Endoscopy Lawsuit

Reusable endoscopes have been subject to multiple recalls due to contamination risks that may cause serious infections and sepsis. Affected patients may be able to seek compensation by filing an endoscopy lawsuit against the device’s manufacturer.

At Sokolove Law, we have over 45 years of experience holding companies accountable for putting patients at risk. Call (800) 995-1212 now.

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Understanding the Endoscope Infection Lawsuit

Endoscopes are reusable medical devices used to examine the inside of the body during procedures. However, lawsuits claim the design of these products may make them difficult to fully disinfect or reprocess before they’re used on another patient.

The U.S. Food and Drug Administration (FDA) has linked reprocessed endoscopes to serious health complications, including antibiotic-resistant “superbugs” and sepsis, leading dozens of families to file endoscope lawsuits.

Learn more about endoscope infection lawsuits: 

  • Over 250 patients have developed carbapenem-resistant Enterobacteriaceae from contaminated endoscopes, a superbug with a 50% survival rate, according to the U.S. Senate Health, Education, Labor, and Pensions Committee.
  • Endoscope lawsuits have been filed against manufacturers like Olympus Medical Systems Corporation, Fujifilm Medical Systems USA, and Pentax of America.
  • Olympus was previously fined more than $85 Million for failing to file adverse-event reports involving infections tied to their duodenoscopes.
  • In one case, a jury ordered Olympus to pay $6.6 Million to a Seattle hospital after a superbug outbreak, with $1 Million to be given to the family of a patient who passed away.
  • Pentax agreed to pay $43 Million to resolve criminal charges involving misbranded endoscopes and failure to file timely reports of infections linked to their devices.

If you developed a serious infection after an endoscopic procedure, you may be able to pursue legal compensation for your medical bills, pain and suffering, lost wages, and more.

At Sokolove Law, we’ve secured over $1.6 Billion for clients harmed by dangerous medical devices and prescription drugs. Let us fight for you.

Our Endoscope Lawyers Are Here for You

We’ve helped thousands of families hold powerful medical device companies accountable. Find out if you may be able to file an Olympus scope lawsuit.

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Endoscope Recall News 2026

The FDA has issued multiple endoscope-related recalls in response to the increased risk of serious infections linked to these devices.

Find out more about the latest endoscope recall news: 

  • March 2026: The FDA announced a Class II device recall for the Olympus OER-Pro endoscope reprocessor after certain valves were found to be incompatible with the system (MAJ-1443 and MAJ-1444), potentially affecting proper cleaning and increasing the risk of contamination.
  • June 2025: The FDA announced a Class II device recall for the Olympus TJF duodenoscope after reports suggested the device could be more prone to bacterial contamination when not cleaned promptly after use, raising concerns about infection risk.
  • February 2025: The FDA issued a Class I recall involving an Olympus endoscope accessory (MAJ-891) due to contamination risks that reportedly caused 120 injuries and 1 death.
  • July 2023: The FDA issued a Class II device recall of an Olympus duodenoscope device (TJFQ190V) after multiple reports of patient infections and contamination.
  • July 2017: Fujifilm issued a voluntary recall and correction for all ED-530XT duodenoscopes after safety concerns that the device’s complex design could hinder effective cleaning.
  • December 2015: The FDA announced a Class II recall of the Fujifilm ED-450XL5 endoscope following reports of multidrug-resistant bacteria associated with certain procedures. The recall involved updated cleaning and disinfection instructions to address contamination risks.

The risks associated with reusable endoscopes have been recognized for over a decade, putting countless patients at risk. However, these devices continue to be marketed and used in hospitals across the country.

Who Qualifies for an Olympus Endoscopy Lawsuit?

To be eligible for an Olympus endoscopy lawsuit, your lawyer must gather evidence showing you developed a serious infection as a result of an endoscopic procedure.

You may qualify for an endoscopy lawsuit if you or a loved one:

  • Underwent an endoscopic procedure within the past 10 years
  • Was diagnosed with sepsis or required IV antibiotics within 30 days of the procedure

Endoscopic procedures can include colonoscopies, upper endoscopies (EGD), endoscopic retrograde cholangiopancreatography (ERCP), duodenoscopies, and other gastrointestinal (GI) scopes.

There’s only a limited amount of time to take legal action for an infection caused by a faulty endoscope, so it’s important to reach out to an attorney as soon as possible.

Call (800) 995-1212 now to see if we may be able to help you seek justice and compensation from an Olympus endoscopy lawsuit.

The Risk of Sepsis After an Endoscopy

Endoscopes are designed with long, narrow channels and small moving parts that can trap tissue, fluid, and bacteria during use. Even after disinfection, harmful bacteria may remain inside the device and be transferred to another patient.

“On average, 19.98 % of reprocessed gastrointestinal endoscopes may be contaminated when used in patients.”
– Endoscopy International Open

Contaminated endoscopes have caused some patients to develop sepsis, a potentially life-threatening condition that occurs when the body has an extreme response to infection.

If you or a loved one develops symptoms of sepsis after an endoscopy, including a fever, rapid heart rate, difficulty breathing, extreme pain, low blood pressure, or confusion, it’s important to contact a doctor right away.

