Quick Facts at a Glance
- Recall Date
- November 14, 2025
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- 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 Corporation of the Americas
- Product type
- Single-use lithotripsy probes
- Model numbers
- Model/Catalog Number: SPL-S, UDI: 00821925044197, Serial Numbers: All
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 14, 2025
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
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 Lithotripsy System is used to fragment kidney stones and aspirate debris. The transducer is reusable and requires cleaning and steam sterilization before use.
Why This Is Dangerous
A blinking generator that fails to recognize the transducer can indicate internal electrical or receptacle issues. Damaged plugs or receptacles may lead to device malfunction during procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics may need to halt procedures using this device and turn to safe alternatives. The recall could affect procurement and operational workflow for lithotripsy services.
Practical Guidance
How to identify if yours is affected
- Verify device model SPL-S
- Confirm serial numbers: All
- Review manufacturer recall communications
Where to find product info
UDI on packaging and labeling; model number printed on device; recall letter from Olympus
What timeline to expect
Typically 4-6 weeks for refunds or replacements after approval
If the manufacturer is unresponsive
- Escalate to hospital recalls committee
- Contact FDA consumer product or medical device recall programs
- Consider legal counsel if vendor remains unresponsive
How to prevent similar issues
- When buying lithotripsy devices, verify UDI and recall status
- Register for recall alerts from manufacturers and FDA
- Ensure proper sterilization and handling protocols for reusable transducers
Documentation advice
Retain recall letter, save all email/phone communications, log device serials and UDI, keep purchase records and replacement confirmations
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Product Details
Model/Catalog Number: SPL-S. UDI: 00821925044197. Serial Numbers: All. Distribution: Worldwide, including US, Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. Sold at: Unknown. Sold since: Unknown. Price: Unknown. Quantity: 1082 units. Country of origin: Unknown. Classification: Class II.
Key Facts
- Serial Numbers: All
- Worldwide distribution including US, Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, AU
- Classification: Class II
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