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

FDA has documented infection concerns involving reusable Olympus duodenoscopes and has continued taking regulatory action involving Olympus scopes, distal covers, and endoscope-reprocessing equipment. A July 2026 Class II recall involves the MAJ-2315 distal cover used with the TJF-Q190V duodenoscope.

A qualifying procedure or diagnosis does not by itself establish that an Olympus device caused an injury. Medical records, procedure information, device identification, infection timing, microbiology, and other evidence must be evaluated individually.

Quick Facts

• Schmidt & Clark currently screens certain Olympus scope claims involving qualifying endoscopic procedures performed from 2018 to the present.
• Potentially qualifying injuries include perforation, device breakage, serious hemorrhage, sepsis, bacteremia, specified infections, and death.
• FDA has documented infection-transmission concerns involving reusable duodenoscopes and difficulties associated with effective reprocessing.
• An open 2026 FDA Class II recall involves Olympus MAJ-2315 distal covers used with TJF-Q190V duodenoscopes.

Latest Olympus Scope Recall and Lawsuit Developments

July 2026

• July 7, 2026 – FDA posted an open Class II recall involving Olympus Single Use Distal Cover MAJ-2315, an accessory for the EVIS EXERA III TJF-Q190V duodenoscope. FDA identifies device design as the recall cause, and Olympus instructed customers to remove the previous distal-cover design from inventory [1]

March 2026

• March 20, 2026 – FDA classified an Olympus recall involving OER-Pro and OER-Elite endoscope reprocessors after certain MAJ-1443 and MAJ-1444 valves were no longer considered compatible with those systems. Olympus instructed facilities to change how the affected components were reprocessed [2]

November 2025

• November 21, 2025 – FDA posted an Olympus TJF-Q190V recall following continued reports of infections and positive cultures. Olympus issued updated reprocessing materials intended to reduce deviations during cleaning and disinfection [3]

December 2018

• December 10, 2018 – Olympus Medical Systems Corporation pleaded guilty to federal charges involving failures to submit required adverse-event reports concerning infections associated with TJF-Q180V duodenoscopes. The company was fined $80 million and ordered to forfeit $5 million [4]

What Are Olympus Scopes?

Olympus manufactures reusable and single-use endoscopic devices used to examine and treat areas inside the body.

Products may include duodenoscopes, bronchoscopes, colonoscopes, gastroscopes, cystoscopes, ureteroscopes, hysteroscopes, and other endoscopic instruments. Many reusable devices require detailed cleaning, high-level disinfection, drying, maintenance, and storage between patients.

Which Procedures Meet Schmidt & Clark’s Current Screening Criteria?

For current case screening, the patient must have undergone at least one of the following procedures from 2018 to the present:

• Laparoscopy
• Colonoscopy
• ERCP
• Bronchoscopy
• Upper endoscopy
• Ureteroscopy
• Hysteroscopy
• Sinus endoscopy
• Cystoscopy

These are Schmidt & Clark’s current intake criteria, not FDA eligibility standards or a legal determination that every patient who underwent one of these procedures has a claim.

Which Injuries Are Currently Being Screened?

A qualifying procedure must also be associated with a serious injury or complication that meets current case-screening requirements.

• Organ or tissue damage, including perforation
• Breaking or dislodging of an endoscopic device or component
• Procedure-related hemorrhaging resulting in prolonged or unplanned hospitalization, blood transfusion, or other significant medical intervention
• Death resulting from infection or component failure
• Sepsis or bacteremia
• Bacterial infection requiring hospitalization within 90 days of the procedure
• Pneumonia or another severe pulmonary infection within 90 days
• Tuberculosis diagnosed within 90 days
• HIV diagnosed within 90 days
• A drug-resistant infection, such as CRE or drug-resistant E. coli, diagnosed within 180 days

The 90- and 180-day periods are legal-intake screening parameters. They do not establish that an endoscope caused an infection, and diagnosis within one of these windows still requires individualized causation review.

Why Have Olympus Duodenoscopes Raised Infection Concerns?

FDA has explained that reusable duodenoscopes contain complex components and narrow channels that can make effective reprocessing difficult.

If biological material or microorganisms remain after cleaning and disinfection, contamination may potentially be transferred during a later procedure. FDA has investigated infections associated with reprocessed duodenoscopes even where facilities reported following manufacturer instructions [5]

This history does not mean every infection following endoscopy resulted from a contaminated Olympus device.

