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Olympus Scopes: Recalls and Lawsuits

Olympus Scopes: Recalls and Lawsuits

People have been injured by Olympus endoscopes and bronchoscopes. Learn about affected Olympus devices and related recalls and lawsuits.

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A depiction of how a duodenoscope works. The graphic shows the scope lighting the inside of the stomach
Written by: Mike Daly
Last Updated: June 9, 2026

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Case Overview

Olympus has issued Class I recalls of endoscope and bronchoscope products that have harmed people during medical procedures. Some injuries have been serious enough that patients have filed lawsuits. Learn more about the recalls, the harms caused and whether you might be eligible for compensation.

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Important Olympus endoscope recall lawsuit updates

  • November 2025: Olympus updated the instructions for use of its Single Use Ligating Device PolyLoop Model Number HX-400U-30 due to the ligation loop failing to release.
  • October 2025: Olympus Corporation updated the labeling for how to safely use bronchoscopes.
  • September 2025: Olympus recalled ViziShot 2 FLEX (19G) EBUS-TBNA Needles due to a deformity which may cause part of the device to eject into patients’ airways.
  • June 2025: FDA issued an import alert, blocking numerous Olympus products from importation into the United States from its Japanese manufacturing facilities.
  • February 2025: Olympus recalls certain models of Single Use Guide Sheath Kits after receiving complaints that the radiopaque tip of the guide sheath component was breaking off into patients.
  • January 2025: Olympus announced a voluntary advisory notice and Class 1 recall for its endoscope accessory, the Forceps/Irrigation Plug (Isolated Type) model MAJ-891, because of the risk of infection and contamination.
  • October 2023: Olympus updated the labeling of its laser-compatible bronchoscopes to provide instructions to avoid injuries to patients
  • March 2016: Olympus paid a record $646 million settlement for criminal and civil complaints pertaining to violations of the False Claims Act and Anti-Kickback Statute.
  • August 2015: The FDA issued a Safety Communication regarding supplemental measures to enhance duodenoscope reprocessing
  • May 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.”
  • March 2015: FDA issues a Safety Communication to “raise awareness among 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.”

Key takeaways about Olympus endoscope recalls and lawsuits

  • People have reported being harmed by different models of Olympus scopes and accessories used during medical procedures.
  • Injuries can occur when bronchoscopes cause burns to the lungs and airways. Endoscopes can cause serious patient infections.
  • Olympus recalled the devices, but continues to face lawsuits related to the injuries.

Why are people filing Olympus scope lawsuits?

People are filing Olympus lawsuits because of injuries allegedly caused by defective products. Motley Rice is investigating potential injuries that may have been caused by the following Olympus endoscope products or accessories:

  • MAJ-891 Endoscope Accessory
  • OES Bronchofiberscope with model numbers BF-P60, BF-1T60
  • Bronchovideoscope with model numbers BF-1T150, BF-P150, BF-Q170
  • Evis Exera Bronchovideoscope with model numbers BF-XT160
  • Evis Exera II Bronchovideoscope with model numbers BF-Q180-AC, BF-P180, BF-1T180, BF-1TQ180
  • Evis Exera III Bronchovideoscope with model numbers BF-1TH190, BF-H190, BF-Q190, BF-XT190, BF-P190
  • Single Use Guide Sheath Kits with model numbers K-201, K-202, K-203 or K-204
  • ViziShot 2 FLEX (19G) Needles
  • Single Use Ligating Device PolyLoop with model number HX-400U-30

Contact a medical device attorney

If you or a loved one had an endoscopy and suffered from infections and other serious complications, you may be eligible to file a lawsuit.

Contact us today

You can also contact us by calling 1.800.768.4026.

MAJ-891 recall

Produced by the Olympus Corporation, the MAJ-891 is an endoscope accessory attached to the instrument port of certain endoscopes. These devices may examine the bladder, urethra, uterus, cervix, colon and other organs. The MAJ-891 attaches to the endoscope and allows both irrigation and the use of endo-therapy accessories.

