Olympus ShockPulse-SE Lithotripsy System Recall (Class II)

FDA: Device Recalls Class II

Filed March 11th, 2026

Detected March 29th, 2026

Summary

The FDA has issued a Class II recall for the Olympus ShockPulse-SE Lithotripsy System with Generator due to a mis-wired component that may affect system reliability and cause delays. The recall impacts international distribution, including Canada, Germany, Singapore, Australia, and India.

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What changed

The FDA has classified a Class II recall for Olympus Corporation of the Americas' ShockPulse-SE Lithotripsy System with Generator (Models SPL-SR, SPL-G). The reason for the recall is a mis-wired component that can lead to inconsistent power supply output, potentially decreasing system reliability and causing treatment delays. This issue is not consistent with electromagnetic compatibility (EMC) standards.

This recall affects international distribution in Canada, Germany, Singapore, Australia, and India. While the document does not specify immediate actions for healthcare providers or device makers, entities in possession of the affected devices should consult Olympus for specific instructions regarding the recall and potential remediation steps to ensure patient safety and system integrity.

What to do next

Review affected device inventory for Olympus ShockPulse-SE Lithotripsy System with Generator (Models SPL-SR, SPL-G).
Consult Olympus for specific recall instructions and remediation steps.
Ensure compliance with international distribution recall requirements for affected countries.

Source document (simplified)

Olympus Corporation of the Americas

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1494-2026 · 20260311 · Ongoing

Product

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Produ...

Reason for Recall

Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of tr...