Olympus Corporation of the Americas Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
UDI-DI: 04953170324147, All Serial Numbers
Products Sold
UDI-DI: 04953170324147; All Serial Numbers
Olympus Corporation of the Americas is recalling Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery. due to There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. Thes. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 olympus5578@sedgwick.com 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026