The MAJ-891 accessory is at risk of contamination during reprocessing. “Reprocessing” involves cleaning, disinfecting or sterilizing a medical device so it can be reused. The company has now warned of a potential for “inadvertent retention of biomaterial” (e.g., waste material accidentally stays in the device) if medical professionals fail to follow cleaning instructions. Questions remain as to how and whether that reprocessing procedure was adequately constructed and communicated to end users.

The device has not been sold in the United States since 2022. However, the device is reusable, and some were not discarded. Some hospitals and physician offices used the device until recently.

Olympus published an advisory notice in January 2025 stating it had analyzed numerous complaints of adverse events associated with the use of the device, including one death. Customers received a letter in December 2024 instructing them to use available alternatives to the MAJ-891, if possible. The U.S. Food and Drug Administration (FDA) has identified this as a Class 1 recall, which is the most serious type.

This is not the first time Olympus has faced FDA scrutiny regarding its endoscope reprocessing procedures. The FDA criticized Olympus in July and September 2022 for not complying with medical device regulation (MDR) reporting and quality system requirements with its reprocessing of endoscopes. Olympus was also warned about failures in developing reporting procedures that would notify the FDA of “any infections or reprocessing failures” related to the endoscopes.

The Centers for Disease Control and Prevention (CDC) previously raised concerns about the potential association between multidrug-resistant bacteria and the company’s duodenoscopes.

What are endoscopes and bronchoscopes?

Endoscopes are devices that medical professionals use to look inside an organ or body cavity. They have a light attached.

A bronchoscope is a lighted device used for viewing airways in the respiratory system to look for signs of lung diseases.

Medical device manufacturers offer these devices in single-use or reusable versions.

What harms are alleged in Olympus endoscope infection lawsuits?

Patients who were treated with an endoscope fitted with a contaminated MAJ-891 may experience the following:

  • Infection
  • Urinary tract infection
  • Sepsis
  • Death

A subsequent update issued by the FDA on January 31, 2025, stated that Olympus had received reports of 120 injuries and one death caused by infection.

Eligibility to file an Olympus scope endoscope lawsuit

Anyone who has suffered an infection after a surgery in the U.S. that can be linked to using the Olympus MAJ-891 device may be eligible to file a personal injury or wrongful death lawsuit. People may also be able to file a lawsuit on behalf of a loved one if they have passed away since their injury. Some ways to know if you’re eligible include:

  • Your doctor received a letter from Olympus advising of the issue with contamination.
  • Your surgeon used an Olympus MAJ-891 device, and you developed an infection.

If you believe you may have a claim, it’s important to reach out when you become aware of your injuries. A statute of limitations could affect your ability to file a lawsuit. If you attempt to file after it expires, you may be ineligible to seek justice for your injuries.

A medical device attorney can help you file your complaint before the statute of limitations expires.

Bronchoscopes recalls

Olympus received reports of patients having their lungs or airways burned during procedures “that used both the bronchoscope and laser therapy equipment or argon plasma coagulation.” The company issued:

  • A Class 1 recall in October 2023
  • An addition in 2025 that included additional models

The FDA described both recalls as “a correction, not a product removal.” The recall also resulted in a change to the product’s label.

Recalled Olympus bronchoscope models

  • Bronchovideoscope: BF-1T150, BF-P150, BF-Q170
  • Evis Exera Bronchovideoscope: BF-XT160
  • Evis Exera II Bronchovideoscope: BF-Q180-AC, BF-P180, BF-1T180, BF-1TQ180
  • Evis Exera III Bronchovideoscope: BF-1TH190, BF-H190, BF-Q190, BF-XT190, BF-P190
  • OES Bronchofiberscope: BF-P60, BF-1T60

Harms associated with Olympus bronchoscopes

Patients whose bronchovideoscope or bronchofiberscope malfunctioned during a procedure may have experienced:

  • Airway bleeding
  • Apnea
  • Brain injury induced by a lack of oxygen
  • Critical burns in the lungs or airways
  • Death
  • Difficulty breathing
  • Loss of consciousness

Who’s eligible to file an Olympus bronchoscope lawsuit?

If you have experienced symptoms indicating that you’ve been harmed by an Olympus bronchoscope, an attorney can evaluate your claim.

