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
- 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 Corporation of the Americas
- Product type
- Insufflation Unit
- Model numbers
- Model Number: UHI, UDI-DI: N/A, All Serial Numbers
- Sold at
- Unknown
- 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 and evacuate smoke and suction. Healthcare providers rely on this device to facilitate minimally invasive procedures.
Why This Is Dangerous
The software algorithm in the insufflation unit may malfunction, potentially resulting in excessive pressure during surgical procedures. This can lead to serious complications for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must halt the use of this device immediately, which may disrupt scheduled procedures and require alternative methods of insufflation.
Practical Guidance
How to identify if yours is affected
- Locate the model number UHI on the device.
- Check for any recall notification received from Olympus.
- Ensure your unit is one of the 18 recalled units.
Where to find product info
The model number can typically be found on the device's label or user manual.
What timeline to expect
Expect a processing time of 4-6 weeks for refunds or replacements once initiated.
If the manufacturer is unresponsive
- Document all attempts to contact Olympus.
- Follow up with a second communication if no response is received within two weeks.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Verify product recalls before purchase.
- Select devices from reputable manufacturers with strong safety records.
- Understand the safety features and software reliability of medical devices.
Documentation advice
Keep records of all communications with Olympus, including emails and phone call notes. Save any recall notices and receipts related to the device.
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Product Details
The Olympus High Flow Insufflation Unit, model number UHI, is designed for insufflation of the abdominal cavity, automatic suction, and smoke evacuation during laparoscopic procedures. This product was distributed nationwide. The quantity recalled is 18 units.
Key Facts
- Recall date: January 16, 2026
- Quantity recalled: 18 units
- Product used in laparoscopic procedures
- Software issue may cause overpressure events
- Immediate action required from users
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Safety Guide
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