FDA recall, , High risk
Olympus High Flow Insufflation Unit
The Olympus High Flow Insufflation Unit has a software issue that may lead to overpressure events.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, based in Center Valley, Pennsylvania, began a recall on January 16, 2026, for its Olympus High Flow Insufflation Units due to a software algorithm issue that may lead to overpressure events.
The recall, added to the FDA's Enforcement Report on February 18, 2026, covers nationwide distribution of the UHI-3, UHI-2, and UHI models, which are used for insufflation of the abdominal cavity and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus High Flow Insufflation Unit.
- Model
- UHI-3
- UDI-DI
- 04953170140280
- 04953170140297
- Lot code
- All Serial Numbers.
Recall details
- Company began the recall
- Sold in
Nationwide distribution
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Software defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98243
- Recall numbers
- Z-1352-2026 to Z-1354-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
