Lower riskMedical device recall · FDA · Published November 14, 2025
Olymp: ShockPulse-SE Lithotripsy System Generator Recall - Transducer Damage Risk
Olympus recalls ShockPulse-SE Lithotripsy System Generator (SPL-G) due to risk of transducer plug or receptacle damage causing device malfunctions. Affected units have all serial numbers.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
“Olymp: ShockPulse-SE Lithotripsy System Generator Recall - Transducer Damage Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50651-olymp-shockpulse-se-lithotripsy-system-generator-recall-transducer-damage-risk. Based on FDA recall #Z-1479-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1479-2026%22&limit=1).
The FDA announced on Nov. 14, 2025, that Olympus Corporation of the Americas is recalling the ShockPulse-SE Lithotripsy System - Generator (Model SPL-G) due to a hazard where the device may remain in a blinking phase. The agency said this issue stems from potential damage to the transducer plug or generator receptacle.
How to tell if you have it
Brand: Olympus
Product Name: ShockPulse-SE Lithotripsy System - Generator
Model/Catalog Number: SPL-G
UDI: 00821925044203
Serial Numbers: All
The hazard
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable (2026-08-27), the Olympus M3 Gold Autoclavable Foroblique Telescope (2026-08-24), and the Olympus BiCOAG Hemostasis Probe (2026-08-19). Other recent recalls of similar products include the Olympus OER-Pro Recall (2025-10-31), the GE Allia Moveo X-ray System Recall (2026-04-20), and the GE Medical Systems Allia IGS 3 Pulse X-Ray System Recall (2026-04-20).
How to tell if you have this one
Check for the model number SPL-G on the generator. All units have serial numbers and are affected.
Brand
Olympus
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
Recall number
Product, codes & lots
Quantity
Z-1477-2026
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.; Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;
602 units
Z-1478-2026
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.; Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All;
1082 units
Z-1479-2026
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.; Model/Catalog Number: SPL-G; UDI: 00821925044203; Serial Numbers: All;
1684 units
Based on the official FDA remedy
What to do — step by step
Check Generator Model
Look for the model number SPL-G on the generator to confirm it's affected.
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, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.” 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 4 months 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 recall is for potential damage to the transducer plug or receptacle, which could cause device malfunctions. However, the hazard is not described as causing serious injury in normal use.
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-1479-2026 (November 14, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1479-2026 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.