Olympus Corporation of the Americas: Medical Device Recall in 2026 - (Recall #: Z-1353-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: January 16, 2026

Date Posted: February 25, 2026

Recall Number: Z-1353-2026

Event ID: 98243

Reason for Recall:

Issue with software algorithm which may lead to overpressure events.

Status: Ongoing

Product Quantity: 744 units

Code Information:

Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated