PlainRecordsBrand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name… and 2 more products
- Reason
- 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.
- Status
- Ongoing
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
- Enforcement report date
- March 11, 2026
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Olympus Corporation of the Americas
- Reason
- 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.
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
What this record is about
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“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.”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., FDA enforcement report, 2026-03-11. The caption is the record's own words.
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FDA device name: Lithotriptor, Ultrasonic
3 products in this recall
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System…
- Product
- 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.
- Quantity
- 602 units
- Codes and lots
- Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;
- Recall started
- Nov. 14, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Lithotriptor, Ultrasonic
- Root cause (FDA)
- Device Design
- What the company told customers
- On or about December 18, 2025 URGENT: MEDICAL DEVICE CORRECTION - UPDATE letters were sent to customers. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new Supplemental Guidance. Add a copy of this letter with the Supplemental Guidance to your existing Instruction for Use. You may continue to use the device according to this letter and the instruction for use, which cautions users to ensure that a back-up transducer and probe are sterilized and available prior to beginning a procedure. If you have further distributed this product, identify and forward this notification to them.
- Recall number
- Z-1477-2026
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System…
- Product
- 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.
- Quantity
- 1082 units
- Codes and lots
- Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All;
- Recall started
- Nov. 14, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Lithotriptor, Ultrasonic
- Root cause (FDA)
- Device Design
- What the company told customers
- On or about December 18, 2025 URGENT: MEDICAL DEVICE CORRECTION - UPDATE letters were sent to customers. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new Supplemental Guidance. Add a copy of this letter with the Supplemental Guidance to your existing Instruction for Use. You may continue to use the device according to this letter and the instruction for use, which cautions users to ensure that a back-up transducer and probe are sterilized and available prior to beginning a procedure. If you have further distributed this product, identify and forward this notification to them.
- Recall number
- Z-1478-2026
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System…
- Product
- 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.
- Quantity
- 1684 units
- Codes and lots
- Model/Catalog Number: SPL-G; UDI: 00821925044203; Serial Numbers: All;
- Recall started
- Nov. 14, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Lithotriptor, Ultrasonic
- Root cause (FDA)
- Device Design
- What the company told customers
- On or about December 18, 2025 URGENT: MEDICAL DEVICE CORRECTION - UPDATE letters were sent to customers. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new Supplemental Guidance. Add a copy of this letter with the Supplemental Guidance to your existing Instruction for Use. You may continue to use the device according to this letter and the instruction for use, which cautions users to ensure that a back-up transducer and probe are sterilized and available prior to beginning a procedure. If you have further distributed this product, identify and forward this notification to them.
- Recall number
- Z-1479-2026
This recall among the others
- FDA's enforcement report came 117 days after the firm started the recall. For half of the 860 FDA medical device recall events reported in 2026 so far with a start date, it took 49 days or fewer (by year).
- Olympus Corporation of the Americas: 77 other recalls or notices on this site in the three years before this one (from March 12, 2023).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement reports, recall numbers Z-1477-2026, Z-1478-2026, Z-1479-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1477-2026, March 11, 2026. "Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name… and 2 more products." PlainRecords, https://plainrecords.com/recall/device/z-1477-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections