—#218006

Product

Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

FDA product code: HIF — Insufflator, Laparoscopic
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K014166
Affected lot / code info: Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.

Why it was recalled

Issue with software algorithm which may lead to overpressure events.

Root cause (FDA determination)

Software design

Action the firm took

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, call Olympus Customer Service at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return your device. Consignees were also requested to acknowledge receipt of this letter through their recall web portal as follows: a. Go to https://olympusamerica.com/recall, b. Enter the recall number "0489 and c. Complete the form as instructed. Please indicate in your response if you no longer have the device(s). If any consignees have further distributed this UHI product, they were instructed to identify affected customers and forward this notice to them immediately. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 or by email at Cynthia.Ow@Olympus.com.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Nationwide distribution

Timeline

Recall initiated: 2026-01-16
Posted by FDA: 2026-02-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218006. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.