Olympus Corporation Of The Americas recalls Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.

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.

Olympus notified consignees on about 06/05/2026 via Courier, 2-day delivery. Consignees were requested to examine inventory for affected units. If affected units are on hand, replace any existing sterilization instructions for these products with those provided with the notification and add these instructions to any existing copies of the IFU. Consignees were also instructed to acknowledge receipt of the customer letter through the web portal. If affected units were further distributed, Olympus instructed consignees to identify those customers and forward the notification to them. An updated notice was sent to consignees on 06/30/2026 with further clarification regarding instructions to be used to sterilize affected devices going forward.

• FDA enforcement recordOfficial FDA database entry for Z-2721-2026
• FDA device classification · KQTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.4370The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.