Recall Z-1352-2026 ยท HIF Insufflator, Laparoscopic
Olympus Corporation of the Americas
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
| Date | Feb 18, 2026 (initiated Jan 16, 2026) |
| Status | Open, Classified |
| Reason | Issue with software algorithm which may lead to overpressure events. |
| Root cause | Software design |
| Action | Olympus notified consignees on about 01/16/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were instructed to cease usage of the affected product immediately. They are advised to use available alternatives including an existing UHI-4 if available or switching to an insufflation device from another manufacturer. If no alternative is available on site, contact Olympus to arrange a loaner or purchase a replacement. Additionally, consignees were instructed to examine inventory and quarantine any identified devices, immediately cease usage of any UHI, UHI-2, and/or UHI-3 in inventory, |
| Quantity | 18 units |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953162 | OLYMPUS HIGH FLOW INSUFFLATION UNIT Olympus America, Inc., Dec 19, 1995 |