Brand Name: Lithotriptor recall
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse…
Why was Brand Name: Lithotriptor recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;
- Product
- Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1528 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.
- Recall date
- November 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)