Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. recall (Olympus Corporation of the Americas)
Medical deviceClass IIOngoing
Summary: Olympus Corporation of the Americas is recalling Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.. 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.
What is being recalled
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
How to tell if yours is affected
Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2721-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 5, 2026 |
| Reported | July 22, 2026 |
| Company | Olympus Corporation of the Americas |
| Company location | Center Valley, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3,663 units |
More recalls from Olympus Corporation of the Americas · all medical device recalls · recalls from May 2026