Olympus Insufflation Unit UHI-4 Recalled for Air Supply Failure
Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with no reported injuries or illnesses in the recall notice. Loss of air supply during endoscopic procedures represents a potential patient safety risk, matching the Score 3 criterion: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas has recalled the UHI-4 insufflation unit, a medical device used to supply air during endoscopic procedures. Olympus identified an increased trend of repairs and customer complaints reporting that the device stops supplying air when the front panel LED turns off.
The recall affects 3,172 units distributed nationwide. All serial numbers of the UHI-4 model are included in the recall.
Loss of air supply during an endoscopic procedure poses a patient safety concern. The recall notice does not report any injuries or illnesses associated with this issue.
The recalled product
- Product
- Insufflation unit, UHI-4.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,172
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model and serial number: UHI-4: UDI/DI: 04953170324147
- All serial numbers.
Distribution
Distributed nationwide across the United States.
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