Olympus Recalls ShockPulse-SE Lithotripsy System Reusable Probes Due to Recognition Issues
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Olympus Corporation of the Americas has initiated a voluntary recall of 602 ShockPulse-SE Lithotripsy System Reusable Probes due to a defect where the generator fails to recognize the transducer.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 2, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of the ShockPulse-SE Lithotripsy System Reusable Probes. Ongoing investigations identified instances where the device generator remains in a "blinking phase" while waiting to recognize the transducer. This malfunction is caused by damage to the transducer plug and/or the generator receptacle, which prevents the system from functioning as intended.
Which Products Are Affected
The recall affects the following medical device components:
- Brand Name: ShockPulse-SE Lithotripsy System SPL-SR
- Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes
- Model/Catalog Number: SPL-SR
- UDI: 00821925043824
- Serial Numbers: All serial numbers are included
- Quantity: 602 units
This recall impacts products distributed worldwide, including the United States, Canada, Mexico, Bolivia, Chile, India, China, the European Union, Singapore, Australia, Korea, and Japan.
What You Should Do
The recall was initiated via a notification letter to affected customers. Healthcare facilities and providers using the ShockPulse-SE Lithotripsy System should inspect their equipment for damage to the transducer plug or generator receptacle. If the generator remains in a blinking phase and fails to recognize the transducer, the device should not be used. For further information regarding returns or technical support, contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.
Why This Matters
The ShockPulse Lithotripsy System is a critical electromechanical device used to fragment calculi and aspirate stone debris during medical procedures. A failure of the generator to recognize the transducer can lead to procedural delays or the inability to perform the lithotripsy as required.
Source
Information provided by the FDA under Recall Number Z-1477-2026.
Original source: FDA Official Notice ↗
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