Use cautionMedical device recall · FDA · Published October 8, 2025
Olympus ShockPulse Lithotripsy Transducer Recall: Device May Stop Working or Overheat
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.
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olympus ShockPulse Lithotripsy Transducer Recall: Device May Stop Working or Overheat.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51091-olympus-shockpulse-lithotripsy-transducer-recall-device-may-stop-working-or. Based on FDA recall #Z-0452-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0452-2026%22&limit=1).
The FDA announced on Oct. 8, 2025, that Olympus Corporation of the Americas is recalling the ShockPulse Lithotripsy Transducer (Model SPL-T) due to startup failures and overheating hazards. Owners should contact the company for remedy details.
How to tell if you have it
Brand: Olympus
Product Name: ShockPulse Lithotripsy Transducer
Model/Catalog Number: SPL-T
UDI-PI: 00855279005023
All serial numbers
The hazard
The device may fail to start up or the transducer may start briefly and then stop, accompanied by an error light on the generator. Additionally, the body of the transducer handpiece may gradually increase in temperature during clinical use.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since Aug. 18, 2017. Recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (Aug. 27, 2026), the Olympus M3 Gold Autoclavable Lateral Telescope 70 (Aug. 24, 2026), and the Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector (Aug. 19, 2026). Other recent recalls of similar products include the I.T.S. GmbH FR.O.H. Calcaneus Repair System (Jan. 23, 2026), the Olympus OER-Pro (Oct. 31, 2025), and the Canon Alphenix INFX-8000F X-Ray System (Dec. 19, 2025).
How to tell if you have this one
Check for the model number SPL-T on the transducer. The device was sold with the ShockPulse Lithotripsy System for kidney stone treatment.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Function
Ensure the transducer starts and runs without stopping or error lights.
Contact Manufacturer
Reach out to Olympus Corporation of the Americas for guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0452-2026 (October 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0452-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.