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SHOCKPULSE recallZ-1494-2026 · Olympus Corporation of the Americas · initiated Jan 8, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.

FDA root cause category: Device Design

What the company is doing

On January 8, 2026, URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Examine your inventory and identify any affected devices. 2. Contact your Olympus Customer Service contact to obtain a Return Material Authorization and arrange for the return of your device. Olympus will repair the affected part at no charge and return the device back to you. 3. If you have further distributed the affected products, please forward this notification to other users who may have them. Olympus requests you to report any complaints related to the ShockPulse device to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

Recall details

Recall number
Z-1494-2026
Status
Open, Classified
Initiated by the company
Jan 8, 2026
Posted by the FDA
Mar 5, 2026
Recalling firm
Olympus Corporation of the Americas
Quantity
55 units (All OUS)
Product code
FEO
FDA submissions
K171024
Distribution
International distribution in the country of Canada, Germany, Singapore, Australia, and India.

Product description

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

Code information (models, lots, serial numbers)

Model/Catalog Number: SPL-SR, contains generator SPL-G; UDI: SPL-SR 00821925043824, SPL-G 00821925044203; Serial Numbers: CG5026, CG5027, CG5028, CG5029, CG5030, CG5031, CG5032, CG5033, CG5034, CG5035, CG5036, CG5037, CG5039, CG5040, CG5041, CG5042, CG5043, CG5045, CG5046, CG5047, CG5048, CG5049, CG5050, CG5051, CG5052, CG5053, CG5054, CG5055, CG5056, CG5057, CG5058, CG5059, CG5060, CG5061, CG5062, CG5063, CG5065, CG5066, CG5067, CG6037, CG6061, CG6069, CG6070, CG6071, CG6088, CG6094, CG6095, CG6096, CG6097, CG6098, CG6099, CG7000, CG7001, CG7002, CG7003;

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K171024 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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