How to File an Olympus Scope Lawsuit

Filing a lawsuit against a major medical device manufacturer can feel overwhelming — but you don’t have to take on these powerful companies alone.

If you have a case, we’ll handle every step of an Olympus scope lawsuit on your behalf, so you can focus on your health.

Our endoscope attorneys can help: 

  • Determine your eligibility to take legal action during a free case review
  • Collect evidence, including medical records, procedure history, and device design plans, to build a strong case on your behalf
  • File your Olympus medical lawsuit in the correct court before any deadlines
  • Negotiate an endoscope settlement with the defendant(s)
  • Take your case to court and seek compensation from a trial verdict, if a settlement is unable to be reached

By filing an endoscope lawsuit against the device’s manufacturer, you may be able to secure compensation for medical bills, lost wages, pain and suffering, and more.

Let Our Endoscope Lawyers Fight for You

At Sokolove Law, our endoscope lawyers can help clients in all 50 states hold negligent medical device companies accountable for the harm they’ve caused.

To date, we’ve secured more than $1.6 Billion in cases involving dangerous medical devices and prescription drugs.

There are no upfront costs or hourly fees to work with our firm. We only get paid if we secure compensation on your behalf.

Call (800) 995-1212 now or fill out our contact form to get started with a free, no-obligation case review. We’re standing by to answer any questions you may have.

Endoscopy Infection Lawsuit FAQs

Can you get sepsis from an endoscopy?

Yes. Patients may be at risk of developing sepsis if an endoscope is contaminated with bacteria that enter the body during a procedure.

Duodenoscopes and other reusable endoscopes have small channels and moving parts that can trap tissue or fluid, making thorough cleaning difficult. If harmful bacteria remain, they can cause infections that sometimes progress to sepsis, a serious and potentially life-threatening condition.

Contact Sokolove Law now to find out if you may be eligible for compensation from an endoscope lawsuit.

Which companies manufacture endoscopes?

Reusable endoscopes are manufactured by Olympus Medical Systems Corporation, Fujifilm Medical Systems USA, Inc, and Pentax of America.

Since 2013, the U.S. Food and Drug Administration has been aware of the risk of infections associated with reprocessed duodenoscopes and has issued warning letters to each of these companies.

Is there an Olympus endoscope recall?

Yes. The FDA has issued multiple recalls for Olympus endoscopes and related devices due to contamination risks that can increase the likelihood of serious infections, including sepsis and antibiotic-resistant “superbugs.”

At this time, there are still active Olympus endoscope recalls, including for the TJF duodenoscope and certain valves, which were found to be incompatible with the reprocessing system and could affect proper cleaning.

Call (800) 995-1212 now if you or a loved one developed sepsis after undergoing an endoscopic procedure. We may be able to file an Olympus duodenoscope lawsuit for compensation.

How much does an endoscope lawsuit attorney cost?

At Sokolove Law, there are no upfront costs or hourly fees to work with our endoscope lawsuit attorneys.

We operate on a contingency-fee basis, which means you pay nothing unless we secure compensation on your behalf.

  1. BioSpace. “Olympus Ordered to Cough Up $6.6 Million in Damages to Seattle Hospital Over Contaminated Scopes.” Retrieved from: https://www.biospace.com/olympus-ordered-to-cough-up-6-6-million-in-damages-to-seattle-hospital-over-contaminated-scopes.
  2. Endoscopy International Open. “Gastrointestinal endoscope contamination rates – elevators are not only to blame: a systematic review and meta-analysis.” Retrieved from: https://pmc.ncbi.nlm.nih.gov/articles/PMC9187382/
  3. Med Tech Dive. “FDA labels recall of discontinued Olympus endoscope part as Class I.” https://www.medtechdive.com/news/Olympus-recall-endoscope-accessory-reprocessing/738963/.
  4. U.S. Food & Drug Administration. “Class 2 Device Recall Duodenovideoscope.” Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=213467.
  5. U.S. Food & Drug Administration. “Class 2 Device Recall Olympus Endoscope Reprocessor OERPro.” Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=218482.
  6. U.S. Food & Drug Administration. “Class 2 Device Recall OLYMPUS TJFQ190V Duodenoscope.” Retrieved from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=202210.
  7. U.S. Food & Drug Administration. “Infections Associated with Reprocessed Duodenoscopes.” Retrieved from: https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes.
  8. U.S. Senate Health, Education, Labor, and Pensions Committee. “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” Retrieved from: https://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf.
  9. U.S. Department of Justice. “Olympus Medical Systems Corporation, Former Senior Executive Admit Distributing Endoscopes after Failing to File FDA-Required Adverse Event Reports of Serious Infections.” Retrieved from: https://www.justice.gov/usao-nj/pr/olympus-medical-systems-corporation-former-senior-executive-admit-distributing-endoscopes.
  10. U.S. Department of Justice. “Pentax Medical Company Agrees to Pay $43 Million to Resolve Criminal Investigation Concerning Misbranded Endoscopes.” Retrieved from: https://www.justice.gov/archives/opa/pr/pentax-medical-company-agrees-pay-43-million-resolve-criminal-investigation-concerning.
  11. U.S. Food & Drug Administration. “Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus.” Retrieved from: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/update-alert-endoscope-accessories-forcepsirrigation-plug-issue-olympus.