympus Distal Cover Recall?

The July 2026 FDA recall concerns Olympus Single Use Distal Cover MAJ-2315, an accessory used with the EVIS EXERA III TJF-Q190V duodenoscope.

The distal cover is designed to fit over the end of the insertion tube and around the forceps elevator area.

FDA identifies the recall as Class II, recall number Z-2676-2026, and lists device design as the cause. Olympus developed a new version of the distal cover and instructed customers to remove the previous design from inventory.

What Is the TJF-Q190V Duodenoscope?

The Olympus TJF-Q190V is an EVIS EXERA III duodenovideoscope used during endoscopic and endoscopic-surgical procedures.

FDA records also show a separate recall involving the TJF-Q190V following reports of infections and positive cultures. Olympus issued updated reprocessing materials intended to improve understanding of cleaning steps and reduce deviations during reprocessing.

The existence of a recall does not establish that every TJF-Q190V was contaminated or that every infection following ERCP was caused by the device.

Why Do Olympus Endoscope Reprocessor Recalls Matter?

Automated endoscope reprocessors are machines used by health care facilities during high-level disinfection of reusable scopes and accessories.

FDA’s March 2026 Olympus recall states that certain air/water valves were no longer considered compatible with OER-Pro and OER-Elite automated reprocessors. Olympus instructed facilities to stop using those reprocessors for the affected valves and follow revised reprocessing instructions.

These actions demonstrate why the cleaning system, accessories, instructions, staff training, maintenance history, and actual scope involved may all matter when investigating an infection claim.

What Infections Have Been Associated With Olympus Duodenoscopes?

FDA records and adverse-event reports have included bacterial infections involving organisms such as Pseudomonas aeruginosa, carbapenem-resistant Enterobacteriaceae, and other potentially drug-resistant bacteria.

Infections can become serious when bacteria enter the bloodstream or spread beyond the original site.

Patients may require antibiotics, hospitalization, intensive care, additional procedures, or prolonged medical treatment depending on the organism and severity of illness.

What Is Sepsis?

Sepsis is a dangerous systemic response to infection that can cause organ dysfunction and become life-threatening.

A patient who develops fever, low blood pressure, confusion, rapid heart rate, breathing difficulty, or other concerning symptoms after an endoscopic procedure should seek appropriate medical evaluation.

Whether sepsis was caused by scope-related contamination must be established from the clinical history, cultures, procedure records, timing, and other evidence.

What Happened With Olympus’s 2018 Criminal Case?

In December 2018, Olympus Medical Systems Corporation pleaded guilty to federal charges involving failures to file required adverse-event reports concerning infections associated with its TJF-Q180V duodenoscope.

The Justice Department said Olympus admitted failures involving infection events in Europe and continued distributing affected duodenoscopes in the United States. The company was fined $80 million and ordered to forfeit $5 million [6]

That criminal case involved regulatory-reporting violations and historical devices. It does not automatically establish liability in a current patient’s civil claim.

What Injuries Are Being Investigated?

Current legal investigations focus primarily on serious infections and infection-related complications following procedures involving reusable Olympus scopes.

Potential injuries may include bloodstream infection, sepsis, organ complications, prolonged hospitalization, additional procedures, long-term medical treatment, or death.

Claims should be based on documented medical findings rather than assuming that symptoms after a procedure were caused by a scope.

How Do I Know Whether an Olympus Scope Was Used?

Patients can request medical records from the hospital, endoscopy center, or clinic where the procedure was performed.

Procedure reports, nursing records, equipment logs, reprocessing records, device tracking information, and operative records may identify the manufacturer, model, serial number, or equipment used.

Hospitals may also maintain endoscope-tracking systems that link a specific scope to a patient procedure.

Who May Be Affected?

Potentially affected patients include people who underwent ERCP, endoscopy, bronchoscopy, colonoscopy, or another procedure involving a reusable Olympus scope and later developed a serious infection.

A short interval between the procedure and infection may be relevant, but timing alone does not prove causation.

Families of patients who died following serious infection-related complications may also have potential legal rights depending on the evidence and applicable law.

Who May Be Liable?

Potentially responsible parties may include a medical-device manufacturer, distributor, hospital, endoscopy center, reprocessing provider, maintenance contractor, or another entity depending on how the infection occurred.

Possible theories may involve defective design, inadequate warnings, reprocessing problems, negligent maintenance, failure to follow cleaning protocols, or other claims available under applicable law.

Liability must be determined individually. A product recall, infection cluster, or FDA enforcement action does not by itself establish that a particular defendant caused a particular patient’s infection.

What Is the Current Olympus Scope Lawsuit Status?

Attorneys are currently investigating potential claims involving patients who developed serious infections or related complications following procedures using Olympus reusable scopes.

The current investigation should not be described as a single nationwide settlement, certified class action, or court finding that all Olympus scopes are defective.

Individual cases may depend heavily on the scope model, procedure date, organism identified, facility reprocessing history, medical course, and available device-tracking records.

Do I Qualify?

