Olympus Endoscope Recall Lawsuit

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 more. The MAJ-891 attaches to the endoscope and functions to allow both irrigation and the use of endo-therapy accessories.

People are filing Olympus lawsuits because the MAJ-891 accessory is at risk of contamination during reprocessing. “Reprocessing” involves the cleaning, disinfecting, or sterilizing of a medical device so it can be reused. The company has now warned of a potential for “inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed.” 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 hospitals and physician offices were still using 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 were sent 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 it may issue.

This is not the first time Olympus has faced scrutiny from the FDA regarding its endoscope reprocessing procedures. The FDA criticized Olympus in July and September 2022 for being uncompliant 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 ensure the FDA was notified of “any infections or reprocessing failures” connected 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.

Patients utilizing an endoscope with a contaminated MAJ-891 may experience the following:

• Infection
• Urinary tract infection
• Sepsis
• Death

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

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.