Recall Z-1353-2026— Olympus Corporation of the Americas

Name: FDA recall Z-1353-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-16

Class I · Ongoing

Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-01-16. It names one FDA 510(k) clearance: K953162. Product: 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.. Reason: Issue with software algorithm which may lead to overpressure events..

Recalling firm: Olympus Corporation of the Americas
Classification: Class I
Status: Ongoing
Initiated: 2026-01-16
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K953162 — OLYMPUS HIGH FLOW INSUFFLATION UNITOlympus America, Inc.·cleared 1995-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Issue with software algorithm which may lead to overpressure events.

Data sourced from openFDA. This site is unofficial and independent of the FDA.