FDAHealthMay 5, 2026

Olympus Corporation of the Americas — 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: May 5, 2026

Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.

What's affected?

Product: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Brand: Olympus Corporation of the Americas
Lot code: s

Additional details

Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 3,663 units.

View original FDA notice →

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