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HIGH FLOW INSUFFLATION UNIT recallZ-1354-2026 · Olympus Corporation of the Americas · initiated Jan 16, 2026

Class I Open, Classified All recalls posted in February 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Issue with software algorithm which may lead to overpressure events.

FDA root cause category: Software design

What the company is doing

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 [email protected].

Recall details

Recall number
Z-1354-2026
Recall class
Class I (most serious)
Status
Open, Classified
Initiated by the company
Jan 16, 2026
Posted by the FDA
Feb 18, 2026
Recalling firm
Olympus Corporation of the Americas
Quantity
485 units
Product code
HIF
FDA submissions
K014166
Distribution
Nationwide distribution

Product description

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.

Code information (models, lots, serial numbers)

Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K014166 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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