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

Patients, including the Bigler family, allege that hard-to-clean Olympus duodenoscopes caused serious infections after procedures such as ERCP. The FDA has posted three Class 2 recalls of Olympus scopes and related devices since November 2025. The FDA also lists two Class I bronchoscope recalls from 2023. No MDL is pending for Olympus scopes. The best-known case, Bigler v. Olympus, went to trial in Seattle in 2017, and a judge later ordered a new trial. In 2018, the maker of these scopes pleaded guilty to three federal charges. Olympus Medical Systems Corporation had failed to report infections tied to one of its duodenoscopes.

Latest Olympus Scope Lawsuit Updates

July 7, 2026: FDA Posts Class 2 Recall of Distal Cover

On July 7, 2026, the FDA posted a Class 2 recall of the MAJ-2315 single-use distal cover. The cover is used with the TJF-Q190V duodenovideoscope [1]. Olympus started the recall on June 5, 2026 (Z-2676-2026). It covers 988,700 units. The company released a new design to replace the old cover. The FDA names device design as the cause.

March 20, 2026: FDA Posts Class 2 Recall of Endoscope Reprocessor

Class 2 recall Z-1612-2026 of the OER-Elite endoscope reprocessor was posted by the FDA on March 20, 2026. It covers 2,929 units. The cause, says the FDA, is reprocessing controls [2]. Olympus told consignees on about February 12, 2026 to immediately cease reprocessing the MAJ-1443 and MAJ-1444 valves in an OER-Pro or OER-Elite.

November 21, 2025: FDA Posts Class 2 Recall of TJF-Q190V Duodenoscope

The FDA’s Class 2 recall of the EVIS EXERA III TJF-Q190V duodenoscope (Z-0579-2026) was posted on November 21, 2025. It covers 7,023 units with all serial numbers [3]. Olympus gave continued reports of positive cultures and infections as the reason, which led to updated reprocessing materials. Olympus Corporation of the Americas sent correction letters on October 14, 2025 that asked facilities to complete training.

June 24, 2025: FDA Letter Explains Import Alerts on Olympus Devices

On June 24, 2025, the FDA wrote to health care providers about import alerts. The alerts cover certain devices made in Japan by Olympus Medical Systems Corporation and its subsidiaries [4]. The FDA cited Quality System regulation violations still outstanding. The alerts apply to devices made at the Aizu site, including ureterorenoscopes, bronchoscopes, laparoscopes and endoscope reprocessors. Devices in use may stay in use if no problems occur.

October 12, 2023: Olympus Starts Class I Recall of Bronchoscopes

Olympus started an expanded Class I recall of bronchofiberscopes and bronchovideoscopes on October 12, 2023. The FDA says using them with high-frequency therapy while supplying oxygen may lead to fires and burns [5]. The recall covers 17,691 devices in the United States, distributed from January 1, 2001 to September 11, 2023. Customers with questions can call Olympus at 1-800-848-9024, option 1.

June 8, 2023: Olympus Starts Class I Recall of Laser-Compatible Bronchoscopes

Olympus started a Class I recall of laser-compatible bronchoscopes on June 8, 2023. The notice cites reports of burns inside the airways and lungs [6]. The FDA calls Class I the most serious type of recall. Olympus reported three patient injuries including one patient death. The recall covers 15,586 devices distributed from January 20, 1999 to May 3, 2023.

June 30, 2022: FDA Posts Final Results of Duodenoscope Study

On June 30, 2022, the FDA posted the final results of a sampling study by Fujifilm of its newer duodenoscope. The FDA concluded newer models can reduce infection risk compared with older fixed endcap models. The FDA also says Olympus withdrew its fixed endcap duodenoscopes. In that study, only 1.1% of samples tested positive with high concern organisms, against 4 to 6% for similar older models.

December 10, 2018: Olympus Pleads Guilty to Federal Charges

The Justice Department announced that Olympus Medical Systems Corporation pleaded guilty in Newark federal court. The plea covered three counts of distributing misbranded duodenoscopes [7]. The charges involved the TJF-Q180V duodenoscope. Judge Stanley R. Chesler imposed an $80,000,000 fine and a $5,000,000 forfeiture.

January 16, 2018: Judge Orders New Trial in Bigler Wrongful-Death Case

KFF Health News reported that King County Superior Court Judge Steve Rosen ordered a new trial on January 16, 2018. The case is a wrongful-death suit over a patient’s death in 2013 [8]. The judge cited willful discovery violations and ordered Olympus to pay the Bigler family a $250,000 sanction. Olympus said it believed it complied with the Washington discovery rules.

What Is a Duodenoscope?

Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the small intestine. Doctors use them in ERCP to treat pancreas and bile duct problems, says the FDA page Infections Associated with Reprocessed Duodenoscopes [9]. Duodenoscopes are complex and have many small working parts. If not thoroughly cleaned and disinfected, tissue or fluid from one patient can remain for the next patient. In rare cases, this can transmit infection.

Who May Be Affected?

