Olympus Endoscope Recalls and FDA Warnings: What Patients Should Know

In May 2025, Olympus sent a notice to health care facilities about its TJF-Q190V duodenoscope. 

The issue? Postmarket data showed higher levels of microbial contamination with manual cleaning of the duodenoscope beyond 1 hour and performing a presoak, compared to manual cleaning within 1 hour. 

Delays in cleaning the duodenoscope, or the inability of health care personnel to consistently perform reprocessing of the duodenoscope within the prescribed time limits, resulted in higher levels of microbial contamination. 

Olympus informed health care personnel of the inadequacies of manual cleaning and the need to strictly adhere to the instructions for reprocessing of its duodenoscopes.

A few months later, Olympus issued a correction to this notice. This time, the company said it had received continued reports of positive cultures and infections associated with its TJF-Q190V duodenoscope.

Some medical devices have been the subject of FDA warnings because of their design and the inability to consistently remove microbial contamination from complex medical devices. The focus of more recent Olympus device corrections has been on endoscope accessories.

If medical equipment is risky by design, it should never have been made available to health care providers in the first place.

If you or a loved one have experienced adverse health effects after being treated with Olympus endoscopes and/or accessories, contact Morgan & Morgan for a free case evaluation to learn more about whether a contaminated device contributed to an illness and whether the resulting injuries could support a lawsuit.

Reasons for FDA interest in Endoscope Contamination

Some components of endoscopes help physicians access hard to reach areas of the body. These components, however, also create pathways for biological residue to remain on the endoscope after use.

The FDA has focused on the kind of endoscope used during ERCP (Endoscopic Retrograde CholangioPancreatography) procedures to investigate and treat disorders of the bile ducts and pancreas.

In 2013, The Centers for Disease Control and Prevention (CDC) notified the FDA about potential concerns of multidrug-resistant infections and Duodenoscopes.

Investigations by the FDA and other agencies confirmed contamination and indicated there was little assurance the problem would be resolved by following manufacturer’s directions for cleaning and disinfecting the duodenoscopes.

Consequently, regulators became interested in how to make endoscopes safer to clean and reprocess, to what extent reprocessing was effective, and what could be done to better design duodenoscopes to address access challenges.

Regulatory History and Actions

The length of the history and various generations of impacted devices stretches over multiple years.

2018: FDA Duodenoscope Surveillance Warning Letters

In 2018, the FDA sent warning letters to Olympus, Fujifilm, and Pentax for inadequate submissions of required postmarket surveillance studies to help the FDA understand the safety of duodenoscopes after they enter clinical practice. The FDA emphasized in the letters that the companies had not complied with the surveillance requirements, rather than that every device they manufactured was contaminated. In April 2022, the FDA reported the warning letters had been closed.

2019: Transition Away From Fixed-Endcap Duodenoscopes

In August 2019, the FDA asked hospitals and endoscopy facilities to transition to duodenoscopes designed to make cleaning easier or eliminate certain reprocessing requirements.

Some older fixed-endcap designs had challenges because their design could limit access to areas that may contain contamination.

As a result, the manufacturers of those fixed-endcap devices have begun removing them from the market.

The FDA has said that it continues to support designs of endoscopes that may eliminate the need for certain reprocessing, including instruments with disposable components.

2025: Olympus TJF-Q190V Reprocessing Corrections

The TJF-Q190V duodenoscope was the focus of additional regulatory action in 2025.

In May 2025, Olympus released a medical device correction to provide updated cleaning instructions. Surveillance data indicated that use of a presoak in conjunction with delayed manual cleaning may result in increased levels of contamination.

In October 2025, Olympus released a medical device correction to provide updated reprocessing instructions and recommendations to address continued reports of positive cultures and infections.

Due to the nature of these corrections, it is important to identify the specific equipment used to perform a patient’s procedure, as opposed to describing equipment generally as an Olympus endoscope.

Olympus Endoscope Accessories Also Raise Infection Concerns

The accessories, valves, and reprocessing equipment used with an endoscope may also create additional infection risks.

December 2024: Olympus MAJ-891 Forceps/Irrigation Plug Recall

Olympus began recalling its MAJ-891 Forceps/Irrigation Plugs in December 2024. The public recall was initiated in January 2025.

This accessory was used with Olympus cystoscopes, ureteroscopes, choledochoscopes, and hysteroscopes.

