Z-1353-2026Class I

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

Name: Z-1353-2026 Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and...
Creator: Olympus Corporation of the Americas
Published: 2026-01-16
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-01-16 / Open, Classified / root cause: software

FDA source

Olympus Corporation of the Americas began a recall of Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to... on 2026-01-16. FDA classified it as Class I and gives the reason as "Issue with software algorithm which may lead to overpressure events". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1353-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-01-16
Posted: 2026-02-18
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Product code: HIF Insufflator, Laparoscopic
Reason for recall: Issue with software algorithm which may lead to overpressure events.
Root cause tag: software
FDA 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, 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].
Quantity in commerce: 744 units
Distribution: Nationwide distribution
Product codes and lots: Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1353-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1352-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-18
Z-1353-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-18
Z-1354-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-25	2026-02-18

Product code HIF

K953162Class IIOlympus High Flow Insufflation UnitOlympus America, Inc. / cleared 1995-12-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)