FDAFDA · Food and drugs·Recall number Z-2721-2026
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Published July 22, 2026 · Recall initiated: May 5, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- Lot
- Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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