FDA Issues Its Most Serious Recall of an Olympus Scope Part Linked to 120 Injuries and One Death

The FDA has issued its most serious type of recall for a small but important Olympus device part — one tied to 120 injuries and one death.

The part is called the MAJ-891 Forceps/Irrigation Plug. It is a reusable accessory that attaches to certain Olympus endoscopes. And according to the FDA, when it was not cleaned exactly the right way, it could carry bacteria from one patient to the next.

What Is a Class I Recall?

The FDA uses three levels to classify recalls. Class I is the most serious. It means the FDA believes there is a reasonable chance the product could cause serious harm or death.

The MAJ-891 recall is a Class I recall. That is the strongest warning the FDA gives.

What Is the MAJ-891 and What Does It Do?

The MAJ-891 is a small reusable plug that connects to the instrument channel of certain Olympus scopes. It was used with scopes including:

• Cystoscopes (used to look inside the bladder)
• Ureteroscopes (used to look at the kidney and ureter)
• Choledochoscopes (used to look at the bile ducts)
• Hysteroscopes (used to look inside the uterus)

Doctors rely on these scopes for both routine check-ups and to diagnose and treat serious conditions.

The MAJ-891 itself is designed to be cleaned and reused. But that reuse came with a serious condition: the plug had to be fully taken apart before it could be cleaned properly. If hospital staff did not fully disassemble it — every single time — bacteria and other material from a previous patient could remain on the device.

120 Injuries. One Death.

The FDA confirmed that the MAJ-891 was connected to 120 reports of injury and one death related to infection.

The FDA warned that patients exposed to a contaminated MAJ-891 could develop:

• Infection
• Sepsis (a dangerous, body-wide response to infection that can be fatal)
• Death

When hospital staff skipped or shortcut the disassembly step during cleaning, there was a risk that biological material — including bacteria — could stay inside the plug and be transferred to the next patient.

Olympus Knew About the Problem

Olympus first warned customers about the MAJ-891 issue on December 18, 2024. The company sent out a notice telling hospitals to use alternative devices instead of the MAJ-891.

About six weeks later, the FDA stepped in with a formal Class I recall.

Importantly, Olympus had already stopped selling the MAJ-891 in the United States in 2022. But the recall covers devices already in use — the FDA identified more than 30,000 devices that had been distributed across the country and were potentially still being used in hospital settings.

That means patients could have been exposed to this device even though it had been off the market for years.

Did You Have a Procedure Involving These Scopes?

The MAJ-891 was used with scopes that go inside the bladder, kidneys, bile ducts, and uterus. If you had any of the following procedures and developed an infection afterward, the MAJ-891 could potentially be involved:

• Cystoscopy (bladder exam)
• Ureteroscopy (kidney or ureter exam)
• Bile duct procedure (ERCP or similar)
• Hysteroscopy (uterine exam)

Symptoms of an infection after one of these procedures can include fever, chills, pain, or feeling suddenly very sick in the days or weeks following the procedure. Sepsis — the most dangerous outcome — can come on quickly and can be life-threatening.

This Is Part of a Bigger Problem With Olympus

The MAJ-891 recall is not an isolated incident. It is part of a much larger pattern of safety problems with Olympus scopes and devices.

In the same period, Olympus also issued a worldwide safety notice about infections and deaths tied to its TJF-series duodenoscopes. And in June 2025, the FDA blocked new Olympus devices from entering the United States because of ongoing problems at the company's factory in Japan.

Between 2013 and 2024, contaminated Olympus scopes were linked to infections in hundreds of patients across the U.S., and at least 35 people died.

The MAJ-891 recall shows that the problem extends beyond just duodenoscopes — it affects a range of Olympus products and procedures. If you're not sure whether your situation might qualify, the 3-part qualification test takes about 2 minutes.

Sources

• Update on Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus — FDA
• Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 — FDA
• FDA Labels Recall of Discontinued Olympus Endoscope Part as Class I — MedTech Dive
• Olympus Endoscope Components Linked to 120 Patient Injuries and 1 Death, FDA Warns — About Lawsuits
• Recall Roundup: FDA Medical Device Recalls During January — Healthcare Brew
• Olympus Scope Contamination Lawsuits and Patient Injuries — Rheingold Law
• Olympus Endoscope Recall — Motley Rice