Medical Scope Infection: Timeline of Key Events
Reviewed by Jacobs Kolton, Chtd. Attorneys at Law; Updated May 2026
Reusable medical scopes, such as endoscopes and duodenoscopes, are widely used in procedures such as ERCP, colonoscopy, bronchoscopy, gastroscopy, and upper endoscopy. These devices allow doctors to diagnose and treat serious medical conditions without open surgery, but some reusable scopes have raised infection-control concerns because they can be difficult to fully clean and disinfect between patients.
Over the past decade, federal regulators, hospitals, researchers, and public health agencies have reported concerns involving contaminated endoscopes, duodenoscope reprocessing, antibiotic-resistant infections, and possible patient exposure to dangerous bacteria. Duodenoscopes have received particular attention because of their use in ERCP procedures and their complex design features, including small channels and elevator mechanisms that may make reprocessing more difficult.
The timeline below summarizes medical scope infection warnings, developments, safety communications, recalls, and regulatory actions.
Why Endoscope Infection Warnings Matter
Endoscopes and duodenoscopes are reusable medical devices. After each procedure, they must be carefully cleaned, disinfected, or sterilized before being used on another patient. If bacteria, tissue, fluid, or biofilm remain inside the scope after reprocessing, later patients may be exposed to harmful pathogens.
Infection concerns have been especially significant for duodenoscopes, which are commonly used during endoscopic retrograde cholangiopancreatography (ERCP). Duodenoscopes have intricate parts and hard-to-reach areas that can make complete cleaning difficult. Reported infection concerns have included CRE, E. coli, Klebsiella, Pseudomonas, MRSA, sepsis, cholangitis, bloodstream infection, and other serious complications.
Endoscope Infection Timeline: Overview
- (2013): CDC Alerts FDA to Possible Infection Link.
- (2015): UCLA and Los Angeles CRE Outbreaks.
- (2015): FDA Devices Panel Convenes About Scope Cleaning.
- (2015): FDA Issues Safety Communication About Scope Design
- (2015): FDA Issues Safety Communication on Scope Reprocessing.
- (2015): FDA Orders Studies On Duodenoscope Reprocessing.
- (2016): Senate Investigation Finds Oversight Problems Re: Devices.
- (2017): FDA Publishes Duodenoscope Sampling/Culturing Protocols.
- (2018): FDA Issues Warning Letters Over Failure to Provide Data.
- (2018): Olympus Pleads Guilty Over Failure to Report Infections.
- (2018): FDA Finds Higher Than Expected Contamination Rates
- (2019): FDA Recommends Disposable Scopes To Reduce Infections.
- (2019): FDA Devices Advisory Committee Convenes Re: Scopes.
- (2020): Research Continues Re: Reprocessing and Outbreak Risks.
- (2022): FDA Issues Safety Communication Re: Disposable Scopes.
- (2023): FDA Issues Warning Letters to Olympus.
- (2025): FDA Issues Import Alerts for Certain Olympus Devices
- (2025): FDA Recall Re: Certain Olympus Duodenoscopes.
(2013): CDC Alerts FDA to Possible Infection Link.
In fall 2013, the CDC alerted the FDA to a possible association between multidrug-resistant bacterial infections and duodenoscopes. FDA later reported that infections occurred even when facilities followed manufacturer cleaning and disinfection or sterilization instructions.
(2015): UCLA and Los Angeles CRE Outbreaks.
In February 2015, UCLA Health notified 179 patients that they may have been exposed to a “superbug” (carbapenem resistant Enterobacteriaceae CRE bacteria) during complex endoscopic procedures performed between October 2014 and January 2015 at Ronald Reagan UCLA Medical Center. According to reports, an internal UCLA investigation determined that CRE may have been transmitted by two of the seven Olympus scopes used by the hospital during the 4-month period.
(2015): FDA Devices Panel Convenes.
On May 14 and 15 of 2015, the FDA convened the Gastroenterology-Urology Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes based on available scientific information. Meeting participants stressed the importance that duodenoscopes be designed to enable meticulous cleaning and disinfection or sterilization and urged industry to design duodenoscopes that enable thorough cleaning and effective reprocessing through device disassembly or disposable parts.
(2015): FDA Issues Safety Communication That Duodenoscope Design May Impede Effective Cleaning.
On February 19, 2015, the FDA issued a Safety Communication warning health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. According to the FDA, recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly.
(2015): FDA Issues Safety Communications on Duodenoscope Reprocessing.
