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Why Did the FDA Ban Some Olympus Scopes in the U.S.?

Olympus scopes help doctors diagnose and treat serious conditions, but some devices have been linked to dangerous infections. Over the past decade, the U.S. Food and Drug Administration (FDA) escalated its response to these products, moving from safety warnings to recalls and, eventually, to blocking dozens of Olympus devices from entering the country. If you underwent a procedure with one of these scopes, you may have grounds for legal action. Contact our Olympus scope infection attorney for assistance with your case.

What Are Olympus Scopes, and How Are They Used?

Olympus scopes are flexible instruments that doctors use to see inside the body during minimally invasive procedures. The duodenoscope is often named in Olympus scope lawsuits. This side-viewing scope allows doctors to view the bile and pancreatic ducts and treat conditions such as gallstones, blockages, and certain cancers.

Beyond duodenoscopes, Olympus also produces:

  • Bronchoscopes, used to examine the airways and lungs
  • Cystoscopes and ureteroscopes, used to view the bladder and urinary tract
  • Choledochoscopes, used to inspect the bile ducts
  • Hysteroscopes, used to examine the uterus

What Prompted the FDA to Act Against Certain Olympus Devices?

At the tip of a duodenoscope is a movable part called the elevator mechanism, which helps doctors guide instruments during a procedure. This component contains tiny crevices where biological material collects, and bacteria can survive there even when hospitals follow the manufacturer’s cleaning instructions. Contaminated scopes can then transmit infections from one patient to the next.

In 2015, the FDA issued safety communications warning that the complex design of duodenoscopes could interfere with proper cleaning and reprocessing. In January 2025, the FDA identified a Class 1 recall of the MAJ-891 Forceps/Irrigation Plug, an accessory used with several Olympus scopes, as its most serious recall type, cautioning that continued use could cause serious injury or death. On June 24, 2025, the FDA issued import alerts that blocked future shipments of certain Olympus devices made at the company’s facility in Japan from entering the United States, citing ongoing quality system violations.

Legal Action Involving Olympus Scopes in the United States

Patients harmed by Olympus scopes are now suing the manufacturer. These lawsuits allege that the scopes were defectively designed in a way that made reliable cleaning nearly impossible. Despite knowing about the risks, Olympus did not adequately warn hospitals or regulators, causing patients to suffer infections, prolonged illnesses, or death as a result.

By filing an Olympus scopes lawsuit, victims can recover compensation for:

  • Medical expenses
  • Lost wages
  • Reduced earning potential
  • Chronic pain, permanent disability, and other physical effects
  • Emotional distress, depression, anxiety, and post-traumatic stress
  • Loss of enjoyment of life’s activities
  • Wrongful death damages, such as funeral and burial expenses, if filing on behalf of a loved one who passed away

What to Do If You Were Harmed by a Defective Olympus Scope

If you developed an infection after a procedure involving an Olympus device, a few steps can protect both your health and any potential claim. First, seek medical care as soon as possible to treat your condition. When you are able, request copies of your medical records, including the procedure notes and the device used. Then, speak with an Olympus scope lawsuit attorney as soon as possible.

Speak with Shapiro Legal Group, PLLC About Your Injury Today

At Shapiro Legal Group, PLLC, we recognize how unsettling it is to suffer harm from a device meant to help you heal. Our attorneys will hold Olympus accountable and pursue the compensation you may be owed. Contact us today to discuss your options and learn how we can help.