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
- Lithotripsy System Generator SPL-G
- Model numbers
- SPL-G
- 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 fragments stones and aspirates debris. The transducer is reusable and requires cleaning and steam sterilization.
Why This Is Dangerous
A blinking generator may fail to recognize the transducer, potentially causing malfunctions due to damage to the transducer plug or generator receptacle.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
Hospitals and clinics may need to halt procedures using SPL-G generators until recall instructions are followed. The recall impacts equipment used in stone fragmentation procedures.
Practical Guidance
How to identify if yours is affected
- Confirm model SPL-G and UDI 00821925044203
- Check if the generator is blinking or not recognizing the transducer
- Consult the recall letter for next steps
Where to find product info
FDA recall page and manufacturer communications; official recall letter from Olympus
What timeline to expect
Not specified in the provided data; follow the recall letter for instructions and potential repair/replacement timelines
If the manufacturer is unresponsive
- Escalate to hospital compliance officer
- File a consumer safety complaint with the CPSC if applicable
- Seek guidance from your healthcare provider and facility procurement
How to prevent similar issues
- Verify device recalls during vendor audits and device registries
- Maintain sterilization and inspection protocols for reusable transducers
- Monitor device blinks or error messages during use and report immediately
Documentation advice
Keep the recall letter, note the device model, UDI, serial numbers, and all communications with Olympus or clinicians; photograph any device issues
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Product Details
Model/Catalog Number: SPL-G. UDI: 00821925044203. Serial Numbers: All. Distribution: Worldwide, including US nationwide and Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. When sold: Unknown. Price: Unknown.
Key Facts
- 1684 units recalled worldwide
- Model SPL-G; UDI 00821925044203; Serial Numbers: All
- Overall hazard: blinking generator phase may fail to recognize transducer and cause damage to plugs/
- Recall status: ACTIVE as of 2026-03-11
- Distribution: US nationwide and many countries worldwide
- Remedy: stop use immediately; follow manufacturer recall instructions
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