Olympus Corporation of the Americas 2025-11-19 Health serious FDA
Health · FDA · Recall #FDA-Z-0452-2026
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer … Recall
Issued November 19, 2025 · Olympus Corporation of the Americas
In November 2025, Olympus Corporation of the Americas recalled the Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer …, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
What you should do
- 1 Stop using Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Olympus Corporation of the Americas to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Olympus Corporation of the Americas
- Category
- Health
- Recall date
- November 19, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.
- Recall number
- FDA-Z-0452-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.