Recall Z-2719-2026— Olympus Corporation of the Americas

Name: FDA recall Z-2719-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-05

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2026-05-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.. Reason: Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2026-05-05
Firm location: Center Valley, PA, United States

Product description

Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.

Reason for recall

Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.

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