Quick Facts at a Glance
- Recall Date
- January 16, 2026
- 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
- Insufflation Unit
- Model numbers
- Model Number: UHI-2, UDI-DI: N/A, All Serial Numbers
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 16, 2026
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Issue with software algorithm which may lead to overpressure events.
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 Olympus High Flow Insufflation Unit is used in laparoscopic surgeries to insufflate the abdominal cavity. It allows for automatic suction and smoke evacuation, facilitating better observation and treatment.
Why This Is Dangerous
The software algorithm issue can lead to overpressure situations, which may compromise patient safety during surgical procedures. This malfunction could lead to serious complications during laparoscopic surgery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face potential safety risks, necessitating immediate cessation of use to avoid serious injury.
Practical Guidance
How to identify if yours is affected
- Check if your unit is Model UHI-2
- Verify the unit is part of the 744 recalled units
- Stop all usage of the device immediately
Where to find product info
Look for the model number and identification information on the device's label or documentation.
What timeline to expect
Expect a response from Olympus within 4-6 weeks regarding refund or replacement processes.
If the manufacturer is unresponsive
- Document all communication attempts
- Contact the FDA if no response is received
- Consider consulting a legal advisor if necessary
How to prevent similar issues
- Always check for recalls on medical devices before use
- Ensure devices are regularly updated and maintained
- Follow manufacturer guidelines closely during usage
Documentation advice
Keep records of all communications regarding the recall, including emails, letters, and phone calls.
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Product Details
The recalled product is the Olympus High Flow Insufflation Unit, Model UHI-2. It was distributed nationwide and sold to healthcare providers and institutions.
Key Facts
- Risk of overpressure events
- Class I recall
- Immediate stop-use required
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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