Olympus recalls ShockPulse Lithotripsy Transducers (SPL-T) that may stop working or overheat during use. Affected units require immediate action to prevent potential injury.
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.
Olymp: Olympus is recalling ShockPulse Lithotri: Transducers (SPL-T) that may stop working or overheat during clinical use. This could lead to incomplete stone fragmentation or injury if not fixed.
The transducer may fail to start or stop unexpectedly during use, causing incomplete stone fragmentation. It can also overheat during clinical procedures, potentially leading to injury if not properly monitored.
Healthcare professionals using the ShockPulse Lithotripsy System for kidney stone treatment are most at risk. Patients receiving this treatment may also be affected if their provider uses the recalled device.
Check for the model number SPL-T on the transducer. The device was sold with the ShockPulse Lithotripsy System for kidney stone treatment.
Ensure the transducer starts and runs without stopping or error lights.
Reach out to Olympus Corporation of the Americas for guidance on next steps.
The device may stop working or overheat during use, so it is not safe without the recall fix.
Check for the model number SPL-T on the transducer, which was sold with the ShockPulse Lithotripsy System for kidney stone treatment.
Contact Olympus Corporation of the Americas for guidance on next steps.
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-0452-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-0452-2026 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.