In August 2015, following high-profile outbreaks of “superbugs” (CRE) at UCLA and other medical centers, the FDA issued a safety communication explaining that endoscopes used in ERCP procedures can transmit infections if they are not completely cleaned and disinfected and that, because of their unique and complex design, they can be difficult to reprocess.
According to the FDA, duodenoscopes can contain small working parts, including moving parts of an elevator mechanism that contain microscopic, hard-to-reach crevices, that if not thoroughly cleaned and disinfected, can cause tissue or fluid and residual bacteria from one patient to remain in the device, exposing subsequent patients to risk of infection.
The FDA emphasized that facilities should continue to follow the manufacturer’s reprocessing instructions carefully, but said additional steps may be needed to further reduce infection risk, including additional reprocessing measures for duodenoscopes such as microbiological culturing, ethylene oxide sterilization, liquid chemical sterilant processing, or repeat high-level disinfection to reduce the risk of transmitting infections between patients.
(2015): FDA Orders Studies On Duodenoscope Reprocessing.
On October 5, 2015, the FDA ordered U.S. duodenoscope manufacturers (Olympus, Fujifilm and Pentax) to conduct postmarket surveillance studies (“522 study”) to understand how the devices are reprocessed in real-world settings and resulting contamination rates.
(2016): Senate Investigation Finds Broader Oversight Problems.
A U.S. Senate investigation released in 2016 found that duodenoscope-related infections were not isolated events and raised concerns about manufacturer reporting, hospital awareness, and FDA oversight of reusable medical devices. The investigation helped frame the issue as a systemic patient-safety problem involving manufacturers, regulators, and health care facilities.
(2017): FDA Publishes Duodenoscope Sampling and Culturing Protocols.
In 2017, the FDA released protocols for duodenoscope surveillance sampling and culturing designed to help health care facilities detect bacterial contamination and evaluate whether their reprocessing practices were effectively reducing infection risk.
(2018): FDA Issues Warning Letters Over Failure to Provide Data.
On March 9, 2018, the FDA issued Warning Letters to all three manufacturers who make duodenoscopes sold in the U.S. (Fujifilm Medical Systems USA, Inc., Olympus Medical Systems Corporation, and Pentax of America) for failure to provide sufficient data to address the post market surveillance studies requirements under Section 522 of the Federal Food, Drug, and Cosmetic Act (the Act). All three manufacturers responded to the warning letters and submitted plans that outlined how study milestones would be achieved including enrolling new sites and collecting samples.
(2018): Olympus Pleads Guilty Over Failure to Report Serious Infections.
In December 2018, the U.S. Department of Justice announced that Olympus Medical Systems Corporation pleaded guilty to distributing endoscopes after failing to file FDA-required adverse event reports involving serious infections connected to duodenoscopes. DOJ said Olympus agreed to pay $80 million in criminal penalties and $5 million in criminal forfeiture.
(2018): FDA Safety Communication Reports Higher Than Expected Contamination Rates For Duodenoscopes.
The FDA issued a Safety Communication to provide interim results from the ongoing mandated post market surveillance studies of duodenoscopes reprocessing. Interim results from the ongoing post market surveillance studies indicate higher than expected contamination rates after duodenoscope reprocessing.
According to the FDA, up to 3% of properly collected samples tested positive for enough low concern organisms to indicate a reprocessing failure and up to 3% of properly collected samples tested positive for high concern organisms (organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa).
(2019): FDA Recommends Disposable Duodenoscopes To Reduce Risk of Infection.
In August 2019, the FDA issued a Safety Communication to recommend hospitals and endoscopy facilities transition to duodenoscopes with disposable components, such as disposable endcaps, or to fully disposable duodenoscopes, to reduce infection risk linked to reprocessing reusable scopes.
The FDA stated, “Device design is a key factor that contributes to reprocessing challenges. The FDA believes the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary. For example, duodenoscopes that incorporate disposable components can facilitate cleaning, reduce contamination and reduce disease transmission following reprocessing. Disposable designs may reduce between-patient duodenoscope contamination by half as compared to reusable, or fixed endcaps.”
(2019): FDA Devices Advisory Committee Convenes.
On November 6 and 7, 2019, the FDA convened a meeting of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes based on available scientific information.
(2020): Research Continues to Document Reprocessing and Outbreak Risks.
A 2020 peer-reviewed review in Antimicrobial Resistance & Infection Control discussed duodenoscope-associated infection prevention and noted that outbreaks linked to contaminated duodenoscopes continued to influence FDA recommendations and infection-control practices.
