Quick Facts at a Glance
- Recall Date
- January 8, 2026
- Hazard Level
- HIGH
- Brand
- Olympus
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Olympus
- Product type
- Lithotripsy System with Generator
- Model numbers
- SPL-SR, SPL-G
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 8, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
About This Product
The ShockPulse-SE Lithotripsy System fragments urinary tract stones using pneumatic shock waves and ultrasonic energy. It typically includes a control unit, handpieces, and two probe types.
Why This Is Dangerous
A mis-wired component can cause noise on the power supply and ultrasonic input circuit, potentially decreasing system reliability and delaying treatment.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may need to suspend use of affected equipment and implement alternative stone-treatment methods while the recall is addressed.
Practical Guidance
How to identify if yours is affected
- Identify SPL-SR and SPL-G components
- Check serial numbers CG5026–CG5042
Where to find product info
Look on device labels, the UDI plate, and hospital-maintained equipment records
What timeline to expect
Remediation timelines vary; expect weeks to months for replacement or repair processes
If the manufacturer is unresponsive
- Escalate to hospital procurement and the Olympus recall contact
- File a formal recall complaint with the hospital risk manager
- Consider contacting regulatory bodies if there is slow response
How to prevent similar issues
- Regularly verify EMC compliance in medical devices during procurement
- Maintain an up-to-date inventory of critical medical devices and serial numbers
- Follow manufacturer recall communications promptly
Documentation advice
Keep the recall notification, serial numbers, UDI labels, correspondence with Olympus, and any incident reports for records
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Product Details
Model/Catalog Numbers: SPL-SR; SPL-G (generator). UDI: SPL-SR 00821925043824; SPL-G 00821925044203. Serial Numbers: CG5026–CG5042. Quantity: 55 units. Sold internationally in Canada, Germany, Singapore, Australia, and India. Recall date: 2026-01-08. Status: ACTIVE. Brand: Olympus. Category: Medical devices distributed through international channels.
Key Facts
- 55 units recalled (All OUS)
- Model/SPL-SR; Generator SPL-G
- Serials CG5026–CG5042
- Countries: Canada, Germany, Singapore, Australia, India
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Safety Guide
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