Olympus Recalls ShockPulse-SE Lithotripsy System Probes Due to Recognition Issues
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Olympus Corporation of the Americas has initiated a voluntary recall of 1,082 ShockPulse-SE Lithotripsy System single-use probes due to potential generator recognition failures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 3, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
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What Happened
Olympus Corporation of the Americas has initiated a voluntary recall of certain ShockPulse-SE Lithotripsy System components. Ongoing investigations identified instances where the device generator remains in a "blinking phase" while waiting to recognize the transducer. This failure to recognize the transducer is reportedly caused by damage to the transducer plug and/or the generator receptacle.
Which Products Are Affected
The recall involves the single-use probes used with the ShockPulse-SE Lithotripsy System. The following details identify the affected units:
- Brand Name: ShockPulse-SE Lithotripsy System SPL-S
- Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes
- Model/Catalog Number: SPL-S
- UDI: 00821925044197
- Serial Numbers: All serial numbers are included in this recall.
- Quantity: 1,082 units
- Distribution: Worldwide, including United States nationwide and international distribution to Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
What You Should Do
Olympus initiated the recall through a formal notification letter to affected customers. Healthcare facilities and distributors possessing these units should follow the specific instructions provided in the firm's notification. For additional information or inquiries regarding the return or inspection process, consumers can contact Olympus Corporation of the Americas at their headquarters: 3500 Corporate Pkwy, Center Valley, PA 18034-8229.
Why This Matters
The ShockPulse-SE system is an electromechanical device used to fragment calculi and aspirate stone debris during medical procedures. A failure in the generator's ability to recognize the transducer can lead to device malfunction, potentially delaying or interrupting surgical treatments.
Source
This information is based on the official FDA Recall Notice (Recall Number: Z-1478-2026).
Original source: FDA Official Notice ↗
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