FDA recall Z-1352-2026

Olympus Corporation of the Americas · Class I · device

Product

Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

Reason for recall

Issue with software algorithm which may lead to overpressure events.

Distribution

Nationwide distribution

Key facts

Status: Ongoing
Initiation date: 2026-01-16
Report date: 2026-02-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2026