The Recall Desk

FDA (Devices) recall action 98359

Olympus Corporation of the Americas recalled 3 products on 2026-03-11

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2026-03-11
Critical
0
Units
3,368

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • HighFDA (Devices)··2026-03-11

    Olympus lithotripsy single use probes recalled over generator recognition failure

    Olympus is recalling ShockPulse-SE Lithotripsy System single use probes after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-03-11

    Olympus lithotripsy reusable probes recalled over generator transducer recognition failure

    Olympus is recalling ShockPulse-SE Lithotripsy System reusable probes after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-03-11

    Olympus lithotripsy generator recalled over transducer recognition failure

    Olympus is recalling the ShockPulse-SE Lithotripsy System Generator after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.

    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.
    Category
    Distribution
    0 states