Olympus Recall Issued Over ShockPulse Device Miswiring: FDA

Multiple recalls have been issued in recent years involving potentially defective Olympus probes and medical devices, which have been linked to infections and serious injuries.

Federal health officials are warning about potentially serious problems with Olympus ShockPulseSE Lithotripsy System reusable probes, after identifying a wiring defect that may delay treatment.

The U.S. Food and Drug Administration (FDA) announced the Olympus ShockPulseSE Lithotripsy System recall on March 5,  indicating that a miswired component in some devices may generate electrical noise in the power supply. According to the agency, the interference could reduce the system’s reliability during procedures used to break up kidney, ureter or bladder stones.

The recall expands an earlier corrective action initiated by Olympus on January 8 after the company discovered additional generators that may contain the improperly wired component.

The Olympus ShockPulseSE Lithotripsy System is used during procedures to remove large kidney and urinary tract stones. The device combines ultrasonic energy with mechanical shockwave technology to break stones apart inside the kidney or ureter during minimally invasive surgeries. Once fragmented, the debris can be suctioned out through an endoscopic instrument, most commonly during a procedure known as percutaneous nephrolithotomy, or PCNL.

According to the recall notice, some of the system’s generators may contain a component that was improperly wired during manufacturing. The defect can create electrical noise in the device’s power supply, potentially interfering with the lithotripsy probe’s performance and reducing the overall reliability of the system. If the problem occurs during a procedure, it could interrupt the device’s operation and delay treatment while surgeons attempt to restore functionality.

The recall comes amid broader safety concerns involving Olympus medical equipment. Late last year, the company also recalled certain endoscope forceps plugs after reports linked the reusable devices to serious infections, resulting in more than 100 patient injuries and at least one reported death. In addition, reusable Olympus probes have been linked to infection problems in recent years, due to difficulties cleaning the devices between patients.

The new Olympus recall was issued for dozens of ShockPulseSE Lithotripsy Systems with model/catalog number SPL-SR, containing generator SPL-G and unique device identifiers (UDIs): SPL-SR 00821925043824 and SPL-G 00821925044203. A full list of affected serial numbers can be found in the FDA recall notice.

The FDA has announced the current Olympus issue as a Class 2 recall, which is a voluntary action taken for products that could cause injury, but are not immediately life-threatening.

Olympus notified health care providers about the concern in an “Urgent: Medical Device Correction” letter issued on January 8, advising hospitals and surgical centers to review their inventory and determine whether they have any affected ShockPulse devices currently in use.

Facilities that identify impacted units have been instructed to contact Olympus customer service to obtain a Return Material Authorization and arrange for the devices to be sent back to the manufacturer. Olympus indicates that the affected generators will be repaired at no cost and then returned to the facility for continued use.

The company also asked customers to share the notice with any other providers who may have received or redistributed the affected devices, and urged health care providers to report any complaints or device problems to the Olympus Technical Assistance Center and to the FDA.

Any adverse events associated with the device may also be submitted through the FDA’s MedWatch adverse event reporting program.

Olympus Probe Recalls

Olympus has faced multiple recalls due to injury concerns linked to its probes in recent years.

In December 2025, officials warned that improper cleaning of certain Olympus MAJ-891 Endoscope forceps/irrigation plug components had resulted in serious patient infections, which had caused at least 120 injuries and one death.

That same month, a recall involving the Olympus PolyLoop Endoscope Ligation device was linked to 113 reports of serious injuries. In that case, it was discovered that the loop could become stuck around a patient’s tissue during procedures, leading to severe tissue or mucosal injuries that could result in long procedural delays or hospitalizations.

A prior Olympus endoscope needle recall was issued in September 2025, due to concerns that components may detach during procedures, creating a risk to patient safety. In March 2025, an Olympus guide sheath recall was issued following dozens of serious injuries resulting from the tips of those devices detaching inside patients.

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