Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic

FDA device recall Z-1353-2026 · posted 2026-02-18 · Open, Classified

Recall details

Recalling firm

Olympus Corporation of the Americas

Reason for recall

Issue with software algorithm which may lead to overpressure events.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

HIF

Quantity affected

744 units

Distribution

Nationwide distribution

Date initiated

2026-01-16

Date posted

2026-02-18

Location

Center Valley, PA

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