Z-0075-2024Class I

Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery

Name: Z-0075-2024 Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery
Creator: Olympus Corporation of the Americas
Published: 2023-09-22
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-09-22 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery on 2023-09-22. FDA classified it as Class I and gives the reason as "There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0075-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-09-22
Posted: 2023-10-18
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Product code: HIF Insufflator, Laparoscopic
Reason for recall: There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
FDA root cause: Under Investigation by firm
Action: An URGENT: MEDICAL DEVICE CORRECTIVE ACTION notification letter dated 9/22/23 was sent to customers. Action steps to be taken by the end user: Our records indicate that your facility has purchased one or more of the Olympus UHI-4. Olympus requires you to take the following actions: 1. Carefully read the content of this Field Corrective Action Letter. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this letter. 3. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at [email protected] or by fax at 866-367-6717. For any questions about the acknowledgement form, please call the Sedgwick team at 855-215-4972. 4. If you have further distributed this product, identify your customers, and forward them this Letter. Please appropriately document your notification process and let us know the end-customer feedback accordingly. Olympus requests that you report complaints, including any injuries associated with over insufflation during the procedure with UHI-4, to Olympus. Please report complaints to Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. An URGENT: MEDICAL DEVICE CORRECTIVE ACTION - UPDATE notification letter dated 10/25/23 was sent to customers. Action steps to be taken by the end user: Our records indicate that your facility has purchased one or more of the Olympus UHI-4. Olympus requires you to take the following actions: 1. Inspect your inventory and identify any UHI-4 High flow insufflation unit(s). Quarantine and mark your units appropriately by your site to prevent usage. If your facility does not have alternatives or is unable to obtain alternatives, you may choose to use the UHI-4 while using extreme caution and after reviewing the information above
Quantity in commerce: 3136 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 04953170324147; All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0075-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0075-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-18

Product code HIF

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)