Quick Facts at a Glance
- Recall Date
- November 14, 2025
- Hazard Level
- HIGH
- Brand
- Olympus
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Product type
- Reusable Lithotripsy Probe
- Model numbers
- SPL-SR
- Sold at
- Unknown
- 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 urinary stones using low-frequency mechanical energy and high-frequency ultrasonic energy. Reusable probes require cleaning and steam sterilization between procedures.
Why This Is Dangerous
A blinking generator that does not recognize the transducer can lead to device malfunction. Damage to the transducer plug or generator receptacle increases the risk of improper operation during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to halt certain lithotripsy procedures. The recall focuses on device reliability and patient safety. No injuries are reported in the notice at this time, but the risk is significant for procedural success.
Practical Guidance
How to identify if yours is affected
- Verify model SPL-SR in use.
- Check UDI 00821925043824 on packaging and documentation.
- Confirm serial numbers are All.
- Review hospital recall communications for next steps.
Where to find product info
Identifiers are on device labels, packaging, and user manuals. UDI is also in the FDA recall listing.
What timeline to expect
Replacement or remediation steps are coordinated with Olympus and hospitals within weeks. Expect official timelines from your facility.
If the manufacturer is unresponsive
- Escalate with your hospital’s patient safety officer and biomedical engineering.
- File a complaint with the FDA if you believe the recall process is not moving forward.
How to prevent similar issues
- Maintain an active recall watch for all lithotripsy equipment.
- Work only with authorized distributors and the manufacturer.
- Document serial numbers and UDI for all probes in use.
Documentation advice
Keep copies of the recall notice, correspondence with Olympus, purchase invoices, and device identifiers for future reference.
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Product Details
Model/Catalog Number: SPL-SR. UDI: 00821925043824. Serial numbers: All. Distribution: Worldwide, including the US, Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan. Sold: Unknown. Date sold: Unknown. Price: Unknown.
Key Facts
- Serial numbers: All
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Safety Guide
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