What Is ERCP?

Endoscopic retrograde cholangiopancreatography, or ERCP, is used to diagnose and treat problems involving the bile ducts and pancreatic ducts.

A duodenoscope passes through the mouth and gastrointestinal tract into the duodenum. Instruments can then be passed through the device to remove stones, place stents, collect tissue, or perform other treatment.

Can Reprocessed Scopes Still Carry Bacteria?

FDA has investigated circumstances in which duodenoscopes remained contaminated after reprocessing.

Possible explanations can involve device design, damaged components, incomplete manual cleaning, inadequate drying, incorrect reprocessing, maintenance problems, or other factors. Establishing the source of an individual infection may require microbiologic comparison, device tracking, and facility records.

What Is the Olympus TJF-Q190V Recall?

FDA records document an Olympus recall involving the EVIS EXERA III TJF-Q190V duodenoscope following continued reports of infections and positive cultures.

Olympus issued updated reprocessing materials intended to improve understanding of cleaning procedures. FDA’s database lists the recall as open and classified.

A separate 2026 action involves the MAJ-2315 single-use distal cover used with this duodenoscope.

What Is the 2026 Olympus Distal Cover Recall?

The MAJ-2315 distal cover fits over the distal end of the TJF-Q190V and surrounds the forceps-elevator area.

FDA identifies the July 2026 action as Class II recall Z-2676-2026 and lists device design as the cause. Olympus developed a replacement design and instructed affected facilities to remove the previous version.

Why Do Endoscope Reprocessor Problems Matter?

Automated endoscope reprocessors are used during high-level disinfection of reusable scopes and accessories.

The March 2026 Olympus action involving OER-Pro and OER-Elite systems illustrates why scope cleaning cannot be evaluated solely by looking at the endoscope. Reprocessing equipment, compatible accessories, instructions, maintenance, staff practices, and drying procedures may all become relevant.

Can an Endoscope Cause Perforation or Other Tissue Damage?

Perforation can occur when tissue or an organ is unintentionally punctured during an endoscopic procedure.

A potential product case may warrant investigation when the injury coincides with device breakage, dislodgment, malfunction, or another suspected equipment problem. Procedure reports, imaging, repair surgery records, and device records can help determine what occurred.

What If an Endoscopic Component Broke or Became Dislodged?

A broken or detached component may require retrieval during the original procedure or through additional endoscopy or surgery.

Relevant evidence can include operative records, incident reports, photographs, maintenance records, service history, and the recovered component. The existence of a broken component does not by itself establish why it failed or who is legally responsible.

When Can Hemorrhaging Meet the Injury Criteria?

Minor expected bleeding generally does not satisfy current screening requirements by itself.

The criteria focus on procedure-related hemorrhage serious enough to cause an unplanned or prolonged hospital stay, blood transfusion, or another significant medical intervention associated with pain and suffering.

Which Infections May Qualify?

Current screening includes sepsis, bacteremia, certain bacterial infections, severe pulmonary infections, tuberculosis, HIV, and some drug-resistant infections when the required timing and treatment criteria are met.

FDA has documented duodenoscope-associated reports involving organisms including Pseudomonas aeruginosa and carbapenem-resistant Enterobacteriaceae. The microorganism involved in an individual case should be established through laboratory records rather than assumed from symptoms.

What Are CRE and Other Drug-Resistant Infections?

CRE refers to carbapenem-resistant Enterobacteriaceae, a group of bacteria resistant to important antibiotics.

Current screening criteria include drug-resistant infections such as CRE or resistant E. coli diagnosed within 180 days of a qualifying endoscopic procedure. Culture and susceptibility results are particularly important for these claims.

How Do I Find Out Which Olympus Scope Was Used?

Patients can request complete records from the hospital, surgery center, endoscopy center, or physician that performed the procedure.

Procedure reports, operative records, equipment logs, device-tracking records, reprocessing logs, and maintenance information may identify the manufacturer, model, serial number, and accessories involved.

Who May Be Affected?

Potential clients include patients who underwent one of Schmidt & Clark’s qualifying endoscopic procedures from 2018 to the present and subsequently experienced a qualifying injury.

Families may also warrant legal review when a patient died from an infection or alleged endoscopic component failure.

The procedure date and injury criteria are screening requirements rather than guarantees that a lawsuit can be filed successfully.

Who May Be Liable?

