Olympus Endoscope Recalls, FDA Warnings & Safety Notices (2025 Update)
When medical device manufacturers fail to ensure their products are safe, regulatory agencies like the FDA and the manufacturers themselves issue warnings. However, these “Field Safety Notices” often do not reach the patients who have already been harmed.
Below is a timeline of the most recent and critical safety alerts regarding Olympus medical devices, including a massive FDA import restriction and an urgent warning regarding fatal infection risks.
October 17, 2025: Urgent Field Safety Notice (Duodenoscopes)
Affected Models: TJF-Q190V, TJF-Q290V, and TJF-Q170V
Reason: Inadequate Cleaning Instructions & Infection Risk
On October 17, 2025, Olympus issued a worldwide “Urgent Field Safety Notice” admitting that their previous reprocessing (cleaning) materials required updates to “minimize potential deviations.”
This alert was triggered by Olympus’s “ongoing assessment… to address positive cultures and infections.” 222The company explicitly warned healthcare providers that improper reprocessing could lead to “exposure to a contaminated device which may result in patient infection,” ranging from minor illness to “life-threatening, and possibly death.”
Key Admissions in this Notice:
- New Inspection Requirements: Olympus now states that naked-eye inspection of the device tip is insufficient. They introduced a “Visual Inspection Guide” requiring the use of 10X magnification tools to identify irregularities and damage that could trap bacteria.
- Patient Casualties: The notice confirms that from 2024 to present, Olympus received 2 reports of death and 5 reports of serious injury related to infection or positive cultures involving the TJF duodenoscope. 5
June 24, 2025: FDA Import Alert (Japan Manufacturing)
Affected Products: 58 Models (Ureterorenoscopes, Bronchoscopes, Laparoscopes, and Automated Endoscope Reprocessors)
In a significant regulatory move, the FDA issued an Import Alert on June 24, 2025, targeting Olympus medical devices manufactured in Japan. This alert was designed to prevent specific Olympus products from entering the United States due to violations of federal standards.
The alert highlights a broad failure in quality control and manufacturing practices. Unlike a voluntary recall, an Import Alert allows the FDA to detain products at the border without physical examination, signaling a severe lack of trust in the manufacturer’s current safety compliance.
The Pattern: A History of Hidden Risks (2018–Present)
The alerts in 2025 are not isolated incidents; they are part of a documented history of negligence regarding infection control.
- 2018 DOJ Guilty Plea: Olympus Medical Systems Corp. and a former senior executive pleaded guilty to failing to file required adverse event reports. The company admitted it did not alert the FDA about clusters of infections in Europe while continuing to sell the same devices in the U.S. The company was fined $85 million.
- Repeated “User Error” Defenses: For years, Olympus has blamed hospital staff for infections. However, the October 2025 update—requiring new 10X magnification tools—suggests that the devices are so complex that standard hospital cleaning verification is impossible without specialized equipment.
What This Means for Patients
If you underwent a procedure (such as an ERCP, Bronchoscopy, or Ureteroscopy) in 2024 or 2025 and subsequently developed a serious infection, the device used on you may have been subject to these warnings.
The timeline is critical:
- If your procedure was before Oct 17, 2025: The hospital staff likely did not have the “updated” Visual Inspection Guides or the requirement to use 10X magnification, meaning a contaminated scope could easily have passed inspection.
- If your procedure was after June 2025: The device may be one of the models the FDA flagged for quality control issues.
Contact Nigh Goldenberg. We are currently investigating how these safety lapses contributed to patient infections at major hospitals, including Vanderbilt, UCLA, and Providence.