People who had ERCP and later got an infection may be affected. So may people whose procedure used one of these devices:

• A TJF-Q190V duodenoscope, since the FDA recall covers all serial numbers
• A TJF-Q180V duodenoscope that a provider received between August 2012 and October 2014, a provider group the 2018 plea says Olympus must notify
• A bronchoscope used with high-frequency therapy, lasers or argon plasma coagulation, which can cause airway burns

A procedure alone does not show that a scope caused harm, so each claim needs an individual legal review. Related scope claims are on our endoscopic procedures lawsuit page.

Reported Injuries or Damages

In the Bigler suit, Theresa Bigler claimed a tainted Olympus scope caused the infection that led to her husband’s death in 2013. Richard Bigler was 57 and was being treated for pancreatic cancer. The FDA’s duodenoscope page says the CDC alerted the FDA in fall 2013. The alert pointed to a possible association between multi-drug resistant bacteria and duodenoscopes. Infections occurred even when users followed the maker’s cleaning and disinfection instructions. The FDA knows of seven medical device reports of thermal injuries tied to the October 2023 bronchoscope recall. It lists airway burns, bleeding, apnea and death as possible harm. The 2018 plea covered three events in Europe in 2012, all tied to the TJF-Q180V. In the Netherlands, about 22 patients had Pseudomonas aeruginosa infections. In France, three patients had Escherichia coli infections at Clinique de Bercy and five had Pseudomonas aeruginosa at Kremlin Bicetre.

Recall and Regulatory Background

The FDA lists all three Class 2 recalls from 2025 and 2026 as open. For the 2023 bronchoscope recalls, the FDA says the action is a correction and not a product removal. On April 5, 2022, the FDA closed its Warning Letters to all three duodenoscope makers, including Fujifilm and Olympus. The letters were about postmarket surveillance studies. A recall does not establish liability. As of August 3, 2026, the Judicial Panel on Multidistrict Litigation has no MDL pending for Olympus scopes or other endoscopes [10].

Evidence to Preserve

These records may help a lawyer review a possible claim:

• The date and place of each procedure, with the report and discharge papers
• Culture results and the infection diagnosis from your doctors
• The scope model and serial number from the facility’s cleaning or repair records, if it gives them to you
• Medical bills and insurance statements for care after the procedure
• Photos of any injury, taken as soon as you can after it appears
• Letters or notices from the hospital or the maker about the scope
• Emails and messages with your doctors about the procedure or your recovery
• The names of the doctors and staff who handled your care

Filing Deadlines

State law sets the time limit for filing a medical device injury claim. Once the filing period runs out, a strong claim can still be lost. How long you have can depend on where you live, when the infection or injury occurred, and when a doctor diagnosed it. Talk to a lawyer promptly if you think a deadline may apply to you.

Potential Compensation

If a claim succeeds, damages can include medical expenses, lost income, pain and suffering and loss of enjoyment of life. In a wrongful-death claim, funeral costs and loss of support can also be sought. In 2017, Bigler jurors found the TJF-Q180V design not unsafe. They ordered Olympus to pay Virginia Mason Medical Center $6.6 million, and the hospital had to pay the family $1 million. A new trial was later ordered. Compensation amounts vary by case. Past results do not guarantee future outcomes. Potential compensation also depends on the facts of each case.

Frequently Asked Questions

Can a Duodenoscope Cause an Infection?

Yes, a duodenoscope can cause an infection, according to the FDA. The FDA also says the overwhelming proportion of procedures with these devices are carried out safely and effectively. It takes the risk of infection very seriously.

What Does the Research Say About Duodenoscope Infections?

Research on duodenoscope infections includes FDA postmarket studies. In December 2018, interim results showed higher than expected contamination after reprocessing. In August 2019, the FDA recommended designs that ease or end reprocessing.

What Did Olympus Plead Guilty to in 2018?

Olympus’s 2018 guilty plea covered misbranded duodenoscopes. The Justice Department said Olympus shipped hundreds in the United States. That brought about $40 million in revenue and $33 million in gross profit. Its $85 million payment was over 2½ times that profit.

How Many Deaths Have Been Tied to Olympus Duodenoscopes?

Deaths tied to Olympus duodenoscopes number at least 35, KFF Health News reported in January 2018. The patients died in American hospitals since 2013 after infections. Richard Bigler was one of them. That figure is a news count. It is not an agency finding.

Did an Olympus Executive Also Plead Guilty?

Yes, a former Olympus executive also pleaded guilty in the same Justice Department case. Hisao Yabe pleaded to one count. Olympus also agreed to reforms. An independent expert reviews its adverse event reports for three years.

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/res.cfm?id=218481
3. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=216332
4. https://www.fda.gov/medical-devices/letters-health-care-providers/import-alerts-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers
5. https://www.fda.gov/medical-devices/medical-device-recalls/olympus-corporation-americas-recalls-bronchofiberscopes-and-bronchovideoscopes-because-they-can-lead
6. https://www.fda.gov/medical-devices/medical-device-recalls/olympus-corporation-americas-recalls-laser-compatible-olympus-bronchoscopes-risk-endobronchial
7. https://web.archive.org/web/20250422122658/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
8. https://kffhealthnews.org/courts/olympus-faces-new-trial-over-medical-scopes-tied-to-superbug-deaths/
9. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes
10. https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-August-3-2026.pdf