Potentially responsible parties may include a device manufacturer, component manufacturer, distributor, medical facility, reprocessing provider, or maintenance contractor depending on the evidence.

Potential theories may involve design or manufacturing defects, inadequate warnings, component failure, negligent maintenance, or reprocessing problems.

Liability requires individualized proof of product involvement, defect or negligence, causation, and damages.

What Is the Current Olympus Scope Lawsuit Status?

Attorneys are investigating potential Olympus scope claims involving serious infections and other significant endoscopic complications [6]

The FDA recalls and historical enforcement actions discussed here provide regulatory context but do not establish civil liability for an individual patient’s injury.

Do I Qualify?

• Did you undergo laparoscopy, colonoscopy, ERCP, bronchoscopy, upper endoscopy, ureteroscopy, hysteroscopy, sinus endoscopy, or cystoscopy from 2018 to the present?
• Did you suffer perforation, organ or tissue damage, device breakage, serious hemorrhaging, sepsis, bacteremia, or death related to infection or component failure?
• Did you develop a qualifying hospitalized infection within 90 days or a qualifying drug-resistant infection within 180 days?
• Do you have procedure records, culture results, hospital records, imaging, operative reports, or device-identification evidence?

Schmidt & Clark can review whether the procedure, injury, timing, device evidence, medical records, causation, and applicable filing deadline satisfy the firm’s current case criteria.

What Evidence Should I Preserve?

Request procedure reports, operative records, hospital records, imaging, pathology, blood cultures, microbiology results, susceptibility testing, transfusion records, antibiotic records, and discharge summaries.

Device evidence may include manufacturer and model information, serial numbers, scope-tracking logs, reprocessing records, repair history, incident reports, and any recovered broken component.

Do I Have an Olympus Scope Lawsuit?

If you or a loved one suffered a qualifying serious injury after an endoscopic procedure performed from 2018 to the present, 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
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, surgery, blood transfusions, infection treatment, antibiotics, rehabilitation, follow-up care, and future medical expenses supported by an individual case.

Additional damages may include lost wages, diminished earning capacity, pain and suffering, disability, long-term complications, and wrongful-death damages where permitted by 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, date, injury, Olympus device information, hospitalization, diagnosis, and available evidence.

Investigation. Attorneys may review medical records, device-tracking data, scope information, reprocessing records, component evidence, 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 device-design information, maintenance records, reprocessing materials, medical evidence, microbiology data, and expert 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 case may warrant review if you underwent a qualifying procedure from 2018 to the present and suffered an injury meeting Schmidt & Clark’s current screening criteria. Eligibility also depends on causation, evidence, damages, and applicable law.

What Evidence May Support an Olympus Scope Lawsuit?

Useful evidence can include procedure reports, scope-identification records, cultures, hospital records, imaging, transfusion records, operative reports, reprocessing logs, and recovered device components.

Which Endoscopic Procedures Currently Qualify for Screening?

Current Schmidt & Clark criteria include laparoscopy, colonoscopy, ERCP, bronchoscopy, upper endoscopy, ureteroscopy, hysteroscopy, sinus endoscopy, and cystoscopy performed from 2018 to the present.

What Infections Meet the Current Screening Criteria?

The criteria include sepsis or bacteremia and certain bacterial, pulmonary, tuberculosis, HIV, and drug-resistant infections when applicable timing and treatment requirements are met. The criteria are used for case screening and do not prove scope-related transmission.

What Is the 90-Day Infection Requirement?

A bacterial infection requiring hospitalization, severe pulmonary infection, pneumonia, tuberculosis, or HIV currently meets the timing screen when diagnosed within 90 days of a qualifying procedure. Medical causation still requires separate evaluation.

What Is the 180-Day Drug-Resistant Infection Requirement?

A qualifying drug-resistant infection such as CRE or resistant E. coli may meet the current screening window when diagnosed within 180 days. Culture and antimicrobial-susceptibility results can be important evidence.

Can Perforation or a Broken Endoscope Component Qualify?

Potentially. Organ or tissue injury, perforation, and a broken or dislodged endoscopic component are included in current screening when the injury is medically documented and linked to the procedure.

How Can I Determine Which Scope Was Used?

Ask the medical facility for complete procedure records and device-tracking information. These records may identify the manufacturer, model, serial number, accessories, and reprocessing history.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220844
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=218481
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=216332
4. 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
5. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes
6. https://www.cohenmilstein.com/case-study/olympus-scope-litigation/