Olympus Issues Worldwide Safety Alert After 2 Patient Deaths from Contaminated Scopes

In an Urgent Field Safety Notice issued October 17, 2025, Olympus Corporation disclosed that two patients have died and five others have suffered serious injuries from infections linked to its TJF-Q190V, TJF-Q290V, and TJF-Q170V duodenoscopes — flexible medical devices used in tens of thousands of U.S. ERCP procedures each year [1]. The casualties occurred between 2024 and 2025.

The alert instructed hospitals worldwide to inspect every affected scope's distal tip under 10x magnification, because surface defects capable of trapping bacteria are too small to be seen with the naked eye. Routine cleaning protocols, Olympus acknowledged, cannot reliably remove contamination once it takes hold inside the device's tiny elevator mechanism.

The October notice followed an earlier blow to the company. On June 24, 2025, the U.S. Food and Drug Administration imposed Import Alert 89-04, blocking entry of bronchoscopes, laparoscopes, ureterorenoscopes, and automated endoscope reprocessors made at Olympus' Aizu facility in Fukushima, Japan [2]. The FDA cited "outstanding Quality System regulation violations."

These developments have reopened a wave of patient and family lawsuits that began nearly a decade ago, when contaminated Olympus duodenoscopes were tied to outbreaks at major U.S. hospitals. Virginia Mason Medical Center in Seattle saw at least 32 patients infected with antibiotic-resistant E. coli between 2012 and 2014, with 11 deaths attributable to the infection [3]. UCLA's Ronald Reagan Medical Center confirmed in February 2015 that 179 patients had been exposed to CRE — a "superbug" resistant to last-resort antibiotics — through Olympus duodenoscopes; seven were infected and two died [4].

Olympus has already faced significant legal consequences. In December 2018, Olympus Medical Systems Corp. pleaded guilty in U.S. federal court to three counts of distributing misbranded medical devices and paid $85 million in fines and forfeiture for failing to report European outbreaks involving roughly 30 patients infected with E. coli and drug-resistant Pseudomonas [5]. Pentax Medical later paid $43 million in 2020 under a deferred prosecution agreement to resolve a parallel federal investigation into its own duodenoscope line [6].

A 2017 Seattle jury ordered Olympus to pay $6.6 million on a failure-to-warn claim brought by Virginia Mason Medical Center and the family of patient Richard Bigler, with the hospital itself also held partly negligent. Most patient and family settlements since have been resolved confidentially.

The 2025 disclosures give plaintiff attorneys new evidence in a litigation that has been quietly active since the original outbreaks. While there is no consolidated multidistrict litigation as of 2026, individual product-liability and wrongful-death suits continue to be filed in state and federal courts. Patients who developed serious infections within roughly 30 days of a colonoscopy, ERCP, or other endoscopic procedure may have grounds for a claim — particularly where cultures grew CRE, drug-resistant E. coli, Klebsiella, or Pseudomonas.

Learn more about your legal options for a colonoscopy or endoscopy infection lawsuit.

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Sources

1. Olympus Corporation, Urgent Field Safety Notice, October 17, 2025.
2. U.S. Food and Drug Administration, "Import Alerts for Certain Olympus Medical Devices Manufactured in Japan — Letter to Health Care Providers," June 24, 2025.
3. Modern Healthcare, "Endoscope infections at Virginia Mason prompt broader safety fears," 2015.
4. UCLA Health, "UCLA statement on notification of patients regarding endoscopic procedures," February 18, 2015.
5. U.S. Department of Justice, "Olympus Medical Systems Corporation and Former Senior Executive Plead Guilty to Distributing Misbranded Medical Devices," December 10, 2018.
6. U.S. Department of Justice, "Pentax Medical Company Agrees to Pay $43 Million to Resolve Criminal Investigation," 2020.

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Related Case

Colonoscopy & Endoscopy Infection Lawsuit

These Olympus duodenoscope deaths are the latest chapter in a long pattern of contaminated-scope infections that endoscopy and colonoscopy patients have pursued legal claims over.