Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-0075-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 22, 2023

Date Posted: October 25, 2023

Recall Number: Z-0075-2024

Event ID: 92932

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.

Status: Ongoing

Product Quantity: 3136 units

Code Information:

UDI-DI: 04953170324147; All Serial Numbers

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated