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-3, UDI-DI: 04953170140280, 04953170140297, 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, Model UHI-3, is used during laparoscopic procedures for insufflation, suction, and smoke evacuation. Medical professionals rely on this device to create a clear view of the abdominal cavity for treatment.
Why This Is Dangerous
The software algorithm malfunction can lead to overpressure in the abdominal cavity during procedures, which may result in serious complications for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects medical settings where the device is used, potentially delaying procedures and requiring alternative solutions until the issue is resolved.
Practical Guidance
How to identify if yours is affected
- Check the model number: UHI-3.
- Verify if your unit has the UDI-DI: 04953170140280 or 04953170140297.
- Ensure the device is within the recalled quantity of 485 units.
Where to find product info
The model number and UDI-DI can typically be found on the device's label or in the user manual.
What timeline to expect
Expect to receive further instructions and potential refunds within 4-8 weeks after the recall notification.
If the manufacturer is unresponsive
- Contact Olympus Corporation of the Americas directly via their customer service.
- Document all correspondence and attempts to reach Olympus.
How to prevent similar issues
- When purchasing medical devices, verify if they have current safety certifications.
- Stay informed about recalls within the medical device industry.
- Consult with healthcare professionals about the latest safe devices on the market.
Documentation advice
Keep copies of any correspondence with Olympus, receipts, and any documentation related to the recall for your records.
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Product Details
The recalled product is the Olympus High Flow Insufflation Unit, Model Number UHI-3. It has a Unique Device Identifier (UDI-DI) of 04953170140280 and 04953170140297. The units were distributed nationwide.
Key Facts
- Model Number: UHI-3
- Software algorithm issue
- Stop using immediately
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Safety Guide
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