FDA-Device2026-07-22Class IIPROCESSING DEFECT
Olympus Glass Body for 194 Ellik Evacuator recalled for inadequate sterilization
OTHERNationwide distribution
Olympus Ellik Evacuator glass body recalled for sterilization issue
Olympus has recalled the Glass Body for the 194 Ellik Evacuator (Model 190A) because some sterilization instructions in the user manual may not reliably make the device sterile. The affected sterilization parameters should no longer be used.
- If you use or manage this device, contact Olympus or your supplier immediately for updated sterilization instructions.
- Do not use the sterilization parameters listed in the original manual until you receive corrected guidance.
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
Affected count
3,663 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2721-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-07-22Olympus Ellik Evacuator Model 194 recalled for inadequate sterilization parameters
- FDA-Device2026-07-22Olympus Toomey Evacuator 30cc with Adaptor recalled for inadequate sterilization
- FDA-Device2026-07-22Olympus Toomey Evacuator 50cc Model 188A recalled for inadequate sterilization parameters
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