Consider contacting an attorney when you become aware of your injuries. A statute of limitations could affect your ability to file a lawsuit. If you attempt to file after it expires, you may be ineligible to seek justice for your injuries. A medical device attorney can help you file your complaint before the statute of limitations expires.

Other Olympus endoscope accessory recalls

Guide Sheath Kits

Sheath kits are accessories used during endoscopies to help collect cells and tissue specimens. The Olympus Corporation issued a recall of its Single Use Guide Sheath Kits on February 28, 2025. The recall was issued because of the risk that the guide sheath tip could detach during procedures.

Motley Rice is currently investigating injuries that may have happened when the guide sheath tip detached during a procedure.

ViziShot 2 FLEX (19G) needles

ViziShot 2 FLEX needles were designed for use during ultrasound endoscopies. The needles were crucial components for ultrasound-guided fine-needle aspiration and fine-needle biopsies. They were used to explore submucosal and extramural lesions of the tracheobronchial tree.

The Olympus Corporation issued a recall of ViziShot 2 FLEX (19G) EBUS – TBNA needles on September 19, 2025. The recall came after the company received reports of the needle detaching during surgery. The reports of adverse events included one death.

Motley Rice is currently investigating injuries that may have happened when the ViziShot needle detached during ultrasound endoscopies.

Ligating device

The Olympus Single Use Ligating Device PolyLoop is an accessory for the company’s endoscopes. It is used to control bleeding following a polypectomy.

The company issued updated directions for its Single Use Ligating Device PolyLoop Model Number HX-400U-30 on November 3, 2025. The updated directions were issued after the company had received multiple complaints of defects. These defects included the device detaching unexpectedly and becoming anchored within patients.

Motley Rice is currently investigating injuries that may have happened when the Olympus Ligating Device PolyLoop detached during a polypectomy.

Frequently asked questions about Olympus endoscope injury lawsuits

Is there an Olympus scope class action lawsuit?

No, there isn’t an Olympus scope class action lawsuit or a multidistrict litigation (MDL) action. However, people may still be able to file a personal injury or wrongful death lawsuit to seek justice for injuries.

How many people have been injured by Olympus scopes?

According to a bulletin sent to health care providers, there have been nine serious injuries and one death related to Olympus bronchoscopes since 2022.

According to an FDA update issued on January 31, 2025, Olympus had received reports of 120 injuries and one death due to MAJ-891 endoscope infections.

What damages are available in an Olympus scope lawsuit?

Typically, a person harmed by a faulty medical device can sue for:

It’s not possible to guarantee any financial compensation from a lawsuit.

Are there Olympus bronchoscope lawsuits?

Motley Rice attorneys are currently investigating potential claims. Individuals who were harmed because of a faulty Olympus bronchoscope may reach out to discuss their injuries. It may be possible to file a bronchoscope lawsuit.

Our medical device experience

If you’re unsure whether a potentially contaminated product was used during your procedure, a medical device attorney at Motley Rice may be able to help. Our attorneys have investigated similar claims relating to other defective products, including representing patients who suffered infections they believe were caused by endoscope and duodenoscope devices.

Learn more about our medical device litigation experience.

Why are people filing Olympus scope lawsuits?

MAJ-891 recall

Check Your Eligibility

Bronchoscopes recalls

Other Olympus endoscope accessory recalls

Frequently asked questions about Olympus endoscope injury lawsuits

Our medical device experience

s

Attorney Mike Daly

Mike Daly

Member

Mike Daly brings substantial experience representing clients harmed by defective products, pharmaceutical drugs, medical devices, toxic substances, and corporate negligence in complex litigation.

Josey M. Edelman

Associate

Josey Edelman represents clients in litigation alleging corporate negligence involving medications and medical devices, crime victims, technology and toxic exposure.

Sources
  1. California Health Online. Judge Orders New Olympus Trial Over Superbug Death.
  2. Medline. Bronchoscopy.
  3. Medline. Endoscope.
  4. Olympus Corporation of America. Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment.
  5. Olympus Corporation of America. URGENT Medical Device Correction OLYMPUS BRONCHOFIBERSCOPE, BRONCHOVIDEOSCOPES.
  6. U.S. Food & Drug Administration. Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire.
  7. U.S. Food & Drug Administration. Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment.
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