Contamination of the accessory could cause patients to contract urinary tract infections or sepsis, according to the FDA. Olympus has reported to the FDA 120 injury incidents and 1 death caused by infections associated with the use of the MAJ-891 accessory with a cystoscope.

Olympus has recommended alternate products and emphasized proper disconnection and disassembly of the accessory prior to reprocessing.

February 2026: Corrections Involving Endoscope Reprocessors and Valves

A corrections program initiated by Olympus in February 2026, addressed suction valves and endoscope reprocessors.

MAJ-1443 and MAJ-1444 valves used with Olympus OER-Pro and OER-Elite automated endoscope reprocessors were affected by the corrections program.

Affected users were directed to immediately stop using the affected combinations and follow updated reprocessing instructions.

The FDA classified the corrections as a Class II recall in March 2026.

June 2026: Recall of Olympus MAJ-2315 Distal Cover

A correction initiated by Olympus on June 5, 2026, addressed a previous design of its MAJ-2315 single use distal cover, used with the TJF-Q190V duodenovideoscope.

This Class II recall was posted by the FDA on July 7, 2026. Olympus informed affected customers to transition to a newly designed cover and return the previously supplied cover.

This action was taken for a certain accessory design. It does not determine that all Olympus duodenoscopes, or all procedures involving the MAJ-2315, resulted in contamination or patient injury.

Does a Recall Mean an Olympus Duodenoscope Caused an Infection?

A recall does not, by itself, define what occurred during a procedure.

Product recalls can occur for a number of reasons such as the need to update or alter instructions, training, or software, and/or for the removal or replacement of a product.

A patient, in general, must show that a piece of medical equipment used in a procedure was defective or that some other actionable failure occurred, and that such a failure caused the patient's injury. This can be confirmed through a combination of records, laboratory findings, equipment, and expert opinion.

Evidence of a recall can be pertinent to a case, but the legal impact of the evidence will depend on the equipment, the alleged failure, the law, and when the injury occurred.

What Should Patients Do if Equipment Used in their Procedure is Recalled?

The FDA recommends that if patients receive a notification regarding contaminated equipment, they should seek medical attention if they are having any symptoms.

Those who have contracted a serious infection should request their procedure records and any records that indicate the equipment that was used in their procedure.

An attorney at Morgan & Morgan could look into whether the instrument was subject to an FDA safety action. The attorney could also examine whether the proper warnings and instructions were given. The attorney may find evidence showing the device could have been the source of the infection.

Morgan & Morgan is currently investigating these cases. To see if you are eligible to file a lawsuit, contact Morgan & Morgan for a free case evaluation.

Frequently Asked Questions

Which Olympus endoscopes have been recalled?

Olympus recalls and medical device corrections have involved different products over time, including the TJF-Q190V duodenovideoscope, certain accessories, and automated reprocessing equipment.

The underlying issues vary. Some involve changes to cleaning instructions, while others address accessory design or compatibility with reprocessing equipment.

Patients should identify the specific instrument and any relevant accessories used during their procedure before determining whether an FDA action applies. A general reference to an Olympus endoscope may not provide enough information to establish that the device was affected.

What is a Class II medical device recall?

Under the FDA's classification system, a Class II recall generally involves a product whose use or exposure could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

A Class II classification describes the regulatory assessment of the product problem. It does not determine whether an individual patient experienced an injury or has grounds for a lawsuit.

Medical device recalls can also involve corrections to instructions or the way equipment is used, rather than requiring every affected product to be permanently removed from healthcare facilities.

Does an FDA warning prove Olympus was negligent?

An FDA warning or recall may provide important evidence about a device's safety history, but it does not automatically establish negligence or another basis for legal liability.

A legal investigation must consider the specific product, the alleged defect or failure, the information available to the manufacturer, and whether the problem caused the patient's injuries.

Different claims may involve different legal standards. For example, a product liability claim against a manufacturer may raise different issues from a medical malpractice claim concerning a hospital's infection-control practices.

Can I pursue a claim if my procedure happened before the recall?

A recall may be announced after a patient has already undergone a procedure or developed an infection. Whether the earlier injury supports a claim depends on the evidence, the applicable law, and whether the relevant problem existed when the equipment was used.

The timing of the recall may become important when investigating what the manufacturer or healthcare facility knew about a safety concern.

Patients should also be aware that legal filing deadlines vary by state and claim type. Waiting for additional recall announcements could affect their ability to pursue compensation.