(2022): FDA Issues Safety Communication Supporting Disposable Scopes As Solution To Higher Than Expected Contamination Rates of Scopes.
On April 5, 2022, the FDA issued a Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as new information on completed postmarket surveillance studies.
According to the FDA, emerging data suggests that the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary. Duodenoscopes that incorporate disposable components can facilitate cleaning, reduce contamination, and reduce disease transmission following reprocessing. Disposable designs may reduce between-patient duodenoscope contamination by half or more as compared to reusable, or fixed endcaps.
The FDA also warned that the final results of the postmarket surveillance studies on fixed endcap design indicate that “as high as 6.6% of samples tested positive with high concern organisms after contamination. The FDA indicated that Pentax and Olympus were withdrawing their fixed endcap duodenoscopes from the market, and that Fujifilm had completed withdrawal of its fixed endcap duodenoscope.
(2023): FDA Issues Warning Letters to Olympus.
In 2023, FDA issued warning letters to Olympus-related entities concerning alleged violations tied to medical device reporting (MDR) requirements and quality system regulations for endoscopes and endoscope accessories. FDA specifically noted that these reusable devices require cleaning and high-level disinfection or sterilization before reuse. The FDA explained that for reprocessed devices, like those subject to the warning letters, adequate MDR reporting is necessary to ensure that any infections or reprocessing failures associated with these devices are appropriately communicated to and evaluated by the FDA’s Center for Devices and Radiological Health (CDRH) to assure appropriate actions are taken to prevent potential patient injury.
According to the FDA, compliance with quality system requirements for endoscopes is necessary to ensure these devices are designed, validated, and manufactured in a manner that allows for their safe and effective use, including completion of acceptable reprocessing validation and adequate instructions for use.
(2025): FDA Issues Import Alerts for Certain Olympus Medical Devices.
On June 24, 2025, the FDA issued import alerts for certain Olympus medical devices manufactured in Japan, including certain bronchoscopes, ureterorenoscopes, laparoscopes, and automated endoscope reprocessors. The FDA said the alerts allow the agency to detain covered devices at the border and stated that the action followed unresolved “concerns related to outstanding Quality System regulation violations by Olympus” after prior FDA warning letters. Although the import alerts were not described as being specific to infection concerns, the affected products included reusable scope-related devices and automated endoscope re-processors, making the action relevant to ongoing device safety and reprocessing concerns.
(2025): FDA Recall Record Notes Continued Positive Cultures and Infections for Olympus Duodenoscopes.
An FDA recall record dated November 21, 2025, for Olympus EVIS EXERA III duodenovideoscopes states that “continued reports of positive cultures and infections” led Olympus to update reprocessing materials intended to minimize potential deviations in TJF duodenoscope reprocessing. The FDA recall record lists the determined cause as device design.
(2026): Law Firms Begin Investigating Olympus Medical Scope Infection Claims
In 2026, product liability lawyers and mass tort law firms began investigating potential claims on behalf of patients who developed serious infections after procedures involving Olympus endoscopes, duodenoscopes, bronchoscopes, colonoscopes, or other reusable medical scopes. These Olympus endoscope infection lawsuit investigations focus on whether contaminated scopes, reprocessing failures, device design issues, or inadequate warnings may have contributed to post-procedure infections.
Attorneys reviewing these cases may look at the type of scope procedure performed, the date of the procedure, the infection diagnosed, lab culture results, hospitalization records, antibiotic treatment, ICU admission, organ damage, sepsis, or wrongful death. Claims involving ERCP procedures and Olympus duodenoscopes may receive particular attention because duodenoscopes have been the subject of prior FDA warnings, contamination concerns, and regulatory actions.
If you (or a loved one) were injured or suffered complications after having a colonoscopy, ERCP, bronchoscopy, endoscopy or other procedure involving an endoscope or duodenoscope, you may be entitled to recover compensation from an Olympus medical scope infection lawsuit case or settlement claim. Contact a medical device injury lawyer to request a free case review.
*If you or a loved one are experiencing health issues, side effects or complications from a medical device or healthcare product, we urge you to promptly consult with your doctor or physician for an evaluation.
**The listing of a company (e.g., Olympus America, Inc., Olympus Corporation of the Americas, Olympus Medical Systems Corp. etc.) or product (e.g., Olympus endoscope or duodenoscope, etc.) is not meant to state or imply that the company acted illegally or improperly or that the product is unsafe or defective; rather only that an investigation may be, is or was being conducted to determine whether legal rights have been violated.
***The use of any trademarks, tradenames or service marks is solely for product identification and/or informational purposes.
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