• Did you undergo an ERCP, endoscopy, bronchoscopy, colonoscopy, or related procedure involving an Olympus reusable scope?
• Did you subsequently develop a serious bacterial infection, bloodstream infection, sepsis, or other infection-related complication?
• Did the illness require hospitalization, IV antibiotics, intensive care, additional procedures, or other significant medical treatment?
• Do you have procedure records, culture results, hospitalization records, device information, or other evidence linking the infection to the procedure?

An individualized legal review can determine whether the procedure history, scope identification, microbiology, timing, reprocessing evidence, injuries, damages, and filing deadlines support a claim.

What Evidence Should I Preserve?

Request and preserve the procedure report, operative report, hospital records, culture results, laboratory reports, antibiotic records, discharge summaries, billing records, and follow-up treatment documentation.

Device-specific evidence may include the Olympus model and serial number, reprocessing logs, automated-reprocessor records, maintenance history, scope-tracking records, infection-control reports, and communications from the medical facility.

Families should also preserve death certificates, autopsy findings, infectious-disease consultations, and related records when a fatal infection is involved.

Do I Have an Olympus Scope Lawsuit?

If you or a loved one developed a serious infection or other documented complication after a procedure involving an Olympus scope, you may have legal options. Contact Schmidt & Clark for a free case review.

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Important Legal Actions or Recalls

Event	Month/Year	Type	Status	Source	Notes
Olympus scope claims investigation	August 2026	Attorney investigation	Claims under review	Cohen Milstein	Serious infection claims
MAJ-2315 distal cover recall	July 2026	Class II recall	Open	FDA	Device design cited
Olympus reprocessor correction	March 2026	Class II recall	Open	FDA	Reprocessing compatibility issue
TJF-Q190V recall	November 2025	Class II recall	Open	FDA	Infection reports cited
Olympus criminal resolution	December 2018	Federal criminal case	Guilty plea	DOJ/FDA	Reporting violations

Potential Compensation

Potential compensation may include hospitalization, emergency treatment, infectious-disease care, antibiotics, surgery, rehabilitation, follow-up treatment, and future medical expenses supported by the individual case.

Additional damages may include lost wages, reduced earning capacity, pain and suffering, long-term complications, disability, and wrongful-death damages where permitted by applicable law.

Compensation amounts vary by case. Past results do not guarantee future outcomes.

Legal Process Overview

Free case review: The initial review may address the procedure, Olympus scope identification, infection diagnosis, culture results, hospitalization, medical history, and available records.

Investigation. Attorneys may review medical records, device-tracking logs, scope model information, reprocessing records, infection-control evidence, FDA materials, and expert analysis.

Filing. A lawsuit may be filed when available evidence and governing law support one or more claims. Filing deadlines vary by jurisdiction.

Discovery/negotiation: The parties may exchange scope-design information, reprocessing instructions, maintenance records, adverse-event information, medical evidence, microbiology evidence, expert opinions, and testimony while discussing possible resolution.

Resolution: A case may conclude through settlement, dismissal, court ruling, or trial. No outcome or timeline can be guaranteed.

Frequently Asked Questions About Olympus Scopes

Do I Have an Olympus Scope Lawsuit?

A potential claim may warrant review if you developed a serious infection after a procedure involving a reusable Olympus scope. Eligibility depends on scope identification, procedure timing, microbiology, causation, damages, available evidence, and applicable law.

What Evidence May Support an Olympus Scope Lawsuit?

Important evidence may include procedure reports, scope model and serial numbers, culture results, hospitalization records, antibiotic treatment, reprocessing logs, and infection-control records. Device-tracking information may help establish which scope was used.

What Is an Olympus Duodenoscope?

A duodenoscope is a flexible reusable endoscope used primarily during ERCP procedures involving the bile and pancreatic ducts. Olympus manufactures multiple duodenoscope models, including the TJF-Q190V.

Why Can Reusable Scopes Transmit Infection?

Biological material or microorganisms can remain inside a reusable scope if cleaning and disinfection are incomplete or ineffective. FDA has investigated infections occurring even when facilities reported following recommended duodenoscope reprocessing procedures.

Is the Olympus TJF-Q190V Recalled?

FDA records show a recall involving the TJF-Q190V following continued reports of infections and positive cultures. A separate 2026 recall also involves an Olympus single-use distal cover used with that duodenoscope.

What Is the 2026 Olympus Distal Cover Recall?

FDA classified a Class II recall involving Olympus MAJ-2315 distal covers used with the TJF-Q190V. Olympus developed a new version of the component and instructed facilities to remove the previous design.

What Infections Have Been Reported After Olympus Scope Procedures?

FDA reports have included infections involving organisms such as Pseudomonas and carbapenem-resistant bacteria. The microorganism involved in an individual case should be confirmed through laboratory and medical records.

How Can I Find Out Which Scope Was Used?

Request your complete procedure and hospital records and ask the facility for device-tracking information. Procedure logs or endoscopy records may identify the scope manufacturer, model, serial number, and reprocessing history.

References

1. https://www.cohenmilstein.com/case-study/olympus-scope-litigation/
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220844
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=218481
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=216332
5. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes
6. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/doj-press-releases-involving-fda-oci/december-10-2018-olympus-medical-systems-corporation-former-senior-executive-plead-guilty