Olympus Scopes: Recalls and 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

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 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.

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.

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

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.

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.