Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OLYMPUS ShockPulse-SE Lithotripsy System Recalled by Olympus Corporation of the Americas Due to A component of the Olympus ShockPulse Transducer was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Quantity: 18
Why Was This Recalled?
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report