Olympus High-Flow Insufflation Unit Model UHI-4 Recalled for Cardiac Complications
Olympus recalls the UHI-4 High-Flow Insufflation Unit used in laparoscopic surgery after reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures. Incidents may result from over insufflation of the abdominal cavity.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls never score below 4. The reported cardiac arrhythmias and short cardiac arrests during surgery constitute significant injury reports.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus High-Flow Insufflation Unit, Model UHI-4, a device used in laparoscopic surgical procedures. Following reports of patients experiencing cardiac arrhythmias and short cardiac arrests during procedures where the UHI-4 was used, the manufacturer initiated this recall. These cardiac events may have resulted from over insufflation of the abdominal cavity caused by the device.
Approximately 3,136 units have been distributed nationwide. All serial numbers of the UHI-4 model are included in the recall. The device is identified by UDI-DI: 04953170324147.
Those with UHI-4 devices should contact Olympus Corporation of the Americas for further guidance regarding this recall.
The recalled product
- Product
- Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,136
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)
- UDI-DI: 04953170324147
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · cardiac arrhythmia
See all →- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighInfinity M500 Cardiac Monitor Poses Electrical Shock Risk
FDA (Devices) · 2024-07-03
- SevereRadiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect
FDA (Devices) · 2020-05-06
- SevereSt. Jude Medical Recalls Ellipse ICD Devices for Therapy Failure Risk
FDA (Devices) · 2016-05-18
Similar recalls
- SevereOlympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk
FDA (Devices) · 2026-02-25
- SevereOlympus High Flow Insufflation Unit Recalled Due to Software Algorithm Issue
FDA (Devices) · 2026-02-25
- CriticalOlympus High Flow Insufflation Unit Model UHI-2 Recalled Due to Software Issue
FDA (Devices) · 2026-02-25
- HighOlympus Insufflation Unit UHI-4 Recalled for Air Supply Failure
FDA (Devices) · 2024-04-03
- HighOlympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
FDA (Devices) · 2026-07-29
- HighOlympus tracheal intubation fiberscope recalled due to suction flow specification issue
FDA (Devices